Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-H

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

Estimated using the Kaplan-Meier method in all cohorts.

Primary objective could not be completed because there were no patients enrolled in the second experimental arm (lenalidomide). Additionally, having only three patients in one arm does not allow for a meaningful comparison to historic controls.

→

secondary · POSTED

Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.

No participants enrolled in the second arm.

→

secondary · POSTED

Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab

No participants enrolled in the second arm.

→

secondary · POSTED

Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD

No participants enrolled in the second arm.

→

secondary · POSTED

Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts

No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.

→

secondary · POSTED

Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide

With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.

→

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-t-cell-large-granular-lymphocyte-leukemia
nct id: NCT01419795
trial label: Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-H
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0000
source section id
NCT01419795-om-0000
source outcome index
0
endpoint
Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1)
endpoint definition
Estimated using the Kaplan-Meier method in all cohorts.
time origin
12 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Primary objective could not be completed because there were no patients enrolled in the second experimental arm (lenalidomide). Additionally, having only three patients in one arm does not allow for a meaningful comparison to historic controls.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0001
source section id
NCT01419795-om-0001
source outcome index
1
endpoint
Rate of Response (CR, PR, or SD) and Time to Progression
endpoint definition
Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
time origin
Assessed up to 18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No participants enrolled in the second arm.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0002
source section id
NCT01419795-om-0002
source outcome index
2
endpoint
Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
endpoint definition
Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
time origin
Assessed up to 30 days after completion of study treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No participants enrolled in the second arm.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0003
source section id
NCT01419795-om-0003
source outcome index
3
endpoint
Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
endpoint definition
Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
time origin
Assessed up to 30 days after completion of study treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No participants enrolled in the second arm.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0004
source section id
NCT01419795-om-0004
source outcome index
4
endpoint
Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
endpoint definition
Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
time origin
Assessed up to 18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0005
source section id
NCT01419795-om-0005
source outcome index
5
endpoint
Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
endpoint definition
Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
time origin
From baseline to day 28 of course 3
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0000
arm key
OG000
arm label
Arm I (Lenalidomide, Rituximab)
regimen
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0000
arm key
OG001
arm label
Arm II (Lenalidomide)
regimen
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0001
arm key
OG000
arm label
Arm I (Lenalidomide, Rituximab)
regimen
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0001
arm key
OG001
arm label
Arm II (Lenalidomide)
regimen
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0002
arm key
OG000
arm label
Arm I (Lenalidomide, Rituximab)
regimen
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0002
arm key
OG001
arm label
Arm II (Lenalidomide)
regimen
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0003
arm key
OG000
arm label
Arm I (Lenalidomide, Rituximab)
regimen
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0003
arm key
OG001
arm label
Arm II (Lenalidomide)
regimen
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0004
arm key
OG000
arm label
Arm I (Lenalidomide, Rituximab)
regimen
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0004
arm key
OG001
arm label
Arm II (Lenalidomide)
regimen
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0005
arm key
OG000
arm label
Arm I (Lenalidomide, Rituximab)
regimen
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
outcome key
om-0005
arm key
OG001
arm label
Arm II (Lenalidomide)
regimen
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01419795-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
harm key
EG000
source section id
NCT01419795-ae
event group key
EG000
event group label
Arm I (Lenalidomide, Rituximab)
serious affected
2
serious at risk
3
other affected
0
other at risk
3
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
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01419795
harm key
EG001
source section id
NCT01419795-ae
event group key
EG001
event group label
Arm II (Lenalidomide)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
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