NCT00086099

Brief Summary

The primary objectives of this study are:

  1. 1.To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and
  2. 2.To estimate the complete remission rate of induction therapy with amifostine, idarubicin (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in this patient population.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_1 leukemia

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2004

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

1.4 years

First QC Date

June 23, 2004

Last Update Submit

January 28, 2009

Conditions

LeukemiaAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

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

    30 days after last dose

  • Incidence rate of amifostine-associated hypotension results in amifostine dose reduction, discontinuation of amifostine, or causes the development of serious cardiovascular or cerebrovascular events will be estimated

    30 days after last dose

Secondary Outcomes (2)

  • Duration of Complete Remission

    Estimated by analysis cohort using Kaplan-Mier Method

  • Overall Survival

    19 mos. after last patient entered or randomized (whichever was earlier).

Study Arms (2)

1

EXPERIMENTAL

Idarubicin plus amifostine

Drug: Idarubincin and Amufostine (Ethyol)

2

EXPERIMENTAL

Idarubincin

Drug: Idarubincin

Interventions

Idarubincin and Amufostine (Ethyol)DRUG

Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)

1
IdarubincinDRUG

Idarubincin (12mg/m2) and ara-C(N-18)

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Scripps Cancer Center

San Diego, California, 92121, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Spectrum Health Hospitals-Cook Research Dept. (No longer recruiting)

Grand Rapids, Michigan, 49503, United States

Location

Great Lakes Cancer Center Management Specialties

Grosse Point Woods, Michigan, 48236, United States

Location

Cancer Management Specialists (No longer Recruiting)

Grosse Pointe Woods, Michigan, 48236, United States

Location

St. Barnabas Health Care Center

Newark, New Jersey, 07112, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1082, United States

Location

Cleveland Clinic Foundation-Hemoatology/Oncology

Cleveland, Ohio, 44195-001, United States

Location

Thomas Jefferson University Medical College

Philadelphia, Pennsylvania, 19107, United States

Location

Baptist Clinical Research Center

Memphis, Tennessee, 38120, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan Med. Center

Rehovot, 76100, Israel

Location

Sheba Medical Center

Tel Hasomer, 52620, Israel

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur Compounds

Study Officials

  • Dirk J. Reitsma, M.D.

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2004

First Posted

June 25, 2004

Study Start

July 1, 2004

Primary Completion

December 1, 2005

Study Completion

February 1, 2006

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

US(15)IL(4)