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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


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR) or complete remission in the absence of total platelet recovery (CRp)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Meir Wetzler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000630678

NCT ID:

NCT00814164

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263