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Completed

NCT Number: NCT02406092

Safety Study of Rituximab (SC) Administered in Participants 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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Dorban CHU Annaba, Service d'Hématologie, Annaba, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

Rituximab SC 1400 mg

Other names: MabThera®

Cyclophosphamide

Drug

Cyclophosphamide will be administered as per standard local practice.

Other names: Endoxan

Doxorubicin

Drug

Doxorubicin will be administered as per standard local practice.

Vincristine

Drug

Vincristine will be administered as per standard local practice.

Prednisone

Drug

Prednisone will be administered as per standard local practice.

Fludarabine

Drug

Fludarabine will be administered as per standard local practice.

Primary outcomes

  1. Percentage of Participants With Administration-Associated Reactions (AARs)

    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)

    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 outcomes

  1. 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 53.8 Months])

    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.

  2. 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 53.8 Months])

    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.

  3. 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 51.1 Months])

    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.

  4. 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 32.7 Months])

    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.

  5. 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 32 Months])

    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).

  6. Healthcare Professional Questionnaire Score

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

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

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

    Time frame: Up to 53.8 Months

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2015
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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