Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 overall survival in patients with previously untreated Mantle Cell
Lymphoma (MCL).
Phase
Phase 2
Funding Agency/Sponsor
Institutional
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria:
1. Previously untreated, histologically confirmed mantle cell lymphoma,
2. Measurable or evaluable disease (at least one site with >1.5 cm in diameter
3. All stages are eligible
4. Age > 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
6. 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
7. Serum creatinine< 1.5 mg/dl
8. Ability to give informed consent
9. 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.
10. Life expectancy greater than 6 months.
Exclusion Criteria:
1. Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
2. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix
and basal cell carcinoma of the skin.
3. Grade 3 or 4 cardiac failure and/or ejection fraction < 50.
4. Psychological, familial, sociological or geographical conditions that do not permit
treatment and/or medical follow-up required to comply with the study protocol.
5. Patients with a known history of human immunodeficiency virus (HIV) or Acquired
Immunodeficiency Syndrome (AIDS).
6. Presence of hepatitis or hepatitis B virus (HBV) infection.
7. Pregnant or breast-feeding women.
8. Central Nervous System (CNS) involvement.