Clinical trial NCT00169143: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Untreated CD20-positive Large B-cell Lymphoma
Keywords: Diffuse large B cell lymphoma
Pegfilgrastim
Autotransplant
Lead sponsor: Lymphoma Study Association
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate the optimal combined dose intensity of the drug regimen
Secondary outcomes:
measure: Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Service d'Hématologie Clinique - CHU Le Bocage
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre-Bénite cedex
country: France
facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU de Nancy Brabois
Study officials:
affiliation: Hôpital Henri Mondor, Créteil, France
name: Corinne Haioun, MD
role: STUDY_CHAIR
References:
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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.
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.
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.
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.