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Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cytarabine
idarubicin
allogeneic bone marrow transplantation
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, adult acute monoblastic leukemia and acute monocytic leukemia (M5), childhood acute monoblastic leukemia and acute monocytic leukemia (M5), adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute eosinophilic leukemia, adult acute basophilic leukemia, adult acute megakaryoblastic leukemia (M7), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute erythroleukemia (M6), childhood acute eosinophilic leukemia, childhood acute basophilic leukemia, childhood acute megakaryocytic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0)

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • A.Z. St. Jan
  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • Medical School/University of Zagreb
  • University Hospital Rebro
  • Hotel Dieu de Paris
  • Hopital Necker
  • Ospedale San Eugenio
  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  • Groot Ziekengasthuis 's-Hertogenbosch
  • Leiden University Medical Center
  • University Medical Center Nijmegen
  • Sint Joseph Ziekenhuis
  • Hospital Escolar San Joao
  • Ibn-i Sina Hospital, Ankara Univeristy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 6, 2009
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003758
Brief Title
Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
Official Title
Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, adult acute monoblastic leukemia and acute monocytic leukemia (M5), childhood acute monoblastic leukemia and acute monocytic leukemia (M5), adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute eosinophilic leukemia, adult acute basophilic leukemia, adult acute megakaryoblastic leukemia (M7), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute erythroleukemia (M6), childhood acute eosinophilic leukemia, childhood acute basophilic leukemia, childhood acute megakaryocytic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Muus, MD, PhD
Organizational Affiliation
Universitair Medisch Centrum St. Radboud - Nijmegen
Official's Role
Study Chair
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
A.Z. St. Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Medical School/University of Zagreb
City
Zagreb
ZIP/Postal Code
41000
Country
Croatia
Facility Name
University Hospital Rebro
City
Zagreb
ZIP/Postal Code
41000
Country
Croatia
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Ospedale San Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Groot Ziekengasthuis 's-Hertogenbosch
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 ZA
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6252 HB
Country
Netherlands
Facility Name
Sint Joseph Ziekenhuis
City
Veldhoven
ZIP/Postal Code
5500 MB DB
Country
Netherlands
Facility Name
Hospital Escolar San Joao
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Ibn-i Sina Hospital, Ankara Univeristy
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

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