Overview

This trial is active, not recruiting.

Condition lymphoma, non hodgkin
Treatment rituximab [mabthera/rituxan]
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Start date November 2013
End date May 2017
Trial size 140 participants
Trial identifier NCT01987505, ML28943

Summary

This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of MabThera/Rituxan during first-line treatment for patients with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of MabThera/Rituxan IV. Patients with FL will be given 1400 mg MabThera/Rituxan SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of MabThera/Rituxan will be given to patients with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for patients with DLBCL and up to 32 months for patients with FL.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rituximab [mabthera/rituxan]
1400 mg injected subcutaneously (SC)

Primary Outcomes

Measure
Incidence of administration-associated reactions (AARs)
time frame: Up to 32 months

Secondary Outcomes

Measure
Grade >/= 3 Adverse events (AEs)
time frame: Up to 32 months
Serious AEs
time frame: Up to 32 months
Event-free survival, defined as the time from the first dose of MabThera/Rituxan IV until disease progression or relapse, initiation of new therapy or death.
time frame: Up to 32 months
Overall survival defined as the time from the first dose of MabThera/Rituxan until death
time frame: Up to 32 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Age >/= 18 and /= 6 months. - Eastern Cooperative Oncology Group (ECOG) performance status /= 1.5 cm as measured by computed tomography (CT) scan. FL treatment-related criteria - Currently being treated with MabThera/Rituxan IV during first-line therapy and has received at least one full dose of MabThera/Rituxan IV. Exclusion Criteria: - Transformed lymphoma. - Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma. - History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Patients with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study. - Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: patients receiving corticosteroid treatment with

Additional Information

Official title OPEN LABEL, SINGLE-ARM, PHASE IIIb CLINICAL TRIAL TO EVALUATE THE SAFETY OF SWITCHING FROM INTRAVENOUS RITUXIMAB TO SUBCUTANEOUS RITUXIMAB DURING FIRST LINE TREATMENT FOR CD20+ NON-HODGKIN'S FOLLICULAR LYMPHOMA AND DIFFUSE LARGE B-CELL LYMPHOMA.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.