Trial Outcomes & Findings for Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant (NCT NCT01419795)
NCT ID: NCT01419795
Last Updated: 2017-07-27
Results Overview
Estimated using the Kaplan-Meier method in all cohorts.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
12 months
Results posted on
2017-07-27
Participant Flow
Participant milestones
| Measure |
Arm I (Lenalidomide, Rituximab)
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
—
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Estimated using the Kaplan-Meier method in all cohorts.
Outcome measures
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
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)
|
0.33 survival probability
Interval 0.067 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Assessed up to 18 monthsPopulation: No participants enrolled in the second arm.
Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
Outcome measures
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Rate of Response (CR, PR, or SD) and Time to Progression
|
0.67 progression free survival probability
Interval 0.3 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Assessed up to 30 days after completion of study treatmentPopulation: No participants enrolled in the second arm.
Outcome measures
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Assessed up to 30 days after completion of study treatmentPopulation: No participants enrolled in the second arm.
Outcome measures
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Assessed up to 18 monthsPopulation: No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.
Outcome measures
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From baseline to day 28 of course 3Population: With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 30 days after completion of study treatmentPopulation: No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.
Outcome measures
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 Participants
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
|
7 Number of adverse events
|
—
|
SECONDARY outcome
Timeframe: Baseline, day 7 and 28 of course 1, and day 28 of course 3Population: With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 7 and 28 of course 1, and day 28 of course 3Population: With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Lenalidomide, Rituximab)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Lenalidomide)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Lenalidomide, Rituximab)
n=3 participants at risk
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
|
Arm II (Lenalidomide)
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
|
|---|---|---|
|
Vascular disorders
Superior vena cava obstruction
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Metabolism and nutrition disorders
Tumor flare syndrome
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Rash >50% BSA
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mohamed Sorror
Fred Hutchinson Cancer Research Center
Phone: 206-667-6298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place