Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

Phase 2

• Conditions: Leukemia

• Registration Number: NCT00003758
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

Detailed Description

OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia.

OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 1999-11-01
• Status Verified: 2001-01
• Study First Submitted QC: 2004-06-02
• Study First Posted: 2004-06-03
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (16)

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy

Groot Ziekengasthuis 's-Hertogenbosch; 🇳🇱 's-Hertogenbosch, Netherlands

Sint Joseph Ziekenhuis; 🇳🇱 Veldhoven, Netherlands

Hotel Dieu de Paris; 🇫🇷 Paris, France

Hospital Escolar San Joao; 🇵🇹 Porto, Portugal

Ibn-i Sina Hospital, Ankara Univeristy; 🇹🇷 Ankara, Turkey

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Hopital Necker; 🇫🇷 Paris, France

A.Z. St. Jan; 🇧🇪 Brugge, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Medical School/University of Zagreb; 🇭🇷 Zagreb, Croatia

University Hospital Rebro; 🇭🇷 Zagreb, Croatia

Ospedale San Eugenio; 🇮🇹 Rome, Italy

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands