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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


Phase 2/Phase 3
18 Years
60 Years
Not Enrolling
Both
Lymphoma, Large-Cell, Diffuse

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event free survival.

Principal Investigator

Pierre Morel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Schaffner, Lens FRANCE

Authority:

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

Study ID:

LNH98-B2

NCT ID:

NCT00169130

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • lymphoma
  • autologous stem cell transplant
  • chemotherapy
  • BCL2
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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