NCT00086099

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

Completed Phase 1/Phase 2 Last updated 28 January 2009

What this trial tests

Phase 1/Phase 2 trial testing Idarubincin and Amufostine (Ethyol) in Leukemia in 54 participants. Completed in 1 February 2006.

Timeline

1 July 2004

Primary endpoint
1 December 2005

1 February 2006

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 July 2004
Primary completion	1 December 2005
Estimated completion	1 February 2006
Sites	19 locations across United States, Israel

Drugs / interventions tested

• Idarubincin and Amufostine (Ethyol) — full drug profile →
• Idarubincin — full drug profile →

Conditions studied

• Leukemia — all drugs for Leukemia →
• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

MedImmune LLC — full company profile →

Who can join

60 and older, any sex, with Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clinically significant hematologic and non-hematologic toxicities associated with idarubicin administration
  Time frame: 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
  Time frame: 30 days after last dose

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.