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NCT00072514 · STUDY IN CONTEXT

Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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.

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-non-hodgkin-lymphoma-zydelig-b71fbc34
nct id
NCT00072514
trial label
Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0000
    source section id
    NCT00072514-om-0000
    source outcome index
    0
    endpoint
    Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules
    endpoint definition
    Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.
    time origin
    At 3-4 weeks after completion of study treatment
    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-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0001
    source section id
    NCT00072514-om-0001
    source outcome index
    1
    endpoint
    Overall and Complete Response Rates
    endpoint definition
    Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)
    time origin
    3-4 weeks after completion of study treatment
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0002
    source section id
    NCT00072514-om-0002
    source outcome index
    2
    endpoint
    Hematologic and Non-hematologic Adverse Events.
    endpoint definition
    Count of participants with grade 3/4 hematologic and non-hematologic adverse events.
    time origin
    3-4 weeks after completion of study treatment
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0003
    source section id
    NCT00072514-om-0003
    source outcome index
    3
    endpoint
    Peripheral Blood Stem Cell Collection
    endpoint definition
    Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.
    time origin
    Up to 12 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Successful PBSC collection is only considered in those patients that attempted PBSC collection.
    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-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment
    regimen
    Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00072514-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment
    regimen
    Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00072514-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment
    regimen
    Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00072514-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment
    regimen
    Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00072514-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-zydelig-b71fbc34
    nct id
    NCT00072514
    harm key
    EG000
    source section id
    NCT00072514-ae
    event group key
    EG000
    event group label
    Treatment
    serious affected
    0
    serious at risk
    51
    other affected
    45
    other at risk
    51
    frequency threshold
    5
    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