BENEFIT : Bendamustine at Elevated dose for relapsed Follicular lymphoma in Intensification therapy and Transplantatio
- Conditions
- Follicular Lymphoma in 1st or 2nd relapseMedDRA version: 17.0 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000076-16-FR
- Lead Sponsor
- CENTRE LEON BERARD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
- Patient with histologically confirmed first or follicular lymphoma relapsed (WHO grade 1, 2, 3a)
- Aged from 18 to 65 years
- First or second chemosensitive relapses after salvage therapy (rituximab-chemotherapy) based on 2007 Cheson international response criteria (CR and PR) before the decision of BeEAM and ASCT (autologous stem cell transplantation) treatment
- Eligible for ASCT
- Autologous graft with a minimum of a number of CD34+ cells>= 3.0x106/kg.
- Autologous transplantation will be performed in hematopoietic stem cell transplantation authorized centers.
- ECOG Performance Status (PS) 0 to 2
- Minimum life expectancy of 3 months
- Cardiovascular baseline QTcF = 450 msec (male) or 470 msec (female)
- Normal organ and marrow function as defined below:
Absolute neutrophil count (ANC) = 1.5 109/l
Platelet count = 100x109/l or > 75x109/L if the bone marrow is involved
Creatine clearance = 50 mL/min (calculated by Cockcroft-Gault formula)
ALT and AST = 2.5xULN or = 5.0xULN if liver metastasis
Total bilirubin = 1.5xULN
- Cardiac ejection fraction greater than 50% by echocardiogram or MUGA scan
- Negative serum pregnancy test for women of childbearing potential
- 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
- Ability to understand and willingness to sign a written informed consent document
- Covered by a medical insurance
- Signed informed consent
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Transformed follicular lymphoma
- Tumor tissue sample not available for pathological review
- Prior autologous or allogeneic transplantation
- Presence of a none chemosensitive disease before HDT according to 2007 Cheson international response criteria (stable or progressive disease)
- Contraindication to any drug contained in the chemotherapy regimens
- Bone marrow infiltration > 25% before HDT+ASCT
- Positive HIV, HCV and HBs Ag serologies
- Current bacterial, viral or fungal infection
- Treatment with any investigational drug within 30 days before enrolment
- Major surgery within 30 days before enrolment
- Participation in another clinical trial within 30 days prior to enrolment in the study and during study
- Any serious active disease or co-morbid medical conditions that would interfere with therapy
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for = 5 years
- Known or suspected hypersensitivity to any of the agents or excipients of the regime under evaluation
- Concomitant treatment with chemotherapy or immunotherapy or radiotherapy
- Yellow fever vaccination (attenuated virus vaccine )
- Pregnant or lactating female
- Abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or a history of antihypertensive treatment poor compliance, uncontrolled arrhythmias with treatment, except extrasystoles or minor conduction disorders
- Known involvement of the central nervous system by lymphoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method