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SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

8. maj 2014 opdateret af: Cephalon

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

SUMMARY:

This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression.

RATIONALE:

Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients.

PURPOSE:

This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

66

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Darlinghurst, Australien, NSW 2010
        • St. Vincent's Hospital
      • Westmead, Australien, NSW 2145
        • Westmead Hospital
    • Victoria
      • East Melbourne, Victoria, Australien, 8006
        • Peter Maccallum Cancer Institute
      • Parkville, Victoria, Australien, 3050
        • Royal Melbourne Hospital
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre-Victoria General Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • The Royal Victoria Hospital Cancer Care Program Clinical Trials
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute
      • Sudbury, ,, Ontario, Canada, P3E 5J1
        • North Eastern Ontario Regional Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H2L 4MI
        • Hopital Notre-Dame du CHUM
  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Cancer Research and Education Center
    • California
      • Concord, California, Forenede Stater, 94520
        • Bay Area Cancer Research Group
      • La Verne, California, Forenede Stater, 91750
        • Wilshire Oncology Medical Group
      • Los Angeles, California, Forenede Stater, 90033
        • USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
      • Vista, California, Forenede Stater, 92081
        • San Diego Cancer Center
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06902-3628
        • Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown University Medical Center - Lombardi Cancer Center
    • Florida
      • New Port Richey, Florida, Forenede Stater, 34652
        • Pasco Hernando Oncology
    • Georgia
      • Columbus, Georgia, Forenede Stater, 31902
        • John B. Amos Cancer Center
      • Lawrenceville, Georgia, Forenede Stater, 30045
        • Suburban Hematology & Oncology Associates
      • Macon, Georgia, Forenede Stater, 31201
        • Georgia Oncology Partners Research and Education Foundation
    • Indiana
      • South Bend, Indiana, Forenede Stater, 46601
        • Northern Indiana Cancer Research Consortium
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006-2921
        • Oncology and Hematology
      • Shreveport, Louisiana, Forenede Stater, 71103
        • LSU Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel/Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University Of Michigan Comprehensive Cancer Center
    • Minnesota
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • Hubert H. Humphrey Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • The Cancer Institute of New Jersey
    • New York
      • Great Neck, New York, Forenede Stater, 11021
        • Arena Oncology Associates
      • New Hyde Park, New York, Forenede Stater, 11040
        • Long Island Jewish Medical Center
      • Rochester, New York, Forenede Stater, 14623
        • Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • ACORN - West Cancer Center
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor University Medical Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Univ. of Virginia Health System-Cancer Center Clinical Trials Office

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

INCLUSION CRITERIA:

Documented B-Cell NHL or mantle cell lymphoma

  • CD-20+ tumor
  • Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
  • Maximum of three prior chemotherapy regimens
  • Age of at least 18 years at Screening Visit (Site specific requirement may differ)

EXCLUSION CRITERIA:

  • Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
  • Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
  • Use of investigational agents within 28 days of study
  • History of prior high dose chemotherapy with allogeneic stem cell support
  • History of prior radioimmunotherapy

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
Medicin: bendamustine and rituximab
Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma
Tidsramme: 4-6 months
4-6 months

Sekundære resultatmål

Resultatmål
Tidsramme
• To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR)
Tidsramme: 4-6 months
4-6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Cephalon

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

1. april 2004

Primær færdiggørelse (Faktiske)

1. december 2005

Studieafslutning (Faktiske)

1. marts 2008

Datoer for studieregistrering

Først indsendt

20. januar 2004

Først indsendt, der opfyldte QC-kriterier

21. januar 2004

Først opslået (Skøn)

22. januar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SDX-105-02

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 .

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