R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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 studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Etoposide; Etoposide phosphate; Granisetron; Ifosfamide; Isophosphamide mustard; Leucovorin; Liposomal doxorubicin; Mesna; Methotrexate; Rituximab; Thalidomide; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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