Phase II salvage treatment with Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL).

ICLL01 BOMP Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002307-14-FR

Enrollment

115

Registered

2011-12-15

Start date

2013-04-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed B-cell chronic lymphocytic leukemia (B-CLL). MedDRA version: 14.1 Level: LLT Classification code 10003946 Term: B-Lymphocytic, CLL (Kiel Classification) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Chlorhydrate de bendamustine Product Name: LEVACT 2,5 mg/ml powder for infusion Pharmaceutical Form: Powder for infusion INN or Proposed IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age superior to 18 years old and inferior to 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 with fludarabine 5. ECOG Performans status and general condition. • ECOG Performance status = 2 • Fit Patients : CIRS Cumulative Illness Rating Scale) ? 6 • Life expectancy of more than 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: - Response rate (ORR, CR, PR) at 6 cycles of BOMP according to IWCLL 2008 guidelines ;Primary end point(s): - Response rate (ORR, CR, PR) at 6 cycles of BOMP according to IWCLL 2008 guidelines ;Timepoint(s) of evaluation of this end point: 10-12 weeks after the day one of the 6th cycle of BOMP.; Secondary Objective: - Tolerance and safety of the BOMP regimen according to the CTC criteria - Rate of achievement of a negative minimal residual disease (MRD) at 6 cycles of BOMP - Survival including progression free survival (PFS), event free Survival (EFS), overall Survival (OS) and time to next treatment (TTNT) - Impact of P53 mutation status/function/expression on response and survival	—

Measure

Time frame

Main Objective: - Response rate (ORR, CR, PR) at 6 cycles of BOMP according to IWCLL 2008 guidelines ;Primary end point(s): - Response rate (ORR, CR, PR) at 6 cycles of BOMP according to IWCLL 2008 guidelines ;Timepoint(s) of evaluation of this end point: 10-12 weeks after the day one of the 6th cycle of BOMP.; Secondary Objective: - Tolerance and safety of the BOMP regimen according to the CTC criteria - Rate of achievement of a negative minimal residual disease (MRD) at 6 cycles of BOMP - Survival including progression free survival (PFS), event free Survival (EFS), overall Survival (OS) and time to next treatment (TTNT) - Impact of P53 mutation status/function/expression on response and survival

—

Secondary

Measure	Time frame
Secondary end point(s): - Tolerance and safety of the BOMP regimen according to the CTC criteria - Rate of achievement of a negative minimal residual disease (MRD) at 6 cycles of BOMP - Survival including progression free survival (PFS), event free Survival (EFS), overall Survival (OS) and time to next treatment (TTNT) - Impact of P53 mutation status/function/expression on response and survival ;Timepoint(s) of evaluation of this end point: end of study treatment + 3 years Follow up	—

Measure

Time frame

Secondary end point(s): - Tolerance and safety of the BOMP regimen according to the CTC criteria - Rate of achievement of a negative minimal residual disease (MRD) at 6 cycles of BOMP - Survival including progression free survival (PFS), event free Survival (EFS), overall Survival (OS) and time to next treatment (TTNT) - Impact of P53 mutation status/function/expression on response and survival ;Timepoint(s) of evaluation of this end point: end of study treatment + 3 years Follow up

—

Countries

France

Contacts

Public ContactDELEPINE Roselyne

Groupe Est Ouest des Leucémies et Autres Maladies du Sang

r.delepine@chu-tours.fr+33247 47 37 98

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026