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

NCT01612988 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2018-04-27

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Olivier TOURNILHAC, MD PD · French Innovative Leukemia Organisation

  • Sophie DE GUIBERT, MD PD · French Innovative Leukemia Organisation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-12-31
Completion
2018-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612988 on ClinicalTrials.gov