drugset
drugset / Trial / NCT01481272

Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

NCT01481272 ↗

Phase 2 Completed 77 enrolled Polish Lymphoma Research Group
NaSingle-groupOpen-labelTreatment

Summary

It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous Stem Cell Transplant (ASCT).

Timeline

Start
2011-11
Primary completion
2017-07
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 1000 unknown Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 200 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 300 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 600 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 900 mg/m2 Intravenous
Background Cytarabine Small molecule 500 mg/m2 Intravenous
Background Cytarabine Small molecule 1000 mg/m2 Intravenous
Background Cytarabine Small molecule 2000 mg/m2 Intravenous
Background Etoposide Small molecule 60 mg/m2 Intravenous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 5 ug/kg Subcutaneous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 263 ug Subcutaneous
Background Ifosfamid Unknown 1000 mg/m2 Intravenous
Background Ifosfamid Unknown 1500 mg/m2 Intravenous
Background Leucovorin Small molecule 15 mg Oral
Background Methotrexate Small molecule 12 mg Intrathecal

Indications

diffuse large B-cell lymphoma