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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Sponsor:
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT01612988
First received: May 30, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
B-cell Chronic Lymphocytic Leukemia (B-CLL).
Drug: BOMP
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • Efficacy: Response rate according to IWCLL 2008 guidelines [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Complete response rate (CR) at 6 cycles of BOMP according to IWCLL 2008 criteria Hallek 2008


Secondary Outcome Measures:
  • Tolerance and safety [ Time Frame: 57 months ] [ Designated as safety issue: Yes ]
    Tolerance and safety of the BOMP regimen according to the CTC criteria


Estimated Enrollment: 110
Study Start Date: July 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Other Name: BOMP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612988

Contacts
Contact: Olivier TOURNILHAC, MD PD +33 473 750 750 otournilhac@chu-clermont.fr
Contact: Sophie DE GUIBERT, MD +33 299 284 2 91 sophie.deguibert@chu-rennes.fr

Locations
France
Tournilhac Recruiting
Clermont Ferrand, France, 63000
Contact: Roselyne DELEPINE    +33247473798    r.delepine@chu-tours.fr   
Contact: Sophie DE GUIBERT, MD    +33 299284291    sophie.deguibert@xchu-rennes.fr   
Principal Investigator: Olivier TOURNILHAC, MD PD         
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Olivier TOURNILHAC, MD PD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Principal Investigator: Sophie DE GUIBERT, MD PD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT01612988     History of Changes
Other Study ID Numbers: ICLL01 BOMP
Study First Received: May 30, 2012
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
B-cell chronic lymphocytic leukemia
relapse
Bendamustine
Ofatumumab
Méthylprednisolone

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

ClinicalTrials.gov processed this record on September 14, 2014