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Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A

NCT02406092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2024-11-21

Study results available
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Summary

This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).

Conditions

Interventions

DRUG

Rituximab

Rituximab SC 1400 mg

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as per standard local practice.

DRUG

Doxorubicin

Doxorubicin will be administered as per standard local practice.

DRUG

Vincristine

Vincristine will be administered as per standard local practice.

DRUG

Prednisone

Prednisone will be administered as per standard local practice.

DRUG

Fludarabine

Fludarabine will be administered as per standard local practice.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Algeria
  • Morocco
  • Tunisia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02406092 on ClinicalTrials.gov