drugset / Trial / NCT01854372

Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement.

NCT01854372

NaSingle-groupOpen-labelTreatment

Summary

To estimate the I-year progression-free survival probability in patients up to 70 years of age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with alternating cycles of Rituximab-HCV AD and Rituximab-Methotrexate-Cytarabine, in concert with optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and close clinical follow-up.

Timeline

Start
2013-06
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 300 mg/m2
Subject Cytarabine Small molecule 100 mg
Subject Cytarabine Small molecule 3000 mg/m2
Subject Dexamethasone Small molecule 40 mg
Subject Doxorubicin Other / unclassified 50 mg/m2
Subject Methotrexate Small molecule 12 mg
Subject Methotrexate Small molecule 200 mg/m2
Subject Methotrexate Small molecule 800 mg/m2
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject Vincristine Small molecule 2 mg
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 600 mg/m2
Background Leucovorin Small molecule 15 mg
Background Leucovorin Small molecule 50 mg