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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)

Phase 2
18 Years
61 Years
Not Enrolling
Untreated CD20-Positive Large B-Cell Lymphoma

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Trial Information

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)

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.

Inclusion Criteria:

- Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the optimal combined dose intensity of the drug regimen

Principal Investigator

Corinne Haioun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hôpital Henri Mondor, Créteil, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

LNH 03-39B



Start Date:

May 2004

Completion Date:

January 2007

Related Keywords:

  • Untreated CD20-Positive Large B-Cell Lymphoma
  • Diffuse large B cell lymphoma
  • Pegfilgrastim
  • Autotransplant
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse