Know Cancer

or
forgot password

Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).


Phase 3
18 Years
59 Years
Not Enrolling
Both
CD20-Positive Large B-Cell Lymphoma

Thank you

Trial Information

Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).


This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and
the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated
High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .

The duration of the treatment period is approximately 25 weeks and patients are followed
until Death.

From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE
and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who
received HDC, 269 were randomized (R2) after hematological recovery to receive either
rituximab (n=139) or nothing (n=130).

The final analysis was performed in June 2005.


Inclusion Criteria:



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

- Aged from 18 to 59 years, eligible for transplant.

- Patient not previously treated.

- Age adjusted International Prognostic Index equal to 2 or 3.

- Having previously signed a written informed consent.

- Women of childbearing potential currently practicing an adequate method of
contraception.

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.

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

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

- Any serious active disease (according to the investigator’s decision).

- HIV, HTLV1 or HBV related disease.

- Any organ transplantation before inclusion.

- Pregnant women.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT

Principal Investigator

Corinne Haioun

Investigator Role:

Study Chair

Investigator Affiliation:

Hôpital Henri Mondor, Créteil, France

Authority:

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

Study ID:

LNH-98.3

NCT ID:

NCT00169169

Start Date:

October 1999

Completion Date:

August 2005

Related Keywords:

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

Name

Location