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Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.


N/A
18 Years
60 Years
Not Enrolling
Both
Lymphoma, Large-Cell, Diffuse

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Trial Information

Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.


Diffuse Large B Cell Lymphoma not previously treated


Inclusion Criteria:



- Age ≥ 18 et ≤ 60 and male and female

- Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +

- Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor.

- Non previously treated

- HIV négative

- Signed informed consent

Exclusion Criteria:

- Age < 18 and/or > 60 ans

- NHL not DLBCL

- Lymphoblastic Lymphoma

- Burkitt's Lymphoma

- Low grade Lymphoma transformed

- Primary CNS Lymphomal

- Post- transplantation Lymphoma

- CD20 negative

- Ann Arbor stage I or II without tumor bulk > 7 cm

- Previous treatment

- HIV positive

- Contre-indication to Rituximab use according to SmPC

- Contre-indication to high dose chemotherapy due to organ failure not related to the
lymphoma

- Cancer or history of cancer with the exception of in situ cancer of the cervix or
non-invasive skin epithelioma

- Patient not able to understand the proposed treatments

- Refusal to sign the informed consent

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:

3 years Event-free survival ( Kaplan Meier method)

Principal Investigator

Noel Milpied, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Bordeaux

Authority:

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

Study ID:

BRD 04/4-O

NCT ID:

NCT00561379

Start Date:

April 2005

Completion Date:

May 2013

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • Diffuse Large B Cell Lymphoma
  • not previously treated
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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