Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)
18 Years
75 Years
Both
Non-Hodgkin's Lymphoma
Trial Information
Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)
Inclusion Criteria:
- Adult patients, 18-75 years of age
- Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
- Previously treated with chemotherapy with autologous haemotopoietic stem cell
transplantation (bone marrow or peripheral blood cells)
Exclusion Criteria:
- Active viral hepatitis
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Patients not willing to sign informed consent form
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment response rate according to World Health Organization criteria (Group A)
Outcome Time Frame:
Day 50
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
M39012
NCT ID:
NCT01388959
Start Date:
November 1998
Completion Date:
April 2004
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
- Neoplasm, Residual
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