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← KEYTRUDA: refractory Hodgkin Lymphoma

NCT00837200 · STUDY IN CONTEXT

Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

* Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU * Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles * MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion * Stable disease \> 2mo was a response

Source null

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primary · POSTED

Study Specific Measure (Response)

Source null

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primary · POSTED

Study Specific Measure (Number of Participants Taken Off Study)

Source null

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00837200
trial label
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    outcome key
    om-0000
    source section id
    NCT00837200-om-0000
    source outcome index
    0
    endpoint
    Tumor Response
    endpoint definition
    * Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU * Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles * MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion * Stable disease \> 2mo was a response
    time origin
    16 weeks
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    outcome key
    om-0001
    source section id
    NCT00837200-om-0001
    source outcome index
    1
    endpoint
    Study Specific Measure (Response)
    endpoint definition
    Study Specific Measure (Response)
    time origin
    16 Weeks
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    outcome key
    om-0002
    source section id
    NCT00837200-om-0002
    source outcome index
    2
    endpoint
    Study Specific Measure (Number of Participants Taken Off Study)
    endpoint definition
    Study Specific Measure (Number of Participants Taken Off Study)
    time origin
    16 weeks
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    outcome key
    om-0000
    arm key
    OG000
    arm label
    ODD Regimen
    regimen
    Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00837200-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    outcome key
    om-0001
    arm key
    OG000
    arm label
    ODD Regimen
    regimen
    Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00837200-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    outcome key
    om-0002
    arm key
    OG000
    arm label
    ODD Regimen
    regimen
    Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00837200-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00837200
    harm key
    EG000
    source section id
    NCT00837200-ae
    event group key
    EG000
    event group label
    ODD Regimen
    serious affected
    9
    serious at risk
    13
    other affected
    13
    other at risk
    13
    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
    setting source links

      Preserved source evidence · Not medical advice