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Non-Hodgkin LymphomaPhase 3NCT02406092

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

A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Non-Hodgkin Lymphoma, run by Hoffmann-La Roche at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
Rituximab, Cyclophosphamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
13 sitesin 3 countries
Study dates
13 Oct 2015to 30 Jun 2021
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Tunisia5 sites

  • CHU Fattouma Bourguiba, Monastir; Service d'hématologie

    Monastir, 5000

  • CHU Hédi Chacker; Service d'hématologie

    Sfax, 3025

  • CHU Farhat Hached; Service d'hématologie

    Sousse, 4000

  • Aziza Othmana Hospital; Clinical Haematology

    Tunis, 1008

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

    Tunis, 1008

Other trials in Tunisia

Algeria4 sites

  • Hôpital Dorban CHU Annaba, Service d'Hématologie

    Annaba, 23000

  • EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

    Blida, 09000

  • EHU Oran, Service d'Hématologie et de Thérapie Cellulaire

    Oran, 31000

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

    Tizi Ouzou, 15000

Other trials in Algeria

Morocco4 sites

  • CHU 20 Aout Service D'Onco-Hematologie Pediatrique

    Casablanca, 20100

  • Clinique AlMadina; Service hematologie

    Casablanca, 20340

  • Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie

    Marrakesh, 40000

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

    Rabat, 10090

Other trials in Morocco

About this study

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

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).

Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called MabThera®

    Rituximab SC 1400 mg

  • CyclophosphamideDrug

    Also called Endoxan

    Cyclophosphamide will be administered as per standard local practice.

  • DoxorubicinDrug

    Doxorubicin will be administered as per standard local practice.

  • VincristineDrug

    Vincristine will be administered as per standard local practice.

  • PrednisoneDrug

    Prednisone will be administered as per standard local practice.

  • FludarabineDrug

    Fludarabine will be administered as per standard local practice.

Study groups in NCT02406092
Study groupRoleWhat they receive
RituximabExperimentalParticipants 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.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (7)

  1. Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria

    EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.

    Measured: From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])

  2. Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria

    PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.

    Measured: From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])

  3. Overall Survival (OS)

    OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.

    Measured: From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])

  4. Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria

    DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.

    Measured: 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 32.7 Months])

  5. Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria

    CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999).

    Measured: From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])

  6. Healthcare Professional Questionnaire Score

    Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report

    Measured: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)

  7. Patient-Reported Rituximab Administration Questionnaire (RASQ) Score

    The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.

    Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range.

    For each domain was scored using the following formula:

    Domain score = [(Sum of completed item (question) responses / Number of completed items) - 1] x 100 / (Maximum possible item response value - Minimum possible item response value)

    The final RASQ domains is calculated using the formula:

    RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants.

    Measured: Up to 53.8 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study start13 Oct 2015
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406092
Sponsor's protocol ID
ML28964
Status last verified
Nov 2024
First submitted
23 Mar 2015
Last updated
21 Nov 2024

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