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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01703 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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Low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To improve overall survival in patients with relapse of NHL or CLL/SLL/PLL within 180 days after allogeneic hematopoietic cell transplant (HCT).
SECONDARY OBJECTIVES:
I. Rate of response (complete response [CR], partial response [PR], or stable disease [SD]) and time to progression.
II. Grade III-IV toxicity.
III. Incidences of grades II-IV acute graft-versus-host disease (GVHD) and limited or extensive chronic GVHD.
IV. Compare efficacy and safety between the first, second and third cohorts.
V. Laboratory research studies for efficacy and toxicity: blood samples will be stored at baseline, day 7, and day 28 of cycle 1 and day 28 of cycle 3 to investigate:
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: 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 orally (PO) once daily (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 intravenously (IV) on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
ARM II: 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.
Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 60 days and then every 3 months for up to 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (lenalidomide, rituximab) | Experimental | 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. |
|
| Arm II (lenalidomide) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Estimated using the Kaplan-Meier method in all cohorts. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Response (CR, PR, or SD) and Time to Progression | Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100. | Assessed up to 18 months |
| Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab |
Not provided
Inclusion Criteria:
Understand and voluntarily sign an informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Patients with CLL/SLL/PLL or NHL and who:
Absolute neutrophil count (ANC) >= 1500/mm^3 or >= 1000/mm^3 if ANC has persistently < 1500/ mm^3 for more than 2 weeks
Platelet count (transfusion independent) >= 50,000/mm^3 or >= 20,000/mm^3 if platelet count has persistently < 50,000/mm^3 for more than 2 weeks
Creatinine clearance >= 30ml/min by Cockcroft-Gault formula
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if total bilirubin has been persistently > 1.5 x ULN for more than 2 weeks
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN or =< 5 x ULN if AST or ALT have been persistently > 3 x ULN for more than 2 weeks
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
Study participants with risk factors for venous thrombo-embolism (VTE), such as previous VTE, cardiac disease, chronic renal insufficiency, and/or poorly controlled diabetes, should be able to comply with some degree of prophylactic anticoagulation using aspirin 81 or 325 mg daily, coumadin, or low molecular weight heparin
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Sorror | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| rituximab | Biological | Given IV |
|
|
| pharmacological study | Other | Correlative studies |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Assessed up to 30 days after completion of study treatment |
| Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD | Assessed up to 30 days after completion of study treatment |
| Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts | Assessed up to 18 months |
| Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide | From baseline to day 28 of course 3 |
| Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts | Assessed up to 30 days after completion of study treatment |
| Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses | Baseline, day 7 and 28 of course 1, and day 28 of course 3 |
| Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse | Baseline, day 7 and 28 of course 1, and day 28 of course 3 |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Number | 95% Confidence Interval | survival probability | 12 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Rate of Response (CR, PR, or SD) and Time to Progression | Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100. | No participants enrolled in the second arm. | Posted | Number | 95% Confidence Interval | progression free survival probability | Assessed up to 18 months |
| ||||||||||||||||||||||||||||||
| Secondary | Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab | No participants enrolled in the second arm. | Posted | Count of Participants | Participants | Assessed up to 30 days after completion of study treatment |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD | No participants enrolled in the second arm. | Posted | Count of Participants | Participants | Assessed up to 30 days after completion of study treatment |
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Assessed up to 18 months |
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | From baseline to day 28 of course 3 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Incidences of Adverse Events 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. | Posted | Number | Number of adverse events | Assessed up to 30 days after completion of study treatment |
| ||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses | With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected. | Posted | Baseline, day 7 and 28 of course 1, and day 28 of course 3 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse | With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected. | Posted | Baseline, day 7 and 28 of course 1, and day 28 of course 3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 3 | 0 | 3 | ||
| EG001 | 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 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superior vena cava obstruction | Vascular disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Tumor flare syndrome | Metabolism and nutrition disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Rash >50% BSA | Skin and subcutaneous tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed Sorror | Fred Hutchinson Cancer Research Center | 206-667-6298 | msorror@fredhutch.org |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D064090 | Intraocular Lymphoma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D015463 | Leukemia, Prolymphocytic |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007943 | Leukemia, Hairy Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015458 | Leukemia, T-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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