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← Revlimid: recurrent mantle cell lymphoma after prior therapy

NCT00783367 · STUDY IN CONTEXT

Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas

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.

primary · POSTED

Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999).

Source null

→

secondary · POSTED

Progression free survival time in months

Subjects who received both Revlimid and rituximab were evaluable for response

→

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-mantle-cell-lymphoma-revlimid-da54db8f
nct id
NCT00783367
trial label
Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas
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
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    outcome key
    om-0000
    source section id
    NCT00783367-om-0000
    source outcome index
    0
    endpoint
    Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance
    endpoint definition
    Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999).
    time origin
    3 months
    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-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    outcome key
    om-0001
    source section id
    NCT00783367-om-0001
    source outcome index
    1
    endpoint
    Time Until Progression After Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphomas With Rituximab Resistance
    endpoint definition
    Progression free survival time in months
    time origin
    9 years from enrollment of first subject
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Subjects who received both Revlimid and rituximab were evaluable for response
    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-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1
    regimen
    Revlimid + rituximab with dexamethasone
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00783367-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 2
    regimen
    Revlimid + rituximab (without dexamethasone)
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00783367-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 1
    regimen
    Revlimid + rituximab with dexamethasone
    analyzed count
    26
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00783367-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort 2
    regimen
    Revlimid + rituximab (without dexamethasone)
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00783367-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    harm key
    EG000
    source section id
    NCT00783367-ae
    event group key
    EG000
    event group label
    Cohort 1
    serious affected
    12
    serious at risk
    27
    other affected
    27
    other at risk
    27
    frequency threshold
    5
    collection period
    Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
    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-mantle-cell-lymphoma-revlimid-da54db8f
    nct id
    NCT00783367
    harm key
    EG001
    source section id
    NCT00783367-ae
    event group key
    EG001
    event group label
    Cohort 2
    serious affected
    9
    serious at risk
    23
    other affected
    22
    other at risk
    23
    frequency threshold
    5
    collection period
    Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
    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