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A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia


Phase 1/Phase 2
60 Years
N/A
Not Enrolling
Both
Leukemia, Acute Myeloid Leukemia

Thank you

Trial Information

A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia


Inclusion Criteria:



- Adult men and women of at least 60 years of age at the time of entry or
randomization;

- Histologically proven AML with at least 20% myeloblasts based on bone marrow
aspiration and biopsy performed within 5 days prior to entry or randomization;
History of prior MDS allowed provided the patient has received no prior cytotoxic
therapy for MDS;

- Candidates for aggressive induction chemotherapy in the judgment of the Investigator;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see
Appendix A) documented within 5 days prior to entry or randomization. For patients
who are admitted to the hospital for evaluation and treatment of AML, ECOG
performance status should be determined prior to admission. For patients who are
admitted to the hospital for other reasons (e.g., acute medical problems), ECOG
performance status should be determined prior to entry or randomization.

- Must be able to, in the opinion of the Investigator, safely stop taking
antihypertensive medication 24 hours prior to amifostine administration;

- Women must be >1 year post-menopausal at the time the informed consent is signed.
Men of reproductive potential must agree to practice an effective method of avoiding
impregnation (including condom, abstinence, or sterile sexual partner) starting at
the initiation of induction therapy (i.e., start of ara-C administration), and must
agree to continue using such precautions while receiving idarubicin (± amifostine)
and ara-C and for 30 days after the last dose of ara-C therapy;

- Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 2.5
times upper limit of normal (ULN) within 5 days prior to entry or randomization;

- Serum creatinine less than or equal to 2.0 mg/dL within 5 days prior to entry or
randomization;

- Left ventricular ejection fraction (LVEF) greater than or equal to 50% on
two-dimensional echocardiography (2-D ECHO) within 5 days prior to entry or
randomization;

- Written informed consent (all sites) and HIPAA authorization (USA sites only)
obtained from the patient prior to receipt of any study medication or beginning study
procedures.

Exclusion Criteria:

- Prior cytotoxic therapy for AML or MDS (hydroxyurea or similar low-dose therapy to
control the white count prior to initiation of induction therapy [i.e., start of
ara-C administration] is not an exclusion);

- Diagnosis of acute promyelocytic leukemia (FAB M3 AML);

- Prior diagnosis of AHD (Antecedent Hematologic Disorder, e.g. Polycythemia Vera);

- Known central nervous system (CNS) involvement;

- Life expectancy, in the opinion of the Investigator, of < 3 months due to co-morbid
conditions unrelated to AML;

- History of prior malignancies within the last six (6 mos.) that have required the
administration of systemic cytotoxic chemotherapy or other systemic bone marrow
cytotoxic agents or therapies,or radiation therapy of any kind to areas of the body
containing bone marrow;

- History of prior anthracycline use;

- Prior treatment with other investigational agents within 4 weeks prior to entry or
randomization;

- Current or planned participation (from the day of entry or randomization through 30
days after the last dose of ara-C therapy) in a research protocol in which an
investigational agent or therapy may be administered;

- Infection with human immunodeficiency virus (HIV) or active viral hepatic infections
based on patient's medical history elicited by the Investigator within 5 days prior
to entry or randomization;

- Any evidence of or history elicited by the Investigator of angina, acute or chronic
congestive heart failure, or pericardial effusion within 6 months prior to entry or
randomization;

- Any evidence of or history elicited by the Investigator of uncontrolled or refractory
hypertension despite medication within 6 months prior to entry or randomization;

- Any evidence of or history elicited by the Investigator of a myocardial infarction
within the last 6 months prior to randomization;

- Any evidence of cerebrovascular accident (CVA) with unstable neural deficits within 6
months prior to entry or randomization.

- Any evidence of transient ischemia attack (TIA) or symptomatic cerebrovascular
disease within 6 months prior to entry or randomization;

- Any evidence of clinically significant cardiac arrhythmia including prolongation of
QT interval that cannot be controlled with medication or is unstable or symptomatic
within 2 months prior to entry or randomization;

- A general medical or psychological condition or behavior, including substance
dependence or abuse that, in the opinion of the Investigator, might not permit the
patient to complete the study or sign the informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinically significant hematologic and non-hematologic toxicities associated with idarubicin administration

Outcome Time Frame:

30 days after last dose

Safety Issue:

Yes

Principal Investigator

Dirk J. Reitsma, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

MI-CP103

NCT ID:

NCT00086099

Start Date:

July 2004

Completion Date:

February 2006

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Medical College of WisconsinMilwaukee, Wisconsin  53226
Rush University Medical CenterChicago, Illinois  60612-3824
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Care CenterNew Albany, Indiana  47150
Scripps Cancer CenterLa Jolla, California  92037
Henry Ford Health SystemDetroit, Michigan  48202
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Spectrum Health Hospitals-Cook Research Dept. (No longer recruiting)Grand Rapids, Michigan  49503
Great Lakes Cancer Center Management SpecialtiesGrosse Point Woods, Michigan  48236
Cancer Management Specialists (No longer Recruiting)Grosse Pointe Woods, Michigan  48236
St. Barnabas Health Care CenterNewark, New Jersey  07112
Cleveland Clinic Foundation-Hemoatology/OncologyCleveland, Ohio  44195-001
Thomas Jefferson University Medical CollegePhiladelphia, Pennsylvania  19107
Baptist Clinical Research CenterMemphis, Tennessee  38120