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B-cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2BOMPNCT01612988

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

A Phase 2 study testing BOMP in people with B-cell Chronic Lymphocytic Leukemia (B-CLL), run by French Innovative Leukemia Organisation at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
BOMP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteFrance
Study dates
Jul 2012to Apr 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Tournilhac

    Clermont-Ferrand, 63000

Other trials in France

About this study

Official title: 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

Read the 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.

Being tested
BOMP
Keywords
B-cell chronic lymphocytic leukemia, relapse, Bendamustine, Ofatumumab, Méthylprednisolone
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOMPDrug

    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

Study groups in NCT01612988
Study groupRoleWhat they receive
Chemotherapy BOMPExperimentalBendamustine, Ofatumumab and Methylprednisolone prephase and a maximum of 6 cycles every 4 weeks
Receives: Drug: BOMP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 9 months

Secondary outcomes (1)

  1. Tolerance and safety

    Tolerance and safety of the BOMP regimen according to the CTC criteria

    Measured: 57 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2015
  4. Study completionApr 2018

Why it stopped: Other drugs others studies

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01612988
Sponsor's protocol ID
ICLL01 BOMP
Acronym
BOMP
Status last verified
Apr 2018
First submitted
30 May 2012
Last updated
27 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOMP in people with B-cell Chronic Lymphocytic Leukemia (B-CLL), run by French Innovative Leukemia Organisation at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Other drugs others studies). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Response rate according to IWCLL 2008 guidelines (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01612988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.

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