drugset / Trial / NCT00878254

Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma

NCT00878254

Phase 2 Completed 25 enrolled University of Miami
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2009-03-25
Primary completion
2024-06-28
Completion
2025-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 200 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 800 mg/m2 Intravenous
Subject Cytarabine Small molecule 2 g Intravenous
Subject Doxorubicin Other / unclassified 45 mg/m2 Intravenous
Subject Etoposide Small molecule 60 mg/m2 Intravenous
Subject Ifosfamide Small molecule 1.5 g Intravenous
Subject Methotrexate Small molecule 1200 mg/m2 Intravenous
Subject Methotrexate Small molecule 3000 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 360 mg/m2 Intravenous
Background G-CSF Unknown 480 ug Subcutaneous
Background Leucovorin Small molecule 10 mg/m2 Intravenous
Background Leucovorin Small molecule 100 mg/m2 Intravenous

Indications