CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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

The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.

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primary · POSTED

Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.

Source null

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primary · POSTED

The overall survival was evaluated using the Kaplan-Meier estimator.

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-non-hodgkin-lymphoma-truxima-09fad21d
nct id: NCT00290472
trial label: CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0000
source section id
NCT00290472-om-0000
source outcome index
0
endpoint
Objective Overall Response Rate
endpoint definition
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
time origin
Up to 6 years
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-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0001
source section id
NCT00290472-om-0001
source outcome index
1
endpoint
Duration of Response
endpoint definition
Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
time origin
Up to 6 years
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-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0002
source section id
NCT00290472-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
The overall survival was evaluated using the Kaplan-Meier estimator.
time origin
Up to 6 years
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

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0000
arm key
OG000
arm label
Aggressive B-cell Lymphoma
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0000
arm key
OG001
arm label
Follicular Lymphoma
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0000
arm key
OG002
arm label
Chronic Lymphocytic Leukemia
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0001
arm key
OG000
arm label
Aggressive B-cell Lymphoma
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0001
arm key
OG001
arm label
Follicular Lymphoma
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0001
arm key
OG002
arm label
Chronic Lymphocytic Leukemia
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0002
arm key
OG000
arm label
Aggressive B-cell Lymphoma
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0002
arm key
OG001
arm label
Follicular Lymphoma
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
outcome key
om-0002
arm key
OG002
arm label
Chronic Lymphocytic Leukemia
regimen
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00290472-om-0002#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00290472
harm key
EG000
source section id
NCT00290472-ae
event group key
EG000
event group label
Temsirolimus
serious affected
21
serious at risk
89
other affected
89
other at risk
89
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