NCT01481272

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

A Phase II Trial on Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients Progressing or Relapsed After Prior R-CHOP Treatment Not Suitable for Autologous Stem Cell Transplant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Polish Lymphoma Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is to assess the Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR) in adult Diffuse Large B Cell Lymphoma (DLBCL) patients progressing or relapsed after prior R-CHOP treatment not suitable for ASCT treated with O-IVAC salvage chemotherapy regimen. The secondary objective is the evaluation of progression-free survival (PFS), event-free survival (EFS), overall survival (OS), safety and tolerability.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ofatumumab	1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
DRUG	Etoposide	60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles
DRUG	Ifosfamid	1500mg/m2 or 1000mg/m2 (patients \>/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles
DRUG	Mesna	300mg/m2 or 200mg/m2 (patients \>/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients \>/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles
DRUG	Cytarabine	2g/m2 or 0,5-1g/m2 (patients \>/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles
DRUG	Methotrexate	12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
DRUG	Leukovorin	15mg, po 24 hours after methotrexate it
DRUG	Granulocyte-Colony Stimulating Factor	5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l

Timeline

• Start date: 2011-11-01
• Primary completion: 2017-07-01
• Completion: 2018-12-01
• First posted: 2011-11-29
• Last updated: 2021-12-27

Locations

8 sites across 1 country: Poland