Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

NCT00003758 | Unknown Phase 2

• 2 other identifiers: CDR0000066882EORTC-06956
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 16

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.

Conditions

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)

Interventions

cytarabine DRUG

idarubicin DRUG

allogeneic bone marrow transplantation PROCEDURE

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (16)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Medical School/University of Zagreb

Zagreb, 41000, Croatia

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Necker

Paris, 75743, France

Location

Ospedale San Eugenio

Rome, 00144, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5211 NL, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 ZA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Sint Joseph Ziekenhuis

Veldhoven, 5500 MB DB, Netherlands

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

Ibn-i Sina Hospital, Ankara Univeristy

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Basophilic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Cytarabine; Idarubicin; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Petra Muus, MD, PhD

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 3, 2004
• Study Start: December 1, 1998
• Last Updated: February 9, 2009

Record last verified: 2001-01

Locations

BE (4); FR (2); PT (1); IT (2); CR (2); TU (1); NL (4)