GIMEMA CLL0809 Study (BendOfa) (BendOfa)
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|ClinicalTrials.gov Identifier: NCT01244451|
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
In the last ten years there have been significant developments in CLL treatment. The advent of fludarabine, rituximab and the association of chemo-immunotherapy have substantially increased overall response rate, CR rate, time to progression and may also have an impact on overall survival.
Even though, CLL remains incurable and all patients eventually relapse and progressively become resistant to treatment. The development of an effective therapy that is not cross-resistant with the ones currently available as front-line treatment, is one of the clinical unmet needs within CLL.
BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.
Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating agents and purine analogue properties that may lack of cross resistance with fludarabine. It was utilized in CLL as a single agent and its association with rituximab is currently under clinical investigation.
Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is effective in highly pre-treated refractory CLL patients.
Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis of these data, bendamustine and ofatumumab could be a new effective and well tolerated combination for patients with relapsed and refractory CLL.
|Condition or disease||Intervention/treatment||Phase|
|Patients With CLL Relapsing After an Initial Response (CR, PR ≥ 6 Months) Following no More Than Two Prior Treatment Lines; or Patients With CLL Refractory (SD, PD or CR/PR < 6 Months) Following no More Than Two Prior Treatment Lines||Drug: Ofatumumab Drug: Bendamustine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Multi-Center Trial of Bendamustine Given With Ofatumumab (BendOfa) in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia (CLL). EudraCT Number 2009-017663-42. GIMEMA CLL0809 Protocol|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Bendamustine + Ofatumumab
Ofatumumab will be administered at the dose of 300 mg IV D1 and 1000 mg IV D8 1st course; 1000 mg IV D1, 2nd -6th courses.
Bendamustine will be infused at the doses of 70 mg/m2 IV on days D1 and D2 of each course.
- Number of Participants Contributing to the Overall Response Rate [ Time Frame: After 8 months from therapy start (6 months of treatment plus 2 months from the last course to response evaluation) ]Patients response to treatment will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.
- Toxicity According to CTCAE Version 4.0 [ Time Frame: At 44 months from treatment start. ]Number of patients experiencing 3 or >3 AEs (both hematological and not hematological)
- Progression Free Survival [ Time Frame: Up to 32 months: from the date of first BendOfa treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first. ]Patients still alive and known to be progression-free will be censored at the moment of last follow-up. Patients disease progression will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.
- Overall Survival [ Time Frame: At 44 months from treatment start. ]Patients still alive will be censored at the moment of last follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244451
|Principal Investigator:||Agostino Cortelezzi, Pr.||Direzione Scientifica - Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena|