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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612988
Recruitment Status : Terminated (Other drugs others studies)
First Posted : June 6, 2012
Last Update Posted : April 27, 2018
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

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

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia (B-CLL) Drug: BOMP Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Salvage Treatment With Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in Relapsed B-cell Chronic Lymphocytic Leukemia (B-CLL)
Actual Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Chemotherapy BOMP
Bendamustine, Ofatumumab and Methylprednisolone prephase and a maximum of 6 cycles every 4 weeks
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Tolerance and safety [ Time Frame: 57 months ]
    Tolerance and safety of the BOMP regimen according to the CTC criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >18 years and < 80 years
  2. Diagnosis of CLL according IWCLL 2008 criteria and fulfilling a Matutes- Moreau score ≥ 4
  3. Relapsed or refractory CLL stage A, B or C with active disease requiring therapy according to IWCLL 2008 criteria
  4. Relapse or refractory after 1 to 3 previous lines including at least one line with fludarabine
  5. 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:

  1. Untreated CLL
  2. ECOG Performance Status > 2
  3. 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.
  4. CIRS (Cumulative Illness Rating Scale) > 6
  5. 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)]
  6. Transformation to an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin's lymphoma, or prolymphocytic leukaemia)
  7. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy.
  8. Prior autologous transplantation or allogeneic transplantation
  9. Prior treatment with bendamustine and/or ofatumumab
  10. 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.
  11. Known HIV-positivity
  12. 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).
  13. Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)
  14. Simultaneous participation in another study protocol
  15. Known hypersensitivity to the medications to be used specially to humanized monoclonal antibodies or any of the study drugs
  16. 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
  17. Any coexisting medical or psychological condition that would preclude participation in the required study procedures
  18. Patient with mental deficiency preventing proper understanding of the requirements of treatment.
  19. Pregnant or breastfeeding women.
  20. Person major under law-control
  21. Lactating women
  22. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612988

Clermont Ferrand, France, 63000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: Olivier TOURNILHAC, MD PD French Innovative Leukemia Organisation
Principal Investigator: Sophie DE GUIBERT, MD PD French Innovative Leukemia Organisation

Additional Information:
Responsible Party: French Innovative Leukemia Organisation Identifier: NCT01612988     History of Changes
Other Study ID Numbers: ICLL01 BOMP
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by French Innovative Leukemia Organisation:
B-cell chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Bendamustine Hydrochloride
Antibodies, Monoclonal
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents