Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Diffuse Large B-Cell Lymphoma

Brief summary

The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.

Jean‐Marie Michot, Cédric Portugues, Lucie Obéric, Fabrice Jardin, Vincent Delwail et al. (11 authors)

Blood2024-11-051 citations

10.1182/blood-2024-202588

Incidence and Risk Factors for Central Nervous System Relapse in Very Elderly Patients over 80 with Diffuse Large B-Cell Lymphoma: A Retrospective Analysis of Two Lysa Studies

Aurélie Cabannes‐Hamy, Frédéric Peyrade, Fabrice Jardin, Jean‐François Emile, Sylvie Castaigné et al. (18 authors)

Blood2016-12-02

10.1182/blood.v128.22.927.927

FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts.

Ghesquières H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G.

2016-06-1015 citations

10.1002/hon.2305

MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study

Christiane Copie‐Bergman, Peggy Cuillière-Dartigues, Maryse Baia, Josette Brière, Richard Delarue et al. (23 authors)

Blood2015-09-16250 citations

10.1182/blood-2015-05-647602

Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: a multicentre, single-arm, phase 2 trial.

Peyrade F, Jardin F, Thieblemont C, Thyss A, Emile JF, Castaigne S, Coiffier B, Haioun C, Bologna S, Fitoussi O, Lepeu G, Fruchart C, Bordessoule D, Blanc M, Delarue R, Janvier M, Salles B, André M, Fournier M, Gaulard P, Tilly H, Groupe d'Etude des Lymphomes de l'Adulte (GELA) investigators.

2011-04-07389 citations

10.1016/s1470-2045(11)70069-9

Interventions

DRUGR mini CHOP

Prednisone 40 mg/m2 D1 D2 D3 D4 D5 Rituximab 375 mg/m2 D1 Doxorubicine 25 mg/m2 D1 Cyclophosphamide 400 mg/m2 D1 Vincristine 1 mg/m2 D1

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

80 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included. * Aged over 80 years. * Ann Arbor stage I bulky, II, III or IV * Age-adjusted International Prognostic Index equal to 0, 1, 2 and 3. * Patient non previously treated. * ECOG performance status ≤ 2. * With a minimum life expectancy of 3 months. * Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination). * Having previously signed a written informed consent

Exclusion criteria

* Any other histological type of lymphoma. * Any history of treated or non-treated indolent lymphoma. * Central nervous system or meningeal involvement by lymphoma. * Contra-indication to any drug contained in the chemotherapy regimens. * Any serious active disease (according to the investigator's decision). * Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Poor bone marrow reserve as defined by neutrophils \<1.5 G/l or platelets \<100 G/l, unless related to bone marrow infiltration. * Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * Adult patient under tutelage.

Design outcomes

Primary

Measure	Time frame
Evaluating efficacy of R-miniCHOP by overall survival	2 years overall survival

Secondary

Measure	Time frame
Evaluating R-miniCHOP efficacy by Event free survival	2 years event free survival

Outcome results

None listed