A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory
| City: |
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Normal |
| State: |
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Illinois |
| Zip Code: |
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61761 |
| Conditions: |
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Lymphoma |
| Purpose: |
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RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells
and help kill them or carry cancer-killing substances to them. Biological therapies, such as
lenalidomide, may stimulate the immune system in different ways and stop cancer cells from
growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood
flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well rituximab and/or lenalidomide
work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to
rituximab.
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| Study Summary: |
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OBJECTIVES:
Primary
- Compare the overall and complete response rate in patients with follicular
non-Hodgkin's lymphoma that has relapsed after treatment with rituximab and/or
lenalidomide.
- Compare time to progression (TTP) in patients treated with these regimens.
Secondary
- Compare TTP after prior rituximab-based combination therapy vs TTP in patients treated
with these regimens.
- Determine the toxicity profile of these regimens in these patients.
- Correlate Fc-receptor-polymorphism profiling with response in patients treated with
these regimens.
- Correlate changes in natural killer (NK) cells, activated NK cells, activated T-cells,
and several plasma cytokines after exposure to lenalidomide therapy, followed by
rituximab, with objective response rate in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3
treatment arms.
- Arm I (closed to accrual as of 9/15/07): Patients receive rituximab IV on days 1, 8,
15, and 22.
- Arm II: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.
- Arm III: Patients receive lenalidomide as in arm II. Patients also receive rituximab IV
on days 8, 15, and 22 of course 1 and day 1 of course 2 of lenalidomide.
After completion of study treatment, patients are followed for up to 10 years from study
entry.
PROJECTED ACCRUAL: A total of 180 patients (90 for arm I [closed to accrual as of 9/15/07],
45 each for arms II and III) will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically* confirmed follicular non-Hodgkin's lymphoma
- Grade 1, 2, or 3a disease (> 15 centroblasts per high-power field with
centrocytes present) NOTE: *Bone marrow biopsy as the sole means of diagnosis is
not acceptable; fine-needle aspirates are not acceptable
- Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry
- Measurable disease > 1 cm
- No non-measurable disease only, including any of the following:
- Bone lesions
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow involvement
- Must have been treated with rituximab either alone or in combination with
chemotherapy
- Time to disease progression ≥ 6 months after last rituximab dose
- Last prior treatment regimen need not include rituximab
- No known CNS involvement
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or
lymphoma)
Renal
- Creatinine < 1.5 times ULN (unless due to lymphoma) OR creatinine clearance > 30
mL/minute (patients on dialysis not allowed)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No "currently active" secondary malignancy (e.g., Waldenstrom's macroglobulinemia)
except nonmelanoma skin cancer
- Patients are not considered to have a "currently active" second malignancy if
they have completed anticancer therapy and are deemed to have < 30% risk of
relapse by their physician
- No deep vein thrombosis or pulmonary embolism within the past 3 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- See Radiotherapy
Chemotherapy
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy
- More than 2 weeks since prior corticosteroids except for maintenance therapy (at a
dose ≤ 20 mg/day) for a nonmalignant disease
- No concurrent hormonal therapy except for the following:
- Steroids for adrenal failure
- Hormones for non-disease-related conditions (e.g., insulin for diabetes)
- No concurrent dexamethasone or other steroids as antiemetics
- Concurrent dexamethasone for infusion reactions allowed
Radiotherapy
- No radioimmunotherapy within 12 months of study entry
Other
- No other concurrent investigational or commercial agents or therapies for lymphoma
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| NCT ID: |
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NCT00238238 |
| Primary Contact: |
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Study Chair
John P. Leonard, MD
Weill Medical College of Cornell University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Normal, Illinois 61761
United States
John W. Kugler, MD
Phone: 309-243-3605
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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