Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

13. maj 2019 opdateret af: Swiss Group for Clinical Cancer Research

Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

270

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien
        • Clinical Center - Institute of Hematology
  • Italien
      • Milano, Italien, 20141
        • Istituto Europeo di Oncologia IEO
  • Nordmakedonien
      • Skopje, Nordmakedonien, 1000
        • Clinical Center Skopje
  • Schweiz
      • Aarau, Schweiz, CH-5001
        • Kantonspital Aarau
      • Baden, Schweiz, CH-5404
        • Kantonsspital Baden
      • Basel, Schweiz, CH-4016
        • St. Claraspital AG
      • Basel, Schweiz, CH-4031
        • Universitaetsspital Basel
      • Bellinzona, Schweiz, 6500
        • Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
      • Bern, Schweiz, 3010
        • Inselspital Bern
      • Breitenbach, Schweiz, 4226
        • Breitenbach Praxis Dr. Haberthür
      • Bruderholz, Schweiz, CH-4101
        • Kantonsspital Bruderholz
      • Chur, Schweiz, CH-7000
        • Kantonsspital Graubuenden
      • Geneva, Schweiz, CH-1211
        • Hôpital Cantonal Universitaire de Genève
      • Lausanne, Schweiz, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Liestal, Schweiz, CH-4410
        • Kantonsspital
      • Lugano, Schweiz, CH-6900
        • Istituto Oncologico della Svizzera Italiana
      • Neuchâtel, Schweiz, 2002
        • Hôpital Pourtalès
      • St. Gallen, Schweiz, CH-9007
        • Kantonsspital - St. Gallen
      • Thun, Schweiz, 3600
        • SpitalSTS AG Simmental-Thun-Saanenland
      • Zurich, Schweiz, CH-8091
        • Universitaetsspital Zuerich
      • Zurich, Schweiz, CH-8032
        • Klinik Hirslanden
      • Zurich, Schweiz, 8063
        • City Hospital Triemli
  • Serbien
      • Belgrade, Serbien, SCG-11000
        • Clinical Center of Serbia
  • Slovakiet
      • Bratislava, Slovakiet, 83310
        • NOU - National Institute for Oncology
  • Sydafrika
      • Cape Town, Sydafrika, 7500
        • Panorama Medical Centre
      • Johannesburg, Sydafrika, 2121
        • Sandton Oncology Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm A: Rituximab every 2 months x4
Rituximab 375 mg/m2 every 2 months x4
Biologisk: rituximab
comparing two maintenance schedules of Rituximab
Andre navne:
  • MABTHERA
Aktiv komparator: Arm B: Rituximab (5 years)
Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
Biologisk: rituximab
comparing two maintenance schedules of Rituximab
Andre navne:
  • MABTHERA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Event-free survival
Tidsramme: at 10 years
at 10 years

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: på 10 år
på 10 år
Progression-free survival
Tidsramme: at 10 years
at 10 years
Adverse reactions during and after maintenance treatment
Tidsramme: 10 years
10 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Swiss Group for Clinical Cancer Research

Efterforskere

  • Studiestol: Christian Taverna, MD, Kantonsspital Münsterlingen
  • Studiestol: Michele Ghielmini, Prof., IOSI - Ospedale San Giovanni, Bellinzona

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juni 2004

Primær færdiggørelse (Faktiske)

3. maj 2013

Studieafslutning (Faktiske)

19. december 2017

Datoer for studieregistrering

Først indsendt

26. september 2005

Først indsendt, der opfyldte QC-kriterier

26. september 2005

Først opslået (Skøn)

28. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SAKK 35/03
  • SWS-SAKK-35/03
  • EU-20520
  • CDR0000443594

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med rituximab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mozambique

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner