drugset
drugset / Trial / NCT02419469

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

NCT02419469 ↗

Phase 2 Terminated 1 enrolled M.D. Anderson Cancer Center Jazz Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if a chemotherapy combination called augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab, can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety of these drug combinations will also be studied. Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG asparaginase, and methotrexate.

Timeline

Start
2015-11-13
Primary completion
2017-06-22
Completion
2017-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 1 g Intravenous
Subject Cytarabine Small molecule 75 mg/m2 Intrathecal
Subject Cytarabine Small molecule 100 mg Intrathecal
Subject Daunorubicin Small molecule 25 mg/m2 Intravenous
Subject Dexamethasone Small molecule 6 mg/m2 Oral
Subject Dexamethasone Small molecule 10 mg/m2 Oral
Subject Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Subject MERCAPTOPURINE ANHYDROUS Small molecule 60 mg/m2 Oral
Subject MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2 Oral
Subject Methotrexate Small molecule 12 mg Intrathecal
Subject Methotrexate Small molecule 20 mg/m2 Intrathecal
Subject Methotrexate Small molecule 100 mg/m2 Intrathecal
Subject Ofatumumab Monoclonal antibody 300 mg Intravenous
Subject Ofatumumab Monoclonal antibody 2000 mg Intravenous
Subject Pegaspargase Protein / enzyme biologic 2000 iu Intravenous
Subject Prednisone Other / unclassified 60 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Thioguanine Small molecule 60 mg/m2 Oral
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous

Indications

lymphoblastic lymphoma precursor B-cell acute lymphoblastic leukemia