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Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

R mini CHOP

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R mini CHOP

Arm Description

Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks

Outcomes

Primary Outcome Measures

Evaluating efficacy of R-miniCHOP by overall survival

Secondary Outcome Measures

Evaluating R-miniCHOP efficacy by Event free survival

Full Information

NCT ID

NCT01087424

First Posted

August 26, 2009

Last Updated

August 22, 2019

Sponsor

Lymphoma Study Association

1. Study Identification

Unique Protocol Identification Number

NCT01087424

Brief Title

Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Official Title

Phase II Study of Mini-CHOP Plus Rituximab in Non Previously Treated Patients Aged Over 80 Years With CD 20+ Diffuse Large B-Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lymphoma Study Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-Cell Lymphoma

Keywords

Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

R mini CHOP

Arm Type

Experimental

Arm Description

Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks

Intervention Type

Drug

Intervention Name(s)

R mini CHOP

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluating efficacy of R-miniCHOP by overall survival

Time Frame

2 years overall survival

Secondary Outcome Measure Information:

Title

Evaluating R-miniCHOP efficacy by Event free survival

Time Frame

2 years event free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

27282998

Citation

Ghesquieres 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. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

Results Reference

derived

PubMed Identifier

26373676

Citation

Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

Results Reference

derived

PubMed Identifier

21482186

Citation

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, Andre M, Fournier M, Gaulard P, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA) investigators. 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. Lancet Oncol. 2011 May;12(5):460-8. doi: 10.1016/S1470-2045(11)70069-9. Epub 2011 Apr 7.

Results Reference

derived

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Mini-CHOP and Rituximab in Patients Aged Over 80 Years

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