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

This study has been terminated.
(Sponsor withdrew support)
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00814164
First received: December 23, 2008
Last updated: August 13, 2013
Last verified: August 2013

December 23, 2008
August 13, 2013
December 2008
June 2013   (final data collection date for primary outcome measure)
Complete remission (CR) or complete remission in the absence of total platelet recovery (CRp) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete remission (CR) or complete remission in the absence of total platelet recovery (CRp) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00814164 on ClinicalTrials.gov Archive Site
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Differences in disease-free and overall survival between patients whose cells do or do not demonstrate apoptosis following clofarabine and daunorubicin hydrochloride therapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Difference in disease-free and overall survival according to p53R2 protein sizes [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Difference in disease-free and overall survival according to multi-drug resistance protein expression [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Difference in disease-free and overall survival based on clofarabine triphosphate levels [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • A preliminary relationship between treatment outcome and biologic parameters [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Differences in disease-free and overall survival between patients whose cells do or do not demonstrate apoptosis following clofarabine and daunorubicin hydrochloride therapy [ Designated as safety issue: No ]
  • Difference in disease-free and overall survival according to p53R2 protein sizes [ Designated as safety issue: No ]
  • Difference in disease-free and overall survival according to multi-drug resistance protein expression [ Designated as safety issue: No ]
  • Difference in disease-free and overall survival based on clofarabine triphosphate levels [ Designated as safety issue: No ]
  • A preliminary relationship between treatment outcome and biologic parameters [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Drug: clofarabine
    IV
  • Drug: daunorubicin hydrochloride
    IV
  • Genetic: cytogenetic analysis
    Correlative study
  • Genetic: protein expression analysis
    Correlative Study
  • Other: immunologic technique
    Correlative Study
  • Other: pharmacological study
    Correlative Study
Experimental: 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.
Interventions:
  • Drug: clofarabine
  • Drug: daunorubicin hydrochloride
  • Genetic: cytogenetic analysis
  • Genetic: protein expression analysis
  • Other: immunologic technique
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
August 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814164
CDR0000630678, RPCI-I-132208
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Genzyme, a Sanofi Company
Principal Investigator: Meir Wetzler, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP