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A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

NCT01461928

Description:

This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

A Study Comparing Maintenance Subcutaneous <span class="go-doc-concept go-doc-intervention">MabThera/Rituxan</span> (<span class="go-doc-concept go-doc-intervention">Rituximab</span>) With Observation Only in Patients With Relapsed or Refractory Indolent Non-Hodgkin's <span class="go-doc-concept go-doc-disease">Lymphoma</span> Who Had Responded to <span class="go-doc-concept go-doc-intervention">MabThera</span>-Based Immunochemotherapy Induction and Two Years of Maintenance With Subcutaneous <span class="go-doc-concept go-doc-intervention">MabThera</span>

Title

  • Brief Title: A Study Comparing Maintenance Subcutaneous MabThera/Rituxan (Rituximab) With Observation Only in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to MabThera-Based Immunochemotherapy Induction and Two Years of Maintenance With Subcutaneous MabThera
  • Official Title:
  • Clinical Trial IDs

    NCT ID: NCT01461928

    ORG ID: MO25455

    NCI ID: 2010-023407-95

    Trial Conditions

    Non-Hodgkin's Lymphoma

    Trial Interventions

    Drug Synonyms Arms
    chemotherapy A:Maintenance II period MabThera/Rituxan, B: Maintenance II period observation only
    rituximab [MabThera/Rituxan] A:Maintenance II period MabThera/Rituxan
    rituximab [MabThera/Rituxan] A:Maintenance II period MabThera/Rituxan, B: Maintenance II period observation only
    rituximab [MabThera/Rituxan] A:Maintenance II period MabThera/Rituxan, B: Maintenance II period observation only

    Trial Purpose

    This multicenter, randomized, parallel-group study will evaluate the efficacy and safety of
    subcutaneously (sc) administered MabThera/Rituxan (rituximab) in comparison with observation
    only as maintenance therapy in patients with relapsed or refractory indolent non-Hodgkin's
    lymphoma. All patients will receive 6-8 cycles of induction therapy with MabThera/Rituxan
    (375 mg/m2 iv in Cycle 1, then 1400 mg sc every 3-4 weeks) plus standard chemotherapy,
    followed by 24 months of maintenance therapy with MabThera/Rituxan (1400 mg sc every 8
    weeks). Patients completing therapy and showing partial or complete response will be
    randomized to receive either MabThera/Rituxan (1400 mg sc every 8 weeks) or observation with
    no treatment during maintenance phase II and will be followed for at least 15 months.
    Anticipated time on study treatment is until disease progression, unacceptable toxicity or
    end of study, whichever occurs first.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    A:Maintenance II period MabThera/Rituxan Experimental chemotherapy, rituximab [MabThera/Rituxan], rituximab [MabThera/Rituxan], rituximab [MabThera/Rituxan]
    B: Maintenance II period observation only Other chemotherapy, rituximab [MabThera/Rituxan], rituximab [MabThera/Rituxan]

    Eligibility Criteria

    Inclusion Criteria:

    - Adult patients, >/= 18 years of age

    - Histologically confirmed CD20+ indolent non-Hodgkin's lymphoma according to WHO
    classification system

    - Patients must have received and must have relapsed or been refractory to one or more
    lines of adequate therapy prior to enrolment, including at least one line consisting
    of immunotherapy and/or chemotherapy and/or radiotherapy

    - Eastern Cooperative Oncology Group (ECOG) performance status </= 2

    Additional criteria for prolonged maintenance (Maintenance II):

    - Completed MabThera/Rituxan-based Induction and initial 2-year maintenance
    (Maintenance I) therapy with sc MabThera/Rituxan

    - Partial response or complete response after Maintenance I

    Exclusion Criteria:

    - Transformation to high-grade lymphoma

    - Aggressive lymphoma (e.g. mantle cell lymphoma)

    - Presence or history of central nervous system (CNS) lymphomatous disease

    - Other malignancy within 5 years prior to enrolment, except for curatively treated
    carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell
    skin cancer, or cervical carcinoma stage 1B or less, breast cancer in situ or
    localized prostate cancer stage T1c if treated with curative intent and relapse- and
    metastasis-free for at least 2 years prior to enrolment

    - Inadequate hematological, hepatic or renal function

    - Positive for HIV infection

    - Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic
    infections, active hepatitis B or C)

    - Pregnant or breastfeeding women

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival (Maintenance II phase): from randomization to disease progression or death; tumour assessments according to the 1999 International Working Group response (Cheson) criteria for lymphoma

    Secondary Outcome Measures

    Safety: Incidence of adverse events

    Event-free survival (time to treatment failure): from day of first rituximab induction dose to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason

    Time to next lymphoma treatment: from day of first rituximab induction dose to any new lymphoma treatment

    Overall survival (from 1st induction dose/from time to randomization)

    Overall Response Rate

    Partial Response to Complete Response conversion rate (at end of Maintenance I phase)

    Progression-free survival: from day of first induction dose until disease progression or death by any cause

    Trial Keywords