NCT01612988

Treatment With Bendamustine, Ofatumumab and MethylPrednisolone in Relapsed B-CLL

Phase II Salvage Treatment With Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in Relapsed B-cell Chronic Lymphocytic Leukemia (B-CLL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

ICLL01 The BOMP trial: Phase II study of salvage treatment with Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL). A study of the GOELAMS / GCFLLC-MW intergroup

Detailed description

Available datas suggest that a combination of bendamustine, ofatumumab and high dose steroids (the BOMP regimen) appears meaningful and likely to induce a high response rate in patients with relapsed CLL, including those who have relapsed after modern 1st line immuno-chemotherapy combinations and those who are fludarabine-refractory. The BOMP trial will address the complete response rate as its main objective. The results of bendamustine and rituximab CLL2M trial will serve of a comparator for the BOMP trial. Among secondary objectives, an extensive study of the p53 pathway (deletion 17p, TP53 mutational status and p53 function) will be performed and its impact on response and survival will be analyzed.

Conditions

• B-cell Chronic Lymphocytic Leukemia (B-CLL)

Interventions

Type	Name	Description
DRUG	BOMP	Day-8 OMB prephase: Ofatumumab 300 mg IV day -8 Methylprednisolone 100 mg TD IV day -8 BOMP cycle 1 and 2 : Ofatumumab 1000 mg IV day 1 and day 15 Bendamustine 70mg IV day 2 and ady 3 Methylprednisolone 1000 mg/m² IV day 1, 2 and 3 Methylprednisolone 100 mg TD IV day 15 BOMP cycle 3 to 6 : Ofatumumab 1000 mg IV day 1 Bendamustine 70mg IV day 2 and day 3 Methylprednisolone 1000 mg/m² IV day 1, 2 and 3

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-12-01
• Completion: 2018-04-01
• First posted: 2012-06-06
• Last updated: 2018-04-27

Locations

1 site across 1 country: France