A Phase 2 interventional study of lenalidomide and rituximab in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-27.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
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.
391 studies on the registry are indexed under Burkitt Lymphoma; 113 are open to participants now.
This study's enrollment of 3 is below the median of 41 across 353 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with CLL/SLL/PLL or NHL and who:
Exclusion Criteria:
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.
Drug: lenalidomide · Biological: rituximab · Other: pharmacological study · Other: laboratory biomarker analysis
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.
Drug: lenalidomide · Other: pharmacological study · Other: laboratory biomarker analysis
Given PO
Also known as: CC-5013, IMiD-1, Revlimid
Given IV
Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Correlative studies
Also known as: pharmacological studies
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)
Estimated using the Kaplan-Meier method in all cohorts.
Time frame: 12 months
Rate of Response (CR, PR, or SD) and Time to Progression
Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
Time frame: Assessed up to 18 months
Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
Time frame: Assessed up to 30 days after completion of study treatment
Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
Time frame: 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
Time frame: Assessed up to 18 months
Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
Time frame: From baseline to day 28 of course 3
Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
Time frame: 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
Time frame: 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
Time frame: Baseline, day 7 and 28 of course 1, and day 28 of course 3
| Milestone | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Started | 3 | 0 |
| Completed | 3 | 0 |
| Not completed | 0 | 0 |
Estimated using the Kaplan-Meier method in all cohorts.
| survival probability | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| 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 (0.067 to 1.00) | — |
Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
| progression free survival probability | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Rate of Response (CR, PR, or SD) and Time to Progression | 0.67 (0.30 to 1.00) | — |
| Participants | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab | 2 | — |
| Participants | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD | 0 | — |
| Participants | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts | 0 | — |
No measurements were reported for this outcome.
| Number of adverse events | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts | 7 | — |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Lenalidomide, Rituximab) | — | 2/3 (66.7%) | 0/3 (0%) |
| Arm II (Lenalidomide) | — | — | — |
| Event | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) |
|---|---|---|
| Superior vena cava obstructionVascular disorders | 1/3 | — |
| HyperglycemiaMetabolism and nutrition disorders | 1/3 | — |
| DehydrationMetabolism and nutrition disorders | 1/3 | — |
| Tumor flare syndromeMetabolism and nutrition disorders | 1/3 | — |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/3 | — |
| NeutropeniaBlood and lymphatic system disorders | 1/3 | — |
| Rash >50% BSASkin and subcutaneous tissue disorders | 1/3 | — |
| Age, Continuous(years) | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) | Total |
|---|---|---|---|
| Median | 57 (48 to 62) | — | 57 (48 to 62) |
| Sex: Female, Male(Participants) | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 2 | — | 2 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 0 | — | 0 |
| Unknown or Not Reported | 3 | — | 3 |
| Race (NIH/OMB)(Participants) | Arm I (Lenalidomide, Rituximab) | Arm II (Lenalidomide) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 0 | — | 0 |
| White | 3 | — | 3 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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