Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma, R DHAP, ASCT, Rituximab Maintenance

Brief summary

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.

Detailed description

Demonstration of 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.

Yannick Le Bris, Barbara Burroni, Marguerite Fournier, Morgane Cheminant, Sara Ek et al. (15 authors)

Blood2024-11-05

10.1182/blood-2024-199152

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Mary Callanan, Caroline Milin, Marie‐Hélène Delfau‐Larue, Clément Bailly, Clémentine Sarkozy et al. (18 authors)

Blood2024-11-05

10.1182/blood-2024-208081

Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma

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Obinutuzumab Versus Rituximab in Transplant Eligible Untreated MCL Patients, a Matching Comparison between the Lyma and Lyma-101 Trials

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Sophie Kaltenbach, Yannick Le Bris, Bruno Tesson, Aurore Touzart, Guillaume Charbonnier et al. (21 authors)

Blood2023-11-02

10.1182/blood-2023-173815

Very long-term follow-up of rituximab maintenance in young patients with mantle cell lymphoma included in the LYMA trial, a LYSA study.

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Journal of Clinical Oncology2023-06-011 citations

10.1200/jco.2023.41.16_suppl.7508

Bendamustine-EAM versus R-BEAM after high-dose cytarabine-based induction in newly diagnosed patients with mantle cell lymphoma, a LYSA retrospective study.

Costes-Tertrais D, Hueso T, Gastinne T, Thieblemont C, Oberic L, Bouabdallah K, Garciaz S, Tchernonog E, Dartigeas C, Ribrag V, Fogarty P, Casasnovas RO, Houot R, Delette C, Malak S, Fornecker LM, Gressin R, Damaj G, Le Gouill S.

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Predictive Power of Early, Sequential MRD Monitoring in Peripheral Blood and Bone Marrow in Patients with Mantle Cell Lymphoma Following Autologous Stem Cell Transplantation with or without Rituximab Maintenance; Final Results from the LyMa-MRD Project, Conducted on Behalf of the Lysa Group

Mary Callanan, Elizabeth Macintyre, Marie‐Hélène Delfau‐Larue, Catherine Thiéblemont, Lucie Obéric et al. (18 authors)

Blood2020-11-049 citations

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Blood2020-11-04

10.1182/blood-2020-139990

Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma

Steven Le Gouill, Catherine Thiéblemont, Lucie Obéric, Philippe Moreau, Krimo Bouabdallah et al. (30 authors)

New England Journal of Medicine2017-09-27398 citations

10.1056/nejmoa1701769

Rituximab maintenance after autologous stem‐cell transplantation in patients with mantle cell lymphoma, final result of the <scp>LyMA</scp> trial conducted on behalf the <scp>LYSA</scp> group

Steven Le Gouill, Catherine Thiéblemont, Lucie Obéric, Anne‐Sophie Moreau, Krimo Bouabdallah et al. (25 authors)

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10.1002/hon.2438_74

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Blood2015-12-037 citations

10.1182/blood.v126.23.335.335

Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study

Steven Le Gouill, Catherine Thiéblemont, Lucie Obéric, Krimo Bouabdallah, Emmanuel Gyan et al. (20 authors)

Blood2014-12-0633 citations

10.1182/blood.v124.21.146.146

Interventions

OTHERWatch and wait

No treatment patient follow-up every 2 months during 3 years

DRUGRituximab

2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* mantle cell lymphoma * Initial immunophenotyping with CD20 and CD5. * CD20+. * t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1) * Patient no previous treated. * At least one tumor site accessible for assessment * Aged \> 18 years \< 65 * ECOG \< or = 2. * No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma. * signed informed consent * FEVG 50%

Exclusion criteria

* other type of lymphoma * ECOG \> or = 3 * relapse * serology VIH + Hepatite + * diabetis

Design outcomes

Primary

Measure	Time frame
event-free survival (EFS) post Rituximab maintenance therapy	EFS post 4 years after maintenance

Secondary

Measure	Time frame
duration of PFS of the entire group of patients.	Safety/efficacy of maintenance treatment
duration of OS of the entire group of patients	safety/efficacy of treatment
complete, partial and overall response rate after induction with R-DHAP and after ASCT.	safety/efficacy of all the treatment

Countries

France

Outcome results

None listed