View Clinical Trial (Medical Research Study)
A Phase II Randomized Study of Lenalidomide or Lenalidomide and Rituximab as Maintenance Therapy Following Standard Chemotherapy for Patients With High/High-intermediate Risk Diffuse Large B-Cell Lymphoma
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37064 |
| Conditions: |
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Lymphoma |
| Purpose: |
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RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the
cancer. It may also 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 cells to grow and spread. Others find cancer cells
and help kill them or carry cancer-killing substances to them. It is not yet known whether
lenalidomide is more effective with or without rituximab in treating diffuse large B-cell
non-Hodgkin lymphoma.
PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works
when given with or without rituximab after standard chemotherapy in treating patients with
diffuse large B-cell non-Hodgkin lymphoma.
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| Study Summary: |
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OBJECTIVES:
Primary
- To assess the 1-year disease-free and relapse-free survival of patients with high- or
high/intermediate-risk diffuse large B-cell non-Hodgkin lymphoma treated with
maintenance therapy comprising lenalidomide with or without rituximab following
standard chemotherapy.
Secondary
- To assess the 2-year disease-free survival of patients treated with these regimens.
- To define the safety and toxicity profile of these regimens.
- To perform antibody-dependent cellular cytotoxicity assays using peripheral blood
mononuclear cell samples from these patients.
- To assess the change in the number of natural killer cells by flow cytometric analysis.
- To evaluate cytokines including, but not limited to, sIL-2R, IL-6, IL-15, IL-12, TNF-α,
and IFN-γ in these patients.
- To study the KIR genotype receptor and FCγR polymorphisms.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats
every 28 days for 12 courses in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses
1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are collected periodically for correlative studies.
Samples are analyzed for change in the number of natural killer cells by flow cytometry;
antibody-dependent cellular cytotoxicity by assay; cytokines; KIR genotype receptor; and
FCγR polymorphisms.
After completion of study therapy, patients are followed at 30 days and then every 3 months
for 1 year.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma
- High- or high/intermediate-risk International Prognostic Index (IPI) score
- Low-risk IPI score meeting 1 of the following
- Score < 3 for age > 60 years
- Score < 2 for age ≤ 60 years with c-myc positive by Fluorescent In situ
Hybridization
- Achieved complete remission after standard front-line R-CHOP chemotherapy AND
completed therapy within the past 4-12 weeks
- Patients with PET scan-positive disease mid-therapy with front-line R-CHOP
chemotherapy are eligible provided PET scan is negative after completion of
therapy
- Patients with PET scan-positive, biopsy-confirmed persistent disease after
completion of front-line R-CHOP chemotherapy are eligible provided they are not
eligible for transplant
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN if hepatic
metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception for at least 28 days
before, during, and for at least 28 days after study treatment
- Able to adhere to the study visit schedule and other study requirements
- Able to take aspirin (81 or 325 mg/day) as prophylactic anticoagulation, if at
elevated risk of thrombosis
- No diagnosis of deep vein thromboses within the past 3 months
- No known hypersensitivity to thalidomide
- No development of erythema nodosum, if characterized by a desquamating rash, while
taking thalidomide or similar drugs
- No known HIV positivity
- No known hepatitis B or C infection
- No other malignancies within the past 3 years except treated basal cell or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- No serious medical condition, laboratory abnormality, or psychiatric illness that
would preclude giving informed consent or participating in the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other prior cancer therapy, including radiotherapy, hormonal therapy, or surgery
- No prior lenalidomide
- More than 28 days since prior experimental drug or therapy
- No other concurrent anticancer agents or treatments
- No other concurrent investigational agents
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| NCT ID: |
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NCT00765245 |
| Primary Contact: |
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Principal Investigator
Nishitha Reddy, MD
Vanderbilt-Ingram Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Nashville, Tennessee 37064
United States
VICC Clinical Trials Information Program
Phone: 800-811-8480
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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