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Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

Primary Purpose

Untreated CD20-positive Large B-cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Rituximab + ACVBP regimen plus Pegfilgrastim
Autologous stem cell transplant
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated CD20-positive Large B-cell Lymphoma focused on measuring Diffuse large B cell lymphoma, Pegfilgrastim, Autotransplant

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification). Age >18 and < 61 years, eligible for transplant. Patient not previously treated. With at least two prognostic factors of the Aa-IPI. With a minimum life expectancy of 3 months. Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma. Neutrophils > 1.5 G/l and platelets > 100 G/l, unless if patient has a bone marrow infiltration. 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. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. 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 and during the study. Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception. Adult patient under tutelage.

Sites / Locations

  • Hôpital Henri Mondor
  • Service d'Hématologie Clinique - CHU Le Bocage
  • Hôpital Saint Louis
  • Service d'Hématologie - Centre Hospitalier Lyon-Sud
  • Centre Henri Becquerel
  • CHRU de Nancy Brabois

Outcomes

Primary Outcome Measures

To evaluate the optimal combined dose intensity of the drug regimen

Secondary Outcome Measures

Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival

Full Information

First Posted
September 12, 2005
Last Updated
August 21, 2018
Sponsor
Lymphoma Study Association
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00169143
Brief Title
Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
Official Title
Study of R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma (Age-adjusted Ipi >or= 2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2004 (Actual)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lymphoma Study Association
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).
Detailed Description
This is a phase II, multicentric, open-label, non-randomized study, evaluating the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI), and eligible for transplant. It is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a group sequential manner one planned interim analysis. The duration of the treatment period is approximately 26 weeks and patients are followed until Death. The total Duration of the study is expected to be 2.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated CD20-positive Large B-cell Lymphoma
Keywords
Diffuse large B cell lymphoma, Pegfilgrastim, Autotransplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab + ACVBP regimen plus Pegfilgrastim
Intervention Type
Procedure
Intervention Name(s)
Autologous stem cell transplant
Primary Outcome Measure Information:
Title
To evaluate the optimal combined dose intensity of the drug regimen
Secondary Outcome Measure Information:
Title
Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification). Age >18 and < 61 years, eligible for transplant. Patient not previously treated. With at least two prognostic factors of the Aa-IPI. With a minimum life expectancy of 3 months. Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma. Neutrophils > 1.5 G/l and platelets > 100 G/l, unless if patient has a bone marrow infiltration. 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. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. 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 and during the study. Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception. Adult patient under tutelage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Haioun, MD
Organizational Affiliation
Hôpital Henri Mondor, Créteil, France
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
Service d'Hématologie Clinique - CHU Le Bocage
City
Dijon
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Service d'Hématologie - Centre Hospitalier Lyon-Sud
City
Pierre-Bénite cedex
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
CHRU de Nancy Brabois
City
Vandoeuvre-les-Nancy
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12488289
Citation
Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019.
Results Reference
background
PubMed Identifier
11821454
Citation
Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.
Results Reference
background
PubMed Identifier
12560443
Citation
Vose JM, Crump M, Lazarus H, Emmanouilides C, Schenkein D, Moore J, Frankel S, Flinn I, Lovelace W, Hackett J, Liang BC. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol. 2003 Feb 1;21(3):514-9. doi: 10.1200/JCO.2003.03.040.
Results Reference
background
PubMed Identifier
10944137
Citation
Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
Results Reference
background
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
Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)

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Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

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