Neoplasms

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Melphalan

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Alkylating Agents

High Dose Chemotherapy (HDT) containing :

* Bendamustine
* Etoposide
* Cytarabine
* Melphalan

HDT will be followed by an Autologous Stem Cell Transplantation

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

BeEAM

Hervé Ghesquières, Dr

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.

BENdamustine at Elevated Dose for Relapsed Follicular Lymphoma in Intensification Therapy and Transplantation (BENEFIT)

A Multicenter Phase II Study Evaluating BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Prior to Autologous Stem Cell Transplant for First and Second Chemosensitive Relapses in Patients With Follicular Lymphoma

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

The safety analyzable population include all patients who received at least one dose of BeEAM regimen

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

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

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BENdamustine at Elevated Dose for Relapsed Follicular Lymphoma in Intensification Therapy and Transplantation (BENEFIT)	NCT02008006	Follicular Lymp...	BeEAM	18 Years - 65 Years	Centre Leon Berard
BENdamustine at Elevated Dose for Relapsed Follicular Lymphoma in Intensification Therapy and Transplantation (BENEFIT)	NCT02008006	Follicular Lymp...	BeEAM	18 Years - 65 Years	Centre Leon Berard

Spots Global Cancer Trial Database for chemosensitive relapse