Status:
COMPLETED
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
Lead Sponsor:
University of Miami
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is stu...
Detailed Description
OBJECTIVES: Primary * Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate, doxorubicin, cyclophospha...
Eligibility Criteria
Inclusion
- Previously untreated, histologically confirmed mantle cell lymphoma.
- Measurable or evaluable disease.
- All stages are eligible.
- Age \> 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Adequate hepatic function:
- Bilirubin \< 3 mg/dL.
- Transaminases (SGOT and/or SGPT) \< than 2.5 times the upper limit of normal for the institution, unless due to lymphomatous involvement.
- Serum creatinine \< 1.5 mg/Dl.
- Ability to give informed consent.
- Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
- Life expectancy greater than 6 months.
Exclusion
- Previous chemotherapy, immunotherapy or radiotherapy for this lymphoma
- Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
- Grade 3 or 4 cardiac failure and/or ejection fraction \< 50.
- Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
- Patients with a known history of HIV or AIDS
- Presence of hepatitis or hepatitis B virus (HBV) infection
- Pregnant or breast-feeding women.
- Central nervous system (CNS) involvement
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00450801
Start Date
April 1 2004
End Date
July 1 2015
Last Update
November 10 2015
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136