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

5 novembre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

420

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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®)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Droga: citarabina
Dato IV
Droga: laromustine
Given IV
Comparatore attivo: 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).
Droga: citarabina
Dato IV
Altro: placebo
Dato IV

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Tasso di risposta complessivo

Misure di risultato secondarie

Misura del risultato
Tossicità
Durata della risposta
Risposta complessiva
Tempo di progressione del tumore

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vion Pharmaceuticals

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2005

Completamento primario (Effettivo)

1 marzo 2008

Completamento dello studio (Effettivo)

1 marzo 2008

Date di iscrizione allo studio

Primo inviato

2 giugno 2005

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2005

Primo Inserito (Stima)

3 giugno 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 novembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2013

Ultimo verificato

1 febbraio 2009

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDR0000430677
  • VION-CLI-037

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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