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Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

7. juli 2016 opdateret af: Roswell Park Cancer Institute

A Phase II Study Evaluating Mechanisms of Resistance Following Treatment With Clofarabine and Daunorubicin in Newly Diagnosed Adult Acute Myeloid Leukemia Patients > or = to 60 Years Old

RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Study complete response (CR) and CR without platelet recovery (CRp) following treatment with clofarabine and daunorubicin hydrochloride in older patients with newly diagnosed acute myeloid leukemia.

Secondary

  • Study disease-free and overall survival of these patients following treatment with this regimen.
  • Compare disease-free and overall survival of patients whose cells do or do not demonstrate apoptosis following treatment with this regimen.

OUTLINE:

  • Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. Patients are assessed after induction course 1. Patients with ≥ 5% blasts in bone marrow may receive another course of induction therapy beginning between 28-84 days after initiation of course 1. Patients who achieve complete remission (CR) or CR without platelet recovery (CRp) (after 1 or 2 courses of induction therapy) proceed to consolidation therapy.
  • Consolidation therapy: Beginning between 28 -84 days after initiation of last course of induction therapy, patients receive clofarabine IV over 1 hour on days 1-3 and daunorubicin hydrochloride IV over 5 minutes on days 1 and 3. Patients may receive a second course of consolidation therapy beginning between 28-84 days of consolidation course 1.

Blood and bone marrow samples are collected periodically to assess response and for pharmacokinetic, cytogenetic, immunophenotyping, and molecular analyses.

After completion of study treatment, patients are followed for at least 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute

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

60 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute myeloid leukemia

    • At least 10% blasts in the peripheral blood
  • De novo or secondary disease
  • No acute promyelocytic leukemia with t[15;17] or any other variant
  • No clinical evidence of CNS disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • LVEF ≥ 45%
  • Estimated glomerular filtration rate ≥ 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment
  • No known HIV positivity
  • Able to comply with study procedures and follow-up examinations
  • No psychiatric disorders that would interfere with consent, study participation, or follow-up
  • No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)
  • No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents

  • No other malignancy, unless disease-free for at least 3 years following curative intent therapy

    • Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are allowed if definitive treatment for the condition has been completed
    • Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
  • No other severe concurrent disease

PRIOR CONCURRENT THERAPY:

  • No other concurrent systemic antileukemic therapy (standard or investigational)
  • No concurrent cytotoxic therapy or investigational therapy
  • No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)

  • No prior chemotherapy

    • Prior hydroxyurea allowed

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: Clorafarbine with daunorubicin
Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
Genetisk: proteinekspressionsanalyse
Korrelativ undersøgelse
Andet: farmakologisk undersøgelse
Korrelativ undersøgelse
Medicin: clofarabine
IV
Medicin: daunorubicin hydrochloride
IV
Genetisk: cytogenetic analysis
Correlative study
Andet: immunologic technique
Correlative Study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Remission (CR)
Tidsramme: 2 years
Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease-free Survival
Tidsramme: 5 years
Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.
5 years
Overall Survival
Tidsramme: 4 years
Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
4 years
Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy
Tidsramme: 4 years
4 years
Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes
Tidsramme: 4 years
4 years
Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression
Tidsramme: 4 years
4 years
Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels
Tidsramme: 4 years
4 years
A Preliminary Relationship Between Treatment Outcome and Biologic Parameters
Tidsramme: 4 years
4 years

Samarbejdspartnere og efterforskere

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

Sponsor

Roswell Park Cancer Institute

Samarbejdspartnere

Genzyme, a Sanofi Company

Efterforskere

  • Ledende efterforsker: Meir Wetzler, MD, Roswell Park Cancer Institute

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. december 2008

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

23. december 2008

Først indsendt, der opfyldte QC-kriterier

23. december 2008

Først opslået (Skøn)

24. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000630678
  • RPCI-I-132208 (Anden identifikator: Roswell Park Cancer Institute)

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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