Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation. - Manteau 2007 SJ LyMa (Young Subjects)
- Conditions
- Maintenance therapy in patients carriying a mantle cell lymphoma as response.MedDRA version: 14.1Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2007-004644-70-DE
- Lead Sponsor
- GOELAMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 299
•Confirmation of the diagnosis of mantle cell lymphoma according to the WHO classification, including all these variants: typical forms and blastoid variants.
•Initial minimal immunophenotyping is mandatory and will include CD20 and CD5.
•CD20+.
•With the presence of the t (11;14) demonstrated by karyotyping, FISH, molecular biology or immunohistochemistry (by detecting Bcl-1).
•Patient receiving first-line chemotherapy.
•With at least one tumor site accessible for assessment, not just bone marrow involvement. Patients with only blood and bone marrow and/or splenic involvement are excluded.
•Aged between 18 years and 65 years inclusive.
•ECOG 0-1 or 2.
•No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
•Patients who have signed an informed consent form.
•Ventricular ejection fraction >=50% measured using an ultrasound or radionuclide method.
•No contraindication to the use of the drugs contained in the regimen.
•With the following limits for laboratory values, unless the abnormal values are related to the lymphoma:
- Neutrophil count >=1 G/L
- Platelet count >= 50 G/L
- Transaminases (AST and ALT) <= 3 x normal (N)
- Bilirubin <= 2 x N
-Calculated creatinine clearance >= 50 mL/min
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Other types of lymphoma besides mantle cell lymphoma, according to the WHO classification.
•Patient in relapse, except relapse after localized disease only previously treated by locoregional irradiation or patient who has undergone splenectomy.
•Contraindication to one of the drugs used in the regimen.
•Uncontrolled diabetes.
•HIV + or active hepatitis C or B.
•Poor performance status: ECOG > 3 (see appendices).
•Patient is unable, for whatever reason, to undergo regular surveillance.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to demonstrate the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.;Secondary Objective: To evaluate the duration of progression-free survival of the entire group of patients.<br>To evaluate the duration of overall survival of the entire group of patients.<br>To evaluate the complete, partial and overall response rate after induction with R-DHAP and after ASCT.<br>;Primary end point(s): The primary endpoint is 4-year event-free survival (EFS) (determined using the Kaplan Meier method) of patients who underwent ASCT and were randomized to one of the two arms of the protocol.<br><br>
- Secondary Outcome Measures
Name Time Method