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Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia

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

NCT00086099•MedImmune LLC

View on ClinicalTrials.gov

Summary

The primary objectives of this study are: 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. 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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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;
+7 more criteria

Locations (19)

Scripps Cancer Center

San Diego, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Cancer Care Center

New Albany, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Henry Ford Health System

Detroit, Michigan, United States

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

Grand Rapids, Michigan, United States

Great Lakes Cancer Center Management Specialties

Grosse Point Woods, Michigan, United States

Cancer Management Specialists (No longer Recruiting)

Grosse Pointe Woods, Michigan, United States

St. Barnabas Health Care Center

Newark, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

July 1, 2004

Primary Completion Date

December 1, 2005

Completion Date

February 1, 2006

Last Updated

January 29, 2009

Enrollment

ACTUAL participants

Conditions

LeukemiaAcute Myeloid Leukemia

Interventions

Idarubincin and Amufostine (Ethyol)

DRUG

Idarubincin

DRUG

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NCT06311227

Recurrent Hairy Cell LeukemiaRecurrent Hairy Cell Leukemia Variant

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RECRUITINGPHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

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