A Phase 2 interventional study of BeEAM in Follicular Lymphoma, sponsored by Centre Leon Berard. Terminated at 13 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by Centre Leon Berard · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine, etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma (World Health Organisation (WHO) grade 1, 2, 3a).
The natural history of this follicular lymphoma (FL) is marked by multiple relapses. The prognosis of FL has improved with the use of effective sequential chemotherapy and the introduction of anti-cluster of differentiation antigen 20 (anti-CD20) monoclonal antibody. Based on the multiple phases II, high dose chemotherapy (HDT) followed by autologous stem cell transplantation (ASCT) appear to be an effective treatment in relapsed FL. At rituximab era, the 3-years EFS rate was 75% for relapsed transplanted patients treated in first line therapy in FL2000 protocol. Bendamustine that combines alkylating and antimetabolite activities had proven clinical activity in relapse and in first line therapy of FL. Carmustine (BCNU), etoposide, cytarabine, and melphalan (BEAM regimen) is one of the most used schedule of HDT in non hodgkin lymphoma. Regarding the good safety profile of Bendamustine, Visani et al. proposed a phase I/II of bendamustine at day -7 and -6, followed by etoposide, cytarabine and melphalan with similar dose than BEAM regimen. The bendamustine maximal dose is 200 mg/m² day -7, -6. Data from engraftment showed closed results than those observed after BEAM. None of patients experienced a dose limiting toxicity. In this context, the investigators proposed to perform a multicentric phase II of this regimen with 200 mg/m² day-7 and -6 of bendamustine for first and second relapsed FL with a chemosensitive disease after salvage therapy. No FL was evaluated in Visani et al. study. In addition, the investigators can observe a shortage of the BCNU these last years that incline to evaluate new schedule of HDT.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.
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Normal organ and marrow function as defined below:
Women of childbearing potential* and men must agree to use adequate contraception prior to study entry, for the duration of study participation and until 6 months after the end of treatment
EXCLUSION CRITERIA:
High Dose Chemotherapy (HDT) containing : * Bendamustine * Etoposide * Cytarabine * Melphalan HDT will be followed by an Autologous Stem Cell Transplantation
Drug: BeEAM
High Dose Chemotherapy (HDT) containing : * Bendamustine 160 mg/m2 for 2 days (D-8 and D-7) * Etoposide 200 mg/m2 and Cytarabine 400 mg/m2 for 4 days (D-6 to D-3) * Melphalan 140 mg/m2 on D-2 HDT will be followed by an Autologous Stem Cell Transplantation on D0
Also known as: Bendamustine, Etoposide, Cytarabine, Melphalan
Event Free Survival rate (EFS)
EFS will be measured from the date of inclusion to the date of event defined as : death due to any cause, relapse/progression, or changes in therapies. Patients with no event at the time of analysis will be censored at the date of the last contact
Time frame: Evaluated by the time from inclusion to the time of event appearance with a time of observation of 2 years after inclusion
Safety profile of BeEAM
The safety analyzable population include all patients who received at least one dose of BeEAM regimen
Time frame: Evaluated all along the 4 years study follow up for each patient
Overall Response Rate (ORR) according to Cheson at al. 2007
ORR is defined by the rate of patients in Complete Response (CR) and in Partial Response (PR) at time of evaluation. ORR is assessed according to Cheson et al. 2007 criteria
Time frame: Evaluated at day 100 after graft
Overall Response Rate (ORR) according to Cheson et al. 1999
ORR is defined by the rate of patients in Complete Response (CR) and in Partial Response (PR) at time of evaluation. ORR assessed according to Cheson et al. 1999 criteria
Time frame: Evaluated at day 100 after graft
Progression Free Survival (PFS)
PFS will be measured from the date of inclusion to the date of event defined as : progression/relapse or death due to any cause. Patients with no event at the time of analysis will be censored at the date of the last contact. PFS will be assessed among all included patients and in the subgroup of complete responders at the beginning of HDT.
Time frame: Evaluated by the time from inclusion to the time of progression with a study duration of 5 years maximum
Overall Survival (OS)
OS will be measured from the date of inclusion to the date of death due to any cause and will be censored at the date of last contact for the patients alive at last contact
Time frame: Evaluated by the time from inclusion to the time of death with a study duration of 5 years maximum
Plan to share: No
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Centre Leon Berard