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← Truxima: refractory Non-Hodgkin's Lymphoma

NCT00089076 · STUDY IN CONTEXT

MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma

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

Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.

Source null

→

secondary · POSTED

The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

No participants proceeded to Phase 2 for evaluation.

→

secondary · POSTED

The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.

No participants proceeded to Phase 2 for evaluation.

→

secondary · POSTED

Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.

No participants proceeded to Phase 2 for evaluation.

→

secondary · POSTED

Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy

The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.

→

secondary · POSTED

Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy

The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.

→

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-truxima-09fad21d
nct id
NCT00089076
trial label
MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0000
    source section id
    NCT00089076-om-0000
    source outcome index
    0
    endpoint
    Number of Overall Confirmed Responses(Complete Response or Partial Response)
    endpoint definition
    Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
    time origin
    From registration to month 7
    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-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0001
    source section id
    NCT00089076-om-0001
    source outcome index
    1
    endpoint
    Time to Progression (Phase 2)
    endpoint definition
    The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
    time origin
    From registration to progression (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No participants proceeded to Phase 2 for evaluation.
    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-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0002
    source section id
    NCT00089076-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (Phase 2)
    endpoint definition
    The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
    time origin
    From registration to death (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No participants proceeded to Phase 2 for evaluation.
    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-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0003
    source section id
    NCT00089076-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (Phase 2)
    endpoint definition
    Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.
    time origin
    From response to progression (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No participants proceeded to Phase 2 for evaluation.
    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-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0004
    source section id
    NCT00089076-om-0004
    source outcome index
    4
    endpoint
    Mean Change in % of CD3+CD4+ for Marker HLA-DR+
    endpoint definition
    Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
    time origin
    Before treatment to 1 month after therapy initiation
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.
    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-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0005
    source section id
    NCT00089076-om-0005
    source outcome index
    5
    endpoint
    Mean Change in % of CD3+CD4- for Marker HLA-DR+
    endpoint definition
    Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
    time origin
    Before treatment to 1 month after therapy initiation
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.
    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-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0000
    arm key
    OG000
    arm label
    MDX-010
    regimen
    Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00089076-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0001
    arm key
    OG000
    arm label
    MDX-010
    regimen
    Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00089076-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0002
    arm key
    OG000
    arm label
    MDX-010
    regimen
    Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00089076-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0003
    arm key
    OG000
    arm label
    MDX-010
    regimen
    Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00089076-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0004
    arm key
    OG000
    arm label
    MDX-010
    regimen
    Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00089076-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    outcome key
    om-0005
    arm key
    OG000
    arm label
    MDX-010
    regimen
    Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00089076-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-truxima-09fad21d
    nct id
    NCT00089076
    harm key
    EG000
    source section id
    NCT00089076-ae
    event group key
    EG000
    event group label
    MDX-010
    serious affected
    8
    serious at risk
    18
    other affected
    16
    other at risk
    18
    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