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

NCT01612988 | Terminated Phase 2 DMC

• 1 other identifier: ICLL01 BOMP
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

B-cell Chronic Lymphocytic Leukemia (B-CLL)

Keywords

B-cell chronic lymphocytic leukemia; relapse; Bendamustine; Ofatumumab; Méthylprednisolone

Outcome Measures

Primary Outcomes (1)

• Efficacy: Response rate according to IWCLL 2008 guidelines

  Complete response rate (CR) at 6 cycles of BOMP according to IWCLL 2008 criteria Hallek 2008

  9 months

Secondary Outcomes (1)

• Tolerance and safety

  57 months

Study Arms (1)

Chemotherapy BOMP

EXPERIMENTAL

Bendamustine, Ofatumumab and Methylprednisolone prephase and a maximum of 6 cycles every 4 weeks

Drug: BOMP

Interventions

BOMP DRUG

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

Chemotherapy BOMP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

Study Sites (1)

Tournilhac

Clermont-Ferrand, 63000, France

Location

Related Links

• FILO Internet site

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier TOURNILHAC, MD PD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

• Sophie DE GUIBERT, MD PD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 6, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

FR (1)