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Trial record 56 of 138 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Immunologic Factors"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01419795
Recruitment Status : Terminated (Low accrual)
First Posted : August 18, 2011
Results First Posted : March 21, 2017
Last Update Posted : July 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mohamed Sorror, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Prolymphocytic Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Drug: lenalidomide
Biological: rituximab
Other: pharmacological study
Other: laboratory biomarker analysis
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 3 0
Completed 3 0
Not Completed 0 0
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 3 0 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 0 participants 3 participants
57
(48 to 62)
57
(48 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Female
1
  33.3%
1
  33.3%
Male
2
  66.7%
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
 100.0%
3
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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)
Hide Description Estimated using the Kaplan-Meier method in all cohorts.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
0.33
(0.067 to 1.00)
2.Secondary Outcome
Title Rate of Response (CR, PR, or SD) and Time to Progression
Hide Description Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
Time Frame Assessed up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants enrolled in the second arm.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: progression free survival probability
0.67
(0.30 to 1.00)
3.Secondary Outcome
Title Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
Hide Description [Not Specified]
Time Frame Assessed up to 30 days after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No participants enrolled in the second arm.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 0
Measure Type: Count of Participants
Unit of Measure: Participants
2
  66.7%
4.Secondary Outcome
Title Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
Hide Description [Not Specified]
Time Frame Assessed up to 30 days after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No participants enrolled in the second arm.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
Hide Description [Not Specified]
Time Frame Assessed up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
Hide Description [Not Specified]
Time Frame From baseline to day 28 of course 3
Hide Outcome Measure Data
Hide Analysis Population Description
With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
Hide Description [Not Specified]
Time Frame Assessed up to 30 days after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 0
Measure Type: Number
Unit of Measure: Number of adverse events
7
8.Secondary Outcome
Title Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses
Hide Description [Not Specified]
Time Frame Baseline, day 7 and 28 of course 1, and day 28 of course 3
Hide Outcome Measure Data
Hide Analysis Population Description
With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse
Hide Description [Not Specified]
Time Frame Baseline, day 7 and 28 of course 1, and day 28 of course 3
Hide Outcome Measure Data
Hide Analysis Population Description
With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/0    
Blood and lymphatic system disorders     
Neutropenia  1/3 (33.33%)  1 0/0  0
Metabolism and nutrition disorders     
Hyperglycemia  1/3 (33.33%)  1 0/0  0
Dehydration  1/3 (33.33%)  1 0/0  0
Tumor flare syndrome  1/3 (33.33%)  1 0/0  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1/3 (33.33%)  1 0/0  0
Skin and subcutaneous tissue disorders     
Rash >50% BSA  1/3 (33.33%)  1 0/0  0
Vascular disorders     
Superior vena cava obstruction  1/3 (33.33%)  1 0/0  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Lenalidomide, Rituximab) Arm II (Lenalidomide)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mohamed Sorror
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-6298
EMail: msorror@fredhutch.org
Layout table for additonal information
Responsible Party: Mohamed Sorror, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01419795     History of Changes
Other Study ID Numbers: 2467.00
NCI-2011-01703 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: August 15, 2011
First Posted: August 18, 2011
Results First Submitted: January 31, 2017
Results First Posted: March 21, 2017
Last Update Posted: July 27, 2017