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

7 juli 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

21

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • Buffalo, New York, Verenigde Staten, 14263-0001
        • Roswell Park Cancer Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar tot 120 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Genetisch: analyse van eiwitexpressie
Correlatieve studie
Ander: farmacologische studie
Correlatieve studie
Geneesmiddel: clofarabine
IV
Geneesmiddel: daunorubicin hydrochloride
IV
Genetisch: cytogenetic analysis
Correlative study
Ander: immunologic technique
Correlative Study

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Complete Remission (CR)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Disease-free Survival
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 4 years
4 years
Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes
Tijdsspanne: 4 years
4 years
Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression
Tijdsspanne: 4 years
4 years
Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels
Tijdsspanne: 4 years
4 years
A Preliminary Relationship Between Treatment Outcome and Biologic Parameters
Tijdsspanne: 4 years
4 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Roswell Park Cancer Institute

Medewerkers

Genzyme, a Sanofi Company

Onderzoekers

  • Hoofdonderzoeker: Meir Wetzler, MD, Roswell Park Cancer Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2008

Primaire voltooiing (Werkelijk)

1 juni 2013

Studie voltooiing (Werkelijk)

1 augustus 2013

Studieregistratiedata

Eerst ingediend

23 december 2008

Eerst ingediend dat voldeed aan de QC-criteria

23 december 2008

Eerst geplaatst (Schatting)

24 december 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

17 augustus 2016

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000630678
  • RPCI-I-132208 (Andere identificatie: Roswell Park Cancer Institute)

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