search
Back to results

A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma (LNH2007-3B)

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
R-CHOP14 induction regimen
R-ACVBP14 induction regimen
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Lymphoma, PET, Chemotherapy, Rituximab

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • René Olivier Casasnovas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

R-CHOP-14

R-ACVBP14

Arm Description

R-CHOP14 induction regimen

R-ACVBP14 induction regimen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2007
Last Updated
August 12, 2014
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT00498043
Brief Title
A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma
Acronym
LNH2007-3B
Official Title
Randomized Phase II Study of Two Associations of Rituximab and Chemotherapy, With a PET -Driven Strategy, in Patients From 18 to 59 With DLBCL CD20+ Lymphoma and 2 or 3 Adverse Prognostic Factors of the Age-adjusted IPI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
1) Induction Arm A: 4 cycles of R-ACVBP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF. The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4). Consolidation 1A (in case of PET 2- PET 4 -): High-dose Methotrexate with folinic acid rescue; 2 cycles spaced out 14 days. Rituximab-Ifosfamide-Etoposide : 4 cycles spaced out 14 days Cytarabine sub-cutaneous, during 4 days; 2 cycles spaced out 14 days. Consolidation 2 A (in case of PET 2+ PET4 -): 2 cycles high-dose Methotrexate with folinic acid rescue High dose with Z- BEAM conditioning regimen followed by autologous transplant. Salvage(in case of PET 4 +): The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible. 2) Induction arm B: 4 cycles of R-CHOP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF. The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4). Consolidation 1B(in case of PET 2- PET 4 -): 4 additional cycles of R-CHOP, 2-weeks interval Consolidation 2 B(in case of PET 2+ PET 4 -): 2 cycles high-dose Methotrexate with folinic acid rescue High dose with Z- BEAM conditioning regimen followed by autologous transplant Salvage(in case of PET 4 +): The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell, Lymphoma, Large-Cell, Diffuse
Keywords
Lymphoma, PET, Chemotherapy, Rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP-14
Arm Type
Experimental
Arm Description
R-CHOP14 induction regimen
Arm Title
R-ACVBP14
Arm Type
Experimental
Arm Description
R-ACVBP14 induction regimen
Intervention Type
Drug
Intervention Name(s)
R-CHOP14 induction regimen
Intervention Description
R-CHOP14 induction regimen
Intervention Type
Drug
Intervention Name(s)
R-ACVBP14 induction regimen
Intervention Description
R-ACVBP14 induction regimen
Primary Outcome Measure Information:
Title
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
Time Frame
4 inductive cycles with R-ACVBP14 or R-CHOP14
Secondary Outcome Measure Information:
Title
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
Time Frame
2 cycles and 4 cycles Induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Coiffier, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
René Olivier Casasnovas
City
Dijon
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33097974
Citation
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.
Results Reference
derived
PubMed Identifier
28251914
Citation
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.
Results Reference
derived
PubMed Identifier
21518924
Citation
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.
Results Reference
derived
Links:
URL
http://www.gela.org
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs