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← Hairy Cell Leukemia

NCT00586924 · STUDY IN CONTEXT

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Adverse events are suspected of causal relationship to drug and are \>=Grade (G) 3 in severity considered DLTs: G 3 or 4 hematologic abnormalities at baseline due to disease were not evaluable for hematologic DLT, G 2 allergic reactions of bronchospasm or urticaria, or any \>= G3 allergic reaction, in presence of pre-medication were considered DLTs. Following \>= G 3 non-hematological treatment-related toxicities not considered DLTs: Tumor lysis syndrome, G 3 low electrolyte levels with pre-existing low levels of same electrolytes, anticoagulant therapy, G 3 or 4 infection or neutropenic fever unless relationship to IP is suspected, G 3 transaminase, alkaline phosphatase, bilirubin or other liver function test elevation provided resolution to values required for study entry prior to start of next cycle, G 3 fever, G 3 hypertriglyceridemia and hypercholesterolemia, and G 4 hypertriglyceridemia lasting \<2 months, G 3 hypoalbuminemia lasting \<7 days occurred in absence of CLS.

Evaluable population for DLT included all participants who received any treatment of moxetumomab pasudotox, completed at least Cycle 2 Day 10, or discontinued treatment due to a DLT on or before Cycle 2 Day 10.

→

primary · POSTED

The TEAEs are defined as adverse events (AEs) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

→

primary · POSTED

Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

→

primary · POSTED

Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

→

primary · POSTED

An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

→

primary · POSTED

Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils \>= 1,500/mcL, Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: \>=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils \>= 1,500/mcL, Platelets \>=100,000/mcL, and Hemoglobin \>= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00586924
qol key
qol-0005
source section id
NCT00586924-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)
measure definition
Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils \>= 1,500/mcL, Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: \>=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils \>= 1,500/mcL, Platelets \>=100,000/mcL, and Hemoglobin \>= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks.
time frame
From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Safety population included all participants who received any treatment of moxetumomab pasudotox.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Number of Participants With Complete Response (CR)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00586924
qol key
qol-0006
source section id
NCT00586924-om-0006
source outcome index
6
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Number of Participants With Complete Response (CR)
measure definition
The CR is defined by: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as exhibited by: Neutrophils \>= 1,500/microliter (mcL), Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gram per deciliter (gm/dL) without transfusions or growth factors for at least 4 weeks.
time frame
From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Safety population included all participants who received any treatment of moxetumomab pasudotox.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Number of Participants With Partial Response (PR)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00586924
qol key
qol-0007
source section id
NCT00586924-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Number of Participants With Partial Response (PR)
measure definition
Partial response requires all of the following: \>=50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, \>=50% reduction in lymphadenopathy, \>=50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam, Neutrophils \>= 1,500/mcL or 50% improvement over baseline without growth factors for at least 4 weeks, Platelets \>=100,000/mcL or 50% improvement over baseline, and Hemoglobin \>= 11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks. For participants who are transfusion-dependent at baseline, a hemoglobin of \>= 9.0 g/dL without transfusions or growth factors for at least 4 weeks.
time frame
From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Safety population included all participants who received any treatment of moxetumomab pasudotox.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00586924
trial label
A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
6
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    source section id
    NCT00586924-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Dose Limiting Toxicities (DLTs)
    endpoint definition
    Adverse events are suspected of causal relationship to drug and are \>=Grade (G) 3 in severity considered DLTs: G 3 or 4 hematologic abnormalities at baseline due to disease were not evaluable for hematologic DLT, G 2 allergic reactions of bronchospasm or urticaria, or any \>= G3 allergic reaction, in presence of pre-medication were considered DLTs. Following \>= G 3 non-hematological treatment-related toxicities not considered DLTs: Tumor lysis syndrome, G 3 low electrolyte levels with pre-existing low levels of same electrolytes, anticoagulant therapy, G 3 or 4 infection or neutropenic fever unless relationship to IP is suspected, G 3 transaminase, alkaline phosphatase, bilirubin or other liver function test elevation provided resolution to values required for study entry prior to start of next cycle, G 3 fever, G 3 hypertriglyceridemia and hypercholesterolemia, and G 4 hypertriglyceridemia lasting \<2 months, G 3 hypoalbuminemia lasting \<7 days occurred in absence of CLS.
    time origin
    Cycle 1 Day 1 to Cycle 2 Day 10 (each cycle duration was 28 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable population for DLT included all participants who received any treatment of moxetumomab pasudotox, completed at least Cycle 2 Day 10, or discontinued treatment due to a DLT on or before Cycle 2 Day 10.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    source section id
    NCT00586924-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
    endpoint definition
    The TEAEs are defined as adverse events (AEs) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox.
    time origin
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0002
    source section id
    NCT00586924-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
    endpoint definition
    Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension.
    time origin
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0003
    source section id
    NCT00586924-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
    endpoint definition
    Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree.
    time origin
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0004
    source section id
    NCT00586924-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
    endpoint definition
    An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.
    time origin
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0005
    source section id
    NCT00586924-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)
    endpoint definition
    Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils \>= 1,500/mcL, Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: \>=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils \>= 1,500/mcL, Platelets \>=100,000/mcL, and Hemoglobin \>= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks.
    time origin
    From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    arm key
    OG000
    arm label
    5 mcg/kg
    regimen
    Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    arm key
    OG001
    arm label
    10 mcg/kg
    regimen
    Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    arm key
    OG002
    arm label
    20 mcg/kg
    regimen
    Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    arm key
    OG003
    arm label
    30 mcg/kg
    regimen
    Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    arm key
    OG004
    arm label
    40 mcg/kg
    regimen
    Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0000
    arm key
    OG005
    arm label
    50 mcg/kg
    regimen
    Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    arm key
    OG000
    arm label
    5 mcg/kg
    regimen
    Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0001#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    arm key
    OG001
    arm label
    10 mcg/kg
    regimen
    Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0001#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    arm key
    OG002
    arm label
    20 mcg/kg
    regimen
    Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0001#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    arm key
    OG003
    arm label
    30 mcg/kg
    regimen
    Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0001#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    arm key
    OG004
    arm label
    40 mcg/kg
    regimen
    Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0001#groups/OG004
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    outcome key
    om-0001
    arm key
    OG005
    arm label
    50 mcg/kg
    regimen
    Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00586924-om-0001#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    harm key
    EG000
    source section id
    NCT00586924-ae
    event group key
    EG000
    event group label
    5 mcg/kg
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    harm key
    EG001
    source section id
    NCT00586924-ae
    event group key
    EG001
    event group label
    10 mcg/kg
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    harm key
    EG002
    source section id
    NCT00586924-ae
    event group key
    EG002
    event group label
    20 mcg/kg
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    harm key
    EG003
    source section id
    NCT00586924-ae
    event group key
    EG003
    event group label
    30 mcg/kg
    serious affected
    2
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    harm key
    EG004
    source section id
    NCT00586924-ae
    event group key
    EG004
    event group label
    40 mcg/kg
    serious affected
    0
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    harm key
    EG005
    source section id
    NCT00586924-ae
    event group key
    EG005
    event group label
    50 mcg/kg
    serious affected
    4
    serious at risk
    33
    other affected
    33
    other at risk
    33
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    qol key
    qol-0005
    source section id
    NCT00586924-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)
    measure definition
    Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils \>= 1,500/mcL, Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: \>=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils \>= 1,500/mcL, Platelets \>=100,000/mcL, and Hemoglobin \>= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks.
    time frame
    From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    qol key
    qol-0006
    source section id
    NCT00586924-om-0006
    source outcome index
    6
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Number of Participants With Complete Response (CR)
    measure definition
    The CR is defined by: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as exhibited by: Neutrophils \>= 1,500/microliter (mcL), Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gram per deciliter (gm/dL) without transfusions or growth factors for at least 4 weeks.
    time frame
    From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00586924
    qol key
    qol-0007
    source section id
    NCT00586924-om-0007
    source outcome index
    7
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Number of Participants With Partial Response (PR)
    measure definition
    Partial response requires all of the following: \>=50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, \>=50% reduction in lymphadenopathy, \>=50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam, Neutrophils \>= 1,500/mcL or 50% improvement over baseline without growth factors for at least 4 weeks, Platelets \>=100,000/mcL or 50% improvement over baseline, and Hemoglobin \>= 11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks. For participants who are transfusion-dependent at baseline, a hemoglobin of \>= 9.0 g/dL without transfusions or growth factors for at least 4 weeks.
    time frame
    From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Safety population included all participants who received any treatment of moxetumomab pasudotox.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice