Status:
COMPLETED
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Lead Sponsor:
University of Miami
Conditions:
Mantle-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and o...
Eligibility Criteria
Inclusion
- Previously untreated, histologically confirmed mantle cell lymphoma,
- Measurable or evaluable disease (at least one site with \>1.5 cm in diameter
- 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 (serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate-pyruvate transaminase (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 mantle cell 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 human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (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 :
March 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00878254
Start Date
March 25 2009
End Date
May 30 2025
Last Update
July 23 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33186