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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Fludarabine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Dorban CHU Annaba, Service d'Hématologie
  • EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
  • EHU Oran, Service d'Hématologie et de Thérapie Cellulaire
  • Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie
  • CHU 20 Aout Service D'Onco-Hematologie Pediatrique
  • Clinique AlMadina; Service hematologie
  • Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie
  • CHU Ibn Sina Rabat Service de medecine interne
  • CHU Fattouma Bourguiba, Monastir; Service d'hématologie
  • CHU Hédi Chacker; Service d'hématologie
  • CHU Farhat Hached; Service d'hématologie
  • Aziza Othmana Hospital; Clinical Haematology
  • Hopital Militaire d'instruction de Tunis; Service d'hématologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Administration-Associated Reactions (AARs)
AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.

Secondary Outcome Measures

Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria
Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria
Overall Survival (OS)
Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria
Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria
Healthcare Professional Questionnaire Score
Patient-Reported Rituximab Administration Questionnaire (RASQ) Score

Full Information

First Posted
March 23, 2015
Last Updated
September 29, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02406092
Brief Title
Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
Official Title
An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera®
Intervention Description
Rituximab SC 1400 mg
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan
Intervention Description
Cyclophosphamide will be administered as per standard local practice.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin will be administered as per standard local practice.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine will be administered as per standard local practice.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone will be administered as per standard local practice.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine will be administered as per standard local practice.
Primary Outcome Measure Information:
Title
Percentage of Participants With Administration-Associated Reactions (AARs)
Description
AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.
Time Frame
Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)
Secondary Outcome Measure Information:
Title
Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria
Time Frame
From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [up to 8 months])
Title
Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria
Time Frame
From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [up to 8 months])
Title
Overall Survival (OS)
Time Frame
From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 8 months])
Title
Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria
Time Frame
From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [up to 8 months])
Title
Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria
Time Frame
From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [up to 8 months])
Title
Healthcare Professional Questionnaire Score
Time Frame
End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)
Title
Patient-Reported Rituximab Administration Questionnaire (RASQ) Score
Time Frame
FL participants: Baseline, end of induction treatment/early termination (ET) (up to 8 months), end of maintenance treatment/ET (up to 24 months); DLBCL participants: Baseline, end of treatment/ET (up to 8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Dorban CHU Annaba, Service d'Hématologie
City
Annaba
ZIP/Postal Code
23000
Country
Algeria
Facility Name
EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
City
Blida
ZIP/Postal Code
09000
Country
Algeria
Facility Name
EHU Oran, Service d'Hématologie et de Thérapie Cellulaire
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Facility Name
Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie
City
Tizi Ouzou
ZIP/Postal Code
15000
Country
Algeria
Facility Name
CHU 20 Aout Service D'Onco-Hematologie Pediatrique
City
Casablanca
ZIP/Postal Code
20100
Country
Morocco
Facility Name
Clinique AlMadina; Service hematologie
City
Casablanca
ZIP/Postal Code
20340
Country
Morocco
Facility Name
Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
CHU Ibn Sina Rabat Service de medecine interne
City
Rabat
ZIP/Postal Code
10090
Country
Morocco
Facility Name
CHU Fattouma Bourguiba, Monastir; Service d'hématologie
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
CHU Hédi Chacker; Service d'hématologie
City
Sfax
ZIP/Postal Code
3025
Country
Tunisia
Facility Name
CHU Farhat Hached; Service d'hématologie
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Aziza Othmana Hospital; Clinical Haematology
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Facility Name
Hopital Militaire d'instruction de Tunis; Service d'hématologie
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia

12. IPD Sharing Statement

Learn more about this trial

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

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