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

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Roche

Status and phase

Completed
Phase 2

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: rituximab [MabThera/Rituxan]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01388959
M39012

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Single arm
Experimental group
Treatment:
Drug: rituximab [MabThera/Rituxan]

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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