A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma

NCT00498043 | Completed Phase 2 DMC

• 1 other identifier: 2007.462
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.

Conditions

Lymphoma, B-Cell; Lymphoma, Large-Cell, Diffuse

Keywords

Lymphoma; PET; Chemotherapy; Rituximab

Outcome Measures

Primary Outcomes (1)

• Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles

  4 inductive cycles with R-ACVBP14 or R-CHOP14

Secondary Outcomes (1)

• Response according to PET after 2 cycles, 4 cycles Induction toxicities Response duration Disease-, progression-, event-free and overall survival after autologous transplant Biological factors for prognosis Pharmacokinetic of rituximab

  2 cycles and 4 cycles Induction

Study Arms (2)

R-CHOP-14

EXPERIMENTAL

R-CHOP14 induction regimen

Drug: R-CHOP14 induction regimen

R-ACVBP14

EXPERIMENTAL

R-ACVBP14 induction regimen

Drug: R-ACVBP14 induction regimen

Interventions

R-CHOP14 induction regimen DRUG

R-CHOP14 induction regimen

R-CHOP-14

R-ACVBP14 induction regimen DRUG

R-ACVBP14 induction regimen

R-ACVBP14

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
• Age from18 to 59 years, eligible for transplant.
• Patient not previously treated.
• Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.
• Index prognostic factors (IPI) 2 or 3.
• With a minimum life expectancy of 3 months.
• Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination).
• Having previously signed a written informed consent.

You may not qualify if:

• Any other histological type of lymphoma.
• Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
• Central nervous system or meningeal involvement by lymphoma.
• Contra-indication to any drug contained in the chemotherapy regimens.
• Poor renal function (creatinin level \>150 mmol/l), poor hepatic function (total bilirubin level \>30 mmol/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.
• Any serious active disease (according to the investigator's decision).
• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.
• Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
• Adult patient under tutelage.
• Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

René Olivier Casasnovas

Dijon, 21000, France

Location

Related Publications (4)

• Casasnovas RO, Meignan M, Berriolo-Riedinger A, Bardet S, Julian A, Thieblemont C, Vera P, Bologna S, Briere J, Jais JP, Haioun C, Coiffier B, Morschhauser F; Groupe d'etude des lymphomes de l'adulte (GELA). SUVmax reduction improves early prognosis value of interim positron emission tomography scans in diffuse large B-cell lymphoma. Blood. 2011 Jul 7;118(1):37-43. doi: 10.1182/blood-2010-12-327767. Epub 2011 Apr 25.

  PMID: 21518924 BACKGROUND

• Girum KB, Rebaud L, Cottereau AS, Meignan M, Clerc J, Vercellino L, Casasnovas O, Morschhauser F, Thieblemont C, Buvat I. 18F-FDG PET Maximum-Intensity Projections and Artificial Intelligence: A Win-Win Combination to Easily Measure Prognostic Biomarkers in DLBCL Patients. J Nucl Med. 2022 Dec;63(12):1925-1932. doi: 10.2967/jnumed.121.263501. Epub 2022 Jun 16.

  PMID: 35710733 DERIVED

• Blanc-Durand P, Jegou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodere F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.

  PMID: 33097974 DERIVED

• Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.

  PMID: 28251914 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bertrand Coiffier, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 9, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

FR (1)