- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003148
Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Phase II Study of the Efficacy of rH Interleukin-2 in Patients With Slowly Progressing Acute Myelogenous Leukemia (AML) and With Limited Bone Marrow Blastosis After Autologous Stem Cell Transplantation or Chemotherapy
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Innsbruck, Austria, A-6020
- Innsbruck Universitaetsklinik
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Zagreb, Croatia, 41000
- University Hospital Rebro
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Paris, France, 75181
- Hotel Dieu de Paris
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Rome, Italy, 00161
- Azienda Policlinico Umberto Primo
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Rome, Italy, 00144
- Ospedale San Eugenio
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Leiden, Netherlands, 2300 CA
- Leiden University Medical Center
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Nijmegen, Netherlands, NL-6252 HB
- University Medical Center Nijmegen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Roel Willemze, MD, PhD, Leiden University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-06964
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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