Spots Global Cancer Trial Database for Treatment With Bendamustine, Ofatumumab and MethylPrednisolone in Relapsed B-CLL

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT01612988

Conditions

B-cell Chronic Lymphocytic Leukemia (B-CLL)

Interventions

BOMP

Study Description

Brief 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.