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

Inclusion Criteria

• •Histologically confirmed follicular lymphoma relapsed (WHO grade 1, 2, 3a)
• •Patients aged from 18 to 65 years
• •First or second chemosensitive relapses after salvage therapy (rituximab-chemotherapy) based on 2007 Cheson et al. international response criteria (CR and PR) before the decision of BeEAM (HDT) and ASCT (autologous stem cell transplantation) treatment
• •Eligible for ASCT
• •Autologous graft with a minimum of a number of cluster of differentiation 34 (CD34+) cells 3.0x106/kg.
• •Autologous transplantation will be performed in hematopoietic stem cell transplantation authorized centers.
• •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2
• •Minimum life expectancy of 3 months
• •Cardiovascular baseline corrected QT interval F ( QTcF) ≤ 450 msec (male) or 470 msec (female)
• •Medications that may cause corrected QT interval (QTc) interval prolongation should be avoided by patients entering on trial
• •Normal organ and marrow function as defined below:
• •* Absolute neutrophil count ≥ 1.5 G/l
• •* Platelet count ≥ 100 G/l or \> 75 G/l if the bone marrow is involved
• •* Creatine clearance ≥ 50 ml/min
• •* Serum Glutamate Oxaloacetate Transaminase (SGOT) and Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5 x ULN if liver metastasis
• •* Total bilirubin ≤ 1.5 x ULN
• •Cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan (MUGA scan)
• •Negative serum pregnancy test for women of childbearing potential\*
• •Pregnancy tests will include a negative serum pregnancy test (with a sensitivity of at least 25 mill-International Unit (mIU)/ml)
• •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
• •* Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
• •* ≥ 50 years old and naturally amenorrheic for ≥ 1 year
• •* Permanent premature ovarian failure confirmed by a specialist gynecologist
• •* Previous bilateral oophorectomy
• •* XY genotype, Turner's syndrome or uterine agenesis
• •* Female patients who do not meet at least of the above criteria are defined as women of childbearing potential
• •Ability to understand and willingness to sign a written informed consent document
• •Covered by a medical insurance
• •Signed informed consent