MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

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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.

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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.

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secondary · POSTED

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

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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-aggressive-b-cell-non-hodgkin-lymphoma
nct id: NCT00089076
trial label: MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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

release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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

release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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

release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
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