drugset / Trial / NCT01502982

Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)

NCT01502982 ↗

Phase 2 Completed 160 enrolled Nordic Lymphoma Group Amgen · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could improve time to treatment failure and reduce the risk of CNS relapses. Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be compared to a historical Nordic study.

Timeline

Start
2004-11
Primary completion
2013-12
Completion
2014-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2 —
Subject Cytarabine Small molecule 3 g Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 —
Subject Etoposide Small molecule 100 mg/m2 —
Subject Methotrexate Small molecule 3 g Intravenous
Subject Prednisone Other / unclassified 100 mg —
Subject Rituximab Monoclonal antibody 375 mg/m2 —
Subject Vincristine Small molecule 1.4 mg/m2 —