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Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00227695
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE June 8, 2004
Actual Primary Completion Date May 3, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
Event-free survival [ Time Frame: at 10 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
  • Progression-free survival [ Time Frame: at 10 years ]
  • Overall survival [ Time Frame: at 10 years ]
  • Adverse reactions during and after maintenance treatment [ Time Frame: 10 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
Official Title  ICMJE Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial
Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

  • Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab, in terms of event-free survival, in patients with follicular non-Hodgkin's lymphoma.

Secondary

  • Compare the safety of these regimens in these patients.
  • Compare the pharmaeconomical aspects of these regimens in these patients.
  • Compare the evolution of immunologic competence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

  • Induction therapy: Patients receive rituximab IV weekly in weeks 1-4 and undergo restaging between weeks 11-13. Patients with stable disease or progressive disease are taken off study. Patients achieving partial or complete response are stratified according to prior treatment status (untreated* vs treated with or without anti-CD20 therapy), presence of bulky disease** at study entry (yes vs no), and participating center. Patients are then randomized to 1 of 2 maintenance treatment arms.

NOTE: *Patients treated with radiotherapy only are considered as therapy-naïve.

NOTE: **Defined as a mass or lymph node conglomerate ≥ 5 cm diameter.

  • Maintenance therapy: Patients start maintenance therapy within 7 days of randomization.

    • Arm I: Patients receive rituximab IV every 2 months for 4 treatments.
    • Arm II: Patients receive rituximab IV every 2 months for up to 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression or relapse and then annually for up to 10 years after randomization.

PROJECTED ACCRUAL: A total of 270 patients will be accrued for this study within 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Biological: rituximab
comparing two maintenance schedules of Rituximab
Other Name: MABTHERA
Study Arms  ICMJE
  • Active Comparator: Arm A: Rituximab every 2 months x4
    Rituximab 375 mg/m2 every 2 months x4
    Intervention: Biological: rituximab
  • Active Comparator: Arm B: Rituximab (5 years)
    Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
    Intervention: Biological: rituximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2006)
270
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 19, 2017
Actual Primary Completion Date May 3, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular lymphoma

    • Grade 1, 2, 3a, or 3b disease by WHO staging system
  • CD20-positive by immunohistochemistry
  • Previously untreated disease OR meets 1 of the following criteria for response to prior treatment:

    • Chemotherapy-resistant disease
    • Relapsed or progressive disease
    • Stable disease

      • At least 12 weeks since prior systemic treatment
  • At least 1 bidimensionally measurable lesion ≥ 11 mm by CT scan or MRI
  • No transformation to high-grade lymphoma secondary to low-grade follicular lymphoma
  • No prior or current CNS disease (i.e., CNS lymphoma or lymphomatous meningosis) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • Ejection fraction ≥ 50% by echocardiography or MUGA

Immunologic

  • No acute or ongoing infection
  • No HIV infection
  • No active autoimmune disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of the study treatment
  • No uncontrolled diabetes mellitus
  • No other medical condition that would preclude study participation
  • No other malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
  • No other condition (e.g., geographic proximity) that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Radiotherapy
  • Prior rituximab allowed

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • More than 4 weeks since prior regular administration of corticosteroids

    • Dose equivalent to ≤ 20 mg/day prednisone allowed for conditions other than lymphoma or lymphoma-related symptoms
  • No concurrent corticosteroids for prevention or treatment of side effects except acute life-threatening side effects

Radiotherapy

  • Prior radiolabeled anti-CD20 therapy (administered alone or in combination with cytostatic drugs) allowed provided patient has achieved partial or complete response after the therapy

    • At least 12 months since prior anti-CD20 therapy

Surgery

  • Not specified

Other

  • More than 30 days since prior systemic tumor therapy
  • More than 30 days since prior participation in another clinical trial
  • No other concurrent anticancer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Italy,   North Macedonia,   Serbia,   Slovakia,   South Africa,   Switzerland
Removed Location Countries Macedonia, The Former Yugoslav Republic of
 
Administrative Information
NCT Number  ICMJE NCT00227695
Other Study ID Numbers  ICMJE SAKK 35/03
SWS-SAKK-35/03
EU-20520
CDR0000443594
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor  ICMJE Swiss Group for Clinical Cancer Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christian Taverna, MD Kantonsspital Münsterlingen
Study Chair: Michele Ghielmini, Prof. IOSI - Ospedale San Giovanni, Bellinzona
PRS Account Swiss Group for Clinical Cancer Research
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP