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NCT01388959 Clinical Trial

A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01388959
Other study ID # M39012
Secondary ID
Status Completed
Phase Phase 2
First received July 5, 2011
Last updated November 1, 2016
Start date November 1998
Est. completion date April 2004

Study information
Verified date November 2016
Source Hoffmann-La Roche
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

This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rituximab [MabThera/Rituxan]
375 mg/m2 intravenously once a week for 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment response rate according to World Health Organization criteria (Group A) Day 50 No
Primary Normalization of B-cell lymphoma 2 levels Day 50 No
Secondary Safety: Incidence of adverse events 3 years No
Secondary Progression-free survival 3 years No
Secondary Duration of treatment response 3 years No
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