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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00814164
First received: December 23, 2008
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Leukemia
 Drug: clofarabine
Drug: daunorubicin hydrochloride
Genetic: cytogenetic analysis
Genetic: protein expression analysis
Other: immunologic technique
Other: pharmacological study
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Complete remission (CR) or complete remission in the absence of total platelet recovery (CRp) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: December 2008
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814164

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Meir Wetzler, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00814164     History of Changes
Other Study ID Numbers: CDR0000630678, RPCI-I-132208
Study First Received: December 23, 2008
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Roswell Park Cancer Institute:
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
 adult acute myelomonocytic leukemia (M4)
untreated adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
 Clofarabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013