- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612988
Treatment With Bendamustine, Ofatumumab and MethylPrednisolone in Relapsed B-CLL (BOMP)
Phase II Salvage Treatment With Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in Relapsed B-cell Chronic Lymphocytic Leukemia (B-CLL)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Clermont Ferrand, France, 63000
- Tournilhac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >18 years and < 80 years
- Diagnosis of CLL according IWCLL 2008 criteria and fulfilling a Matutes- Moreau score ≥ 4
- Relapsed or refractory CLL stage A, B or C with active disease requiring therapy according to IWCLL 2008 criteria
- Relapse or refractory after 1 to 3 previous lines including at least one line with fludarabine
ECOG Performance status and general condition.
- ECOG Performance status ≤ 2
- Fit Patients : CIRS (Cumulative Illness Rating Scale) less or equal 6
- Life expectancy of more than 3 months
Note : Patients fulfilling the above inclusion criteria and presenting with the following features can also be included:
- patients with any rate of 17p deletion by FISH
- patients candidate for an allogeneic transplantation, provided these patients will be planned to receive the full BOMP treatment program and will have the final restaging assessment
- patients with fludarabine refractory disease
- patients with a prior diagnostic of CLL, at time of previous line(s) of treatment but who relapse without hyperlymphocytosis (lymphocytes < 5000/mm3) (lymphocytic lymphoma)
- prior monoclonal antibody (alemtuzumab or rituximab) exposure provided a washout period of 3 months before the start of the BOMP treatment.
Exclusion Criteria:
- Untreated CLL
- ECOG Performance Status > 2
Serious accompanying disorder or impaired organ function as indicated by:
- Abnormal renal function with creatinine clearance < 40 ml/min calculated according to the formula of Cockcroft and Gault
- Absolute neutrophils <1,000/mm3, platelets < 75000/mm3 (unless due to malignant B Cell involvement of the bone marrow and/or spleen enlargement)
- Liver tests : total bilirubin >1.5 times UNL (unless due to CLL involvement of liver or a known history of Gilbert's disease), transaminases (ALAT, ASAT) and/or alkaline phosphatases >2.5 times UNL (unless due to CLL involvement of liver)
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to study enrollment, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- Severe chronic obstructive pulmonary disease with hypoxemia or pulmonary diffusion capacity < 40 %
- Uncontrolled diabetes mellitus,
- Uncontrolled hypertension
- History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
- CIRS (Cumulative Illness Rating Scale) > 6
- Clinically significant auto-immune anemia [i.e. any drop in hemogolobin level related to an hemolytic autoimmune process attested by the following markers : elevated indirect bilirubin, elevated LDH, low haptoglobin levels, high reticulocytes count along with a positive direct anti-erythrocyte test (Coombs direct test)]
- Transformation to an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin's lymphoma, or prolymphocytic leukaemia)
- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy.
- Prior autologous transplantation or allogeneic transplantation
- Prior treatment with bendamustine and/or ofatumumab
- Active second malignancy currently requiring treatment (except basal cell carcinoma, in situ cervix carcinoma and incidental prostate carcinoma). Subjects who have been free of malignancy for at least 5 years are eligible.
- Known HIV-positivity
- Positive serology for hepatitis B (HB) (except post vaccinale pattern) and/or for hepatitis C. Positive serology for HB is defined as a positive test for HBs antigen or for anti-HBc antibodies (regardless of HBsAb status).
- Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)
- Simultaneous participation in another study protocol
- Known hypersensitivity to the medications to be used specially to humanized monoclonal antibodies or any of the study drugs
- Chronic or current bacterial, viral or fungal infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis
- Any coexisting medical or psychological condition that would preclude participation in the required study procedures
- Patient with mental deficiency preventing proper understanding of the requirements of treatment.
- Pregnant or breastfeeding women.
- Person major under law-control
- Lactating women
- Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy BOMP
Bendamustine, Ofatumumab and Methylprednisolone prephase and a maximum of 6 cycles every 4 weeks
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Response rate according to IWCLL 2008 guidelines
Time Frame: 9 months
|
Complete response rate (CR) at 6 cycles of BOMP according to IWCLL 2008 criteria Hallek 2008
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance and safety
Time Frame: 57 months
|
Tolerance and safety of the BOMP regimen according to the CTC criteria
|
57 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olivier TOURNILHAC, MD PD, French Innovative Leukemia Organisation
- Principal Investigator: Sophie DE GUIBERT, MD PD, French Innovative Leukemia Organisation
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICLL01 BOMP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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