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

NCT ID: NCT02406092

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-13
• Study Completion Date: 2021-06-30

Brief 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

Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab SC 1400 mg

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered as per standard local practice.

Doxorubicin

Intervention Type: DRUG

Doxorubicin will be administered as per standard local practice.

Vincristine

Intervention Type: DRUG

Vincristine will be administered as per standard local practice.

Prednisone

Intervention Type: DRUG

Prednisone will be administered as per standard local practice.

Fludarabine

Intervention Type: DRUG

Fludarabine will be administered as per standard local practice.

Interventions

Rituximab

Rituximab SC 1400 mg

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide will be administered as per standard local practice.

Intervention Type: DRUG

Doxorubicin

Doxorubicin will be administered as per standard local practice.

Intervention Type: DRUG

Vincristine

Vincristine will be administered as per standard local practice.

Intervention Type: DRUG

Prednisone

Prednisone will be administered as per standard local practice.

Intervention Type: DRUG

Fludarabine

Fludarabine will be administered as per standard local practice.

Intervention Type: DRUG

Other Intervention Names

MabThera®; Endoxan

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed, cluster of differentiation (CD)20+ DLBCL or CD20+ follicular NHL grade 1 to 3a, according to the world health organization (WHO) classification system
• Currently being treated with rituximab IV in the Induction or Maintenance setting, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square meter (mg/m^2) administered without interruption or early discontinuation because of tolerability issues
• Expectation and current ability for the participants to receive at least four additional cycles of treatment during the Induction phase or six additional cycles of treatment during the Maintenance phase (participants with follicular NHL)

Exclusion Criteria

• Transformed lymphoma or FL IIIB
• History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (>/=) 5 years prior to dosing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hôpital Dorban CHU Annaba, Service d'Hématologie

Annaba, , Algeria

EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

Blida, , Algeria

EHU Oran, Service d'Hématologie et de Thérapie Cellulaire

Oran, , Algeria

Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

Tizi Ouzou, , Algeria

CHU 20 Aout Service D'Onco-Hematologie Pediatrique

Casablanca, , Morocco

Clinique AlMadina; Service hematologie

Casablanca, , Morocco

Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie

Marrakesh, , Morocco

Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique

Rabat, , Morocco

CHU Fattouma Bourguiba, Monastir; Service d'hématologie

Monastir, , Tunisia

CHU Hédi Chacker; Service d'hématologie

Sfax, , Tunisia

CHU Farhat Hached; Service d'hématologie

Sousse, , Tunisia

Aziza Othmana Hospital; Clinical Haematology

Tunis, , Tunisia

Hopital Militaire d'instruction de Tunis; Service d'hématologie

Tunis, , Tunisia

Countries

Algeria; Morocco; Tunisia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ML28964

Identifier Type: -

Identifier Source: org_study_id