NCT00924040 · STUDY IN CONTEXT

Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory 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

Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils \>/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.

Source null

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secondary · POSTED

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

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secondary · POSTED

Patients are assessed by MRI to determine which ones resolve their marrow abnormality. A non-parametric Wilcoxon test was to be used to determine whether CR correlated with resolution of MRI abnormality

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secondary · POSTED

Fresh malignant cells are isolated from blood, bone marrow, lymph nodes or other tissue and incubated with recombinant immunotoxins to determine sensitivity to BL22 and other agents to estimate the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.

Source null

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secondary · POSTED

Although some hairy cell leukemia (HCL) cells from some patients may have ex vivo sensitivity, they might not respond clinically. Number of participants with pretreatment ex vivo sensitivity (\<10 ng/ml IC50) who go on to achieve CR as best response. CR required abscence of HCL in the bone marrow and resolution of cytopenias.

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secondary · POSTED

CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered \<3 ng/ml for sCD25, and \<2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.

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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 Months to Response to Treatment

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: NCT00924040
qol key: qol-0000
source section id: NCT00924040-om-0000
source outcome index: 0
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Number of Months to Response to Treatment
measure definition: Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils \>/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.
time frame: 2/14/2009 till 6/24/2010
analysis role: primary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
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: NCT00924040
trial label: Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory 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: 1
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0000
source section id
NCT00924040-om-0000
source outcome index
0
endpoint
Number of Months to Response to Treatment
endpoint definition
Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils \>/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.
time origin
2/14/2009 till 6/24/2010
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0001
source section id
NCT00924040-om-0001
source outcome index
1
endpoint
Number of Participants With Adverse Events
endpoint definition
Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
time origin
2 years & 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0002
source section id
NCT00924040-om-0002
source outcome index
2
endpoint
Number of Participants With Complete Response (CR) Who Resolve the Bone Marrow Abnormality by Magnetic Resonance Imaging (MRI)
endpoint definition
Patients are assessed by MRI to determine which ones resolve their marrow abnormality. A non-parametric Wilcoxon test was to be used to determine whether CR correlated with resolution of MRI abnormality
time origin
Bone marrow biopsy and MRI 4 weeks after patients meeting blood criteria for CR, and if CR is present, repeat bone marrow biopsy and MRI every 12 months. Bone marrow biopsy and MRI is not done in patients with PR as best response.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0003
source section id
NCT00924040-om-0003
source outcome index
3
endpoint
Number of Patients Who Developed Neutralizing Antibodies After One or More Cycles of BL22
endpoint definition
Fresh malignant cells are isolated from blood, bone marrow, lymph nodes or other tissue and incubated with recombinant immunotoxins to determine sensitivity to BL22 and other agents to estimate the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.
time origin
24 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0004
source section id
NCT00924040-om-0004
source outcome index
4
endpoint
Number of Patients With ex Vivo Sensitivity Who Respond Clinically
endpoint definition
Although some hairy cell leukemia (HCL) cells from some patients may have ex vivo sensitivity, they might not respond clinically. Number of participants with pretreatment ex vivo sensitivity (\<10 ng/ml IC50) who go on to achieve CR as best response. CR required abscence of HCL in the bone marrow and resolution of cytopenias.
time origin
Time to CR can be between 2 months and 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0005
source section id
NCT00924040-om-0005
source outcome index
5
endpoint
Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25
endpoint definition
CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered \<3 ng/ml for sCD25, and \<2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.
time origin
patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0000
arm key
OG000
arm label
BL22 Immunotherapy
regimen
30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00924040-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0001
arm key
OG000
arm label
BL22 Immunotherapy
regimen
30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00924040-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0002
arm key
OG000
arm label
BL22 Immunotherapy
regimen
30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00924040-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0003
arm key
OG000
arm label
BL22 Immunotherapy
regimen
30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00924040-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0004
arm key
OG000
arm label
BL22 Immunotherapy
regimen
30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00924040-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
outcome key
om-0005
arm key
OG000
arm label
BL22 Immunotherapy
regimen
30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00924040-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
harm key
EG000
source section id
NCT00924040-ae
event group key
EG000
event group label
BL22 Immunotherapy
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
Source null
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

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00924040
qol key
qol-0000
source section id
NCT00924040-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Number of Months to Response to Treatment
measure definition
Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils \>/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.
time frame
2/14/2009 till 6/24/2010
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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