Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Phase 2

Completed

• Conditions: Leukemia

• Registration Number: NCT00003148
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment.

Detailed Description

OBJECTIVES: I. Assess the therapeutic activity of interleukin-2 (IL-2) in patients with slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first relapse after autologous bone marrow or peripheral blood stem cell transplantation, or with more advanced disease (i.e., refractory to chemotherapy regimens). II. Characterize the acute side effects of IL-2 in these patients.

OUTLINE: This is an open label, nonrandomized, multicenter study. Patients are stratified into two categories of prior failed treatments (first relapse after autologous bone marrow or peripheral blood stem cell transplantation vs first or subsequent relapse either refractory to or not eligible for further conventional treatment). Interleukin-2 (IL-2) is administered as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the first cycle. When the individual maximum tolerated dose (MTD) has been determined, 3 more cycles are given at the MTD. There are 3 days of rest between each treatment cycle. After the induction phase, maintenance cycles of IL-2 are administered starting 4 weeks after the last induction treatment. Maintenance cycles of IL-2 are administered subcutaneously on 5 consecutive days every 4 weeks for 2 years, and subsequently every other month for a maximum of 3 years. Treatment continues until disease progression or unacceptable toxicity for a maximum of 5 years. Patients are followed every 4 weeks during the first 2 years, then every 8 weeks during the next 3 years or until documented progression, and then every 3 months until death.

PROJECTED ACCRUAL: A maximum of 86 (57 transplanted; 29 patients nontransplanted) patients will be accrued into this study within 2 years.

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-04
• Study First Submitted QC: 2004-04-22
• Study First Posted: 2004-04-23
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

University Hospital Rebro; 🇭🇷 Zagreb, Croatia

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Ospedale San Eugenio; 🇮🇹 Rome, Italy

Hotel Dieu de Paris; 🇫🇷 Paris, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Azienda Policlinico Umberto Primo; 🇮🇹 Rome, Italy