Status:
COMPLETED
Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: 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 ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of lenalidomide when given in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in pa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large cell or grade 3A/B follicular lymphoma
- Newly diagnosed disease
- Stage II, III, or IV disease
- Measurable disease, defined as ≥ 1 lesion ≥ 1.5 cm in one diameter, as detected by CT scan or PET-CT scan (PET/CT fusion)
- CD20-positive disease
- No post-transplant lymphoproliferative disorder (PTLD)
- No CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
- Alkaline phosphatase ≤ 3 times ULN (5 times ULN if direct liver involvement by lymphoma)
- AST ≤ 3 times ULN (5 times ULN if direct liver involvement by lymphoma)
- Creatinine ≤ 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
- Fertile male patients must use effective contraception during and for ≥ 28 days after completion of study therapy, even if they have had a successful vasectomy
- No blood, sperm, or semen donation during and for ≥ 28 days after completion of study therapy
- Willing to return to enrolling institution for follow-up
- Willing to provide blood samples for translational research purposes
- No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with the proper assessment of safety and toxicity of the prescribed study regimen
- No known HIV positivity
- Not immunocompromised
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situation that would preclude compliance with study requirements
- No other active malignancy, except localized nonmelanotic skin cancer or any cancer that, in the judgment of the investigator, has been treated with curative intent and will not interfere with the study treatment plan and response assessment
- No myocardial infarction within the past 6 months
- No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Ejection fraction ≥ 45% by MUGA or ECHO
- No history of life threatening or recurrent thrombosis/embolism (unless on anticoagulation therapy during study treatment)
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to ≥ 25% of the bone marrow
- No concurrent erythroid-stimulating agents (e.g., Procrit, Aranesp)
- No other concurrent treatment for lymphoma
- No concurrent radiotherapy, chemotherapy, or immunotherapy for another active malignancy
- Able to receive concurrent prophylactic anticoagulation therapy (e.g., low-dose aspirin \[81 mg\] daily or an alternative prophylaxis \[e.g., warfarin or low molecular weight heparin\])
Exclusion
Key Trial Info
Start Date :
August 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00670358
Start Date
August 25 2008
End Date
October 4 2024
Last Update
January 10 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic
Rochester, Minnesota, United States, 55905