ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma

Lymphoma, Large-Cell, Diffuse Clinical Trial

Official title:

Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169130
• Other study ID #: LNH98-B2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: July 12, 2007
• Start date: October 1999

Study information

• Verified date: July 2007
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)

• Aged 18 to 60 years

• Non previously treated

• With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level

• Negative HIV, HBV and HCV serologies (except vaccination)

• With a minimum life expectancy of 3 months

• Having previously signed a written informed consent

Exclusion Criteria:

• Any history of treated or non-treated indolent lymphoma.

• T-cell lymphoma.

• Central nervous system or meningeal involvement by lymphoma.

• Any Contra-indication to any drug contained in the chemotherapy regimens.

• Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.

• Serious active disease (according to the investigator’s decision).

• Poor bone marrow reserve as defined by neutrophils <1.5G/l or platelets<100G/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.

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

• Childbearing woman.

• Patients previously treated with an organ transplantation.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• doxorubicin

• cyclophosphamide

Procedure:
• Autologous stem cell transplantation

Locations

Country	Name	City	State
Belgium	Service d'Hematologie	Mont-Godinne
France	Hôpital Henri Mondor	Creteil
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre Henri Becquerel	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Lymphoma Study Association	Fondation ARC

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival.
Secondary	Complete response rate at the end of treatment.
Secondary	Disease-free survival for complete responders.
Secondary	Overall survival.

External Links

•   Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French)