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Phase II Salvage Treatment With Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in Relapsed B-cell Chronic Lymphocytic Leukemia (B-CLL)

Phase 2
18 Years
80 Years
Open (Enrolling)
B-cell Chronic Lymphocytic Leukemia (B-CLL).

Thank you

Trial Information

Phase II Salvage Treatment With Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in Relapsed B-cell Chronic Lymphocytic Leukemia (B-CLL)

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.

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

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

- 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

- 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

- 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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: Response rate according to IWCLL 2008 guidelines

Outcome Description:

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

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

July 2012

Completion Date:

July 2019

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia (B-CLL).
  • B-cell chronic lymphocytic leukemia
  • relapse
  • Bendamustine
  • Ofatumumab
  • Méthylprednisolone
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid