EUCTR2007-004644-70-DE
Active, not recruiting
Not Applicable
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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maintenance therapy in patients carriying a mantle cell lymphoma as response.
- Sponsor
- GOELAMS
- Enrollment
- 299
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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