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Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia

5. november 2013 opdateret af: Vion Pharmaceuticals

A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse

RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Compare the complete response (CR) and CR (with platelet count < 100,000/mm^3 but ≥ 20,000/mm^3 [transfusion independent for ≥ 7 consecutive days]) (CRp) rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M.

Secondary

  • Compare time to progression in patients treated with these regimens.
  • Compare duration of response in patients treated with these regimens.
  • Compare the survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. Patients are stratified according to age (< 60 years vs ≥ 60 years) and duration of first complete response (CR) or CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) (< 12 months vs ≥ 12 months).

  • Induction therapy: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
    • Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).

In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based on total cellularity and percent blasts) after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy.

  • Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp, patients receive 1 course of consolidation therapy, as per induction therapy, according to their randomized treatment arm. These patients may then proceed to other consolidation, maintenance, and/or intensification therapy (including stem cell transplantation) off study at the discretion of the physician.

After completion of study treatment, patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued for this study within 24-30 months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

420

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgien, B-3000
        • U.Z. Gasthuisberg
      • Montigny-le-Tilleul, Belgien, 6110
        • CHU Charleroi - Site Vesale
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E3
        • Vancouver Hospital and Health Science Center
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Memorial University of Newfoundland
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Capital District Health Authority Center for Clinical Research
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Regional Cancer Centre - General Campus
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Det Forenede Kongerige
    • England
      • Birmingham, England, Det Forenede Kongerige, B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge, England, Det Forenede Kongerige, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • Leicester Royal Infirmary
      • London, England, Det Forenede Kongerige, SE5 9RS
        • King's College Hospital
      • Manchester, England, Det Forenede Kongerige, M13 9WL
        • Manchester Royal Infirmary
    • Wales
      • Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
        • University Hospital of Wales
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, Forenede Stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Comprehensive Cancer Center
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Tampa, Florida, Forenede Stater, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • American Health Network - North Meridian
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Nevada Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • New Mexico Cancer Care Alliance
    • New York
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, Forenede Stater, 27858
        • Brody school of Medicine at East Carolina University
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43214-3998
        • Riverside Methodist Hospital Cancer Care
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
  • Frankrig
      • Besancon, Frankrig, 25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Lyon, Frankrig, 69437
        • Hôpital Edouard Herriot
      • Marseille, Frankrig, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Nantes, Frankrig, 44093
        • CHR Hotel Dieu
      • Pessac, Frankrig, 33604
        • Hôpital Haut Levêque
  • Grækenland
      • Athens, Grækenland, 10676
        • Evaggelismos Hospital
      • Rio Patras, Grækenland, GR-26500
        • University of Patras Medical School
  • Holland
      • Groningen, Holland, 9713 GZ
        • University Medical Center Groningen
  • Polen
      • Gdansk, Polen, 80-211
        • Medical University of Gdansk
      • Lodz, Polen, 90-419
        • Medical University of Lodz
      • Lublin, Polen, 20-954
        • Centrum Onkologii Ziemi Lubelskiez
      • Warsaw, Polen, 00-957
        • Institute of Haematology and Blood Transfusion
      • Warsaw, Polen, 00-909
        • Wojskowy Instytut Medyczny
  • Serbien
      • Belgrade, Serbien, 11000
        • Clinical Centre of Serbia
      • Nis, Serbien, 18000
        • Clinical Centre Nis
      • Novi Sad, Serbien, 21000
        • Clinic Centre Novi Sad
  • Tyskland
      • Berlin, Tyskland, D-12200
        • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Cologne, Tyskland, D-50924
        • Medizinische Universitaetsklinik I at the University of Cologne
      • Frankfurt, Tyskland, D-60596
        • Universitaetsfrauenklinik Frankfurt
      • Heidelberg, Tyskland, D-69115
        • Universitätsklinikum Heidelberg
      • Muenster, Tyskland, D-48149
        • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
      • Munich, Tyskland, D-81377
        • Klinikum der Universitaet Muenchen - Grosshadern Campus
      • Wurzburg, Tyskland, D-97070
        • University Würzburg

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 acute myeloid leukemia (AML)

    • Any WHO classification, excluding acute promyelocytic leukemia
    • At least 10% blasts by bone marrow aspirate and/or biopsy

  • In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen

    • Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Chronic hepatitis allowed

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No uncontrolled arrhythmias
  • No uncontrolled congestive heart failure

Pulmonary

  • No severe chronic obstructive pulmonary disease
  • No requirement for supplemental oxygen at rest

Immunologic

  • No uncontrolled active infection

    • Infections that are controlled and under active treatment with antibiotics allowed
  • No evidence of invasive fungal infection by blood or tissue cultures

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies
  • No other severe medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 12 hours since prior hydroxyurea

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior treatment while in first relapse except hydroxyurea
  • No other concurrent standard or investigational treatment for AML
  • No concurrent disulfiram (Antabuse®)

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
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Induction therapy arm I
Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
Medicin: cytarabin
Givet IV
Medicin: laromustine
Given IV
Aktiv komparator: Induction therapy arm II
Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
Medicin: cytarabin
Givet IV
Andet: placebo
Givet IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Samlet svarprocent

Sekundære resultatmål

Resultatmål
Toksicitet
Varighed af svar
Samlet respons
Tid til tumorprogression

Samarbejdspartnere og efterforskere

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

Sponsor

Vion Pharmaceuticals

Efterforskere

  • Bonny L. Johnson, RN, MSN, Vion Pharmaceuticals

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

1. marts 2005

Primær færdiggørelse (Faktiske)

1. marts 2008

Studieafslutning (Faktiske)

1. marts 2008

Datoer for studieregistrering

Først indsendt

2. juni 2005

Først indsendt, der opfyldte QC-kriterier

2. juni 2005

Først opslået (Skøn)

3. juni 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2013

Sidst verificeret

1. februar 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000430677
  • VION-CLI-037

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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