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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01388959

Enrollment

Registered

2011-07-07

Start date

1998-11-30

Completion date

2004-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Brief 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.

Interventions

DRUGrituximab [MabThera/Rituxan]

375 mg/m2 intravenously once a week for 4 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Treatment response rate according to World Health Organization criteria (Group A)	Day 50
Normalization of B-cell lymphoma 2 levels	Day 50

Secondary

Measure	Time frame
Safety: Incidence of adverse events	3 years
Progression-free survival	3 years
Duration of treatment response	3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026