NCT00003148

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P75+ for phase_2 leukemia

Geographic Reach
6 countries

10 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

3.5 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) that has relapsed after prior treatment(s) Slowly progressing disease as defined by bone marrow blasts of greater than 5% and less than 30% confirmed by at least 2 marrow aspirates taken 2 weeks apart Must be in either: First relapse after autologous bone marrow or peripheral blood stem cell transplantation OR First or subsequent relapse either refractory to or not eligible for further conventional treatment regimens PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times normal Renal: Creatinine less than 2 times normal Cardiovascular: Ejection fraction normal Pulmonary: PLCO diffusion greater than 60% Other: No active uncontrolled infections No other progressive malignant disease Not a poor medical risk because of nonmalignant systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent indomethacin No other concurrent anticancer or investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Ospedale San Eugenio

Rome, 00144, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Study Officials

  • Roel Willemze, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 23, 2004

Study Start

October 1, 1997

Primary Completion

April 1, 2001

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

BE(2)AU(1)FR(2)CR(1)IT(2)NL(2)