Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia

NCT00002701 | Unknown Phase 3

• 3 other identifiers: CDR0000064499EORTC-06952ITA-GIMEMA-AIEOP-1
• Study Type: interventional
• Target: 750
• Locations: 9 countries
• Sites: 71

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia; adult acute promyelocytic leukemia (M3)

Interventions

busulfan DRUG

cyclophosphamide DRUG

cytarabine DRUG

etoposide DRUG

idarubicin DRUG

mercaptopurine DRUG

methotrexate DRUG

mitoxantrone hydrochloride DRUG

thioguanine DRUG

tretinoin DRUG

allogeneic bone marrow transplantation PROCEDURE

autologous bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 16 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Newly diagnosed acute promyelocytic leukemia * Must have promyelocyte-retinoic acid receptor alpha transcript at disease presentation PATIENT CHARACTERISTICS: Age: * 16 to 74 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 3 times upper limit of normal (ULN) * AST no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN Renal: * Creatinine no greater than 2.5 mg/dL Cardiovascular: * No cardiac contraindication to anthracycline chemotherapy Other: * No active serious infection not controlled by antibiotics * No severe concurrent psychiatric disease * No other malignancy except basal cell carcinoma * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent cytotoxic chemotherapy Endocrine therapy: * Prior corticosteroids for leukemia allowed Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * No prior antileukemic therapy

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
• Gruppo Italiano Malattie EMatologiche dell'Adulto: collaborator

Study Sites (71)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

C.H.U. Saint-Pierre

Brussels (Bruxelles), 1000, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

CHU Sart-Tilman

Liège, B-4000, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Medical School/University of Zagreb

Zagreb (Agram), 41000, Croatia

Location

Onkologicka Klinka A Onkologicka Lab

Prague, 128 08, Czechia

Location

Centre Hospitalier Regional de Lille

Lille, 59037, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Necker

Paris, 75743, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Klinikum Duisburg

Duisburg, D-47055, Germany

Location

Klinikum Grosshadern

Munich (Muenchen), D-81377, Germany

Location

Ospedale Civile Alessandria

Alessandria, I-15100, Italy

Location

Ospedale Torrette University Ancona

Ancona, 60020, Italy

Location

Ospedale Civile Avellino

Avellino, Italy

Location

Universita Degli Studi di Bari Policlinico

Bari, 70124, Italy

Location

Ospedale Regionale A. Di Summa

Brindisi, I-72100, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09124, Italy

Location

Ospedale Ferrarotto

Catania, 95124, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Centro Trapianti di Midollo Osseo

Cremona, 26100, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Policlinico di Careggi

Firenze (Florence), 50134, Italy

Location

Ospedali Riuniti Foggia

Foggia, 71100, Italy

Location

Ospedale S. Antonio Abate

Gallarate Varese, 21013, Italy

Location

Ospedale San Martino/Cliniche Universitarie Convenzionate

Genoa (Genova), 16132, Italy

Location

Ospedale Gen. Provinciale Santa Maria Goretti

Latina, 04100, Italy

Location

Ospedale Maggiore Lodi

Lodi, I-20075, Italy

Location

Istituto Scientifico H.S. Raffaele

Milan, 20132, Italy

Location

Ospedale Maggiore Ca Granda

Milano (Milan), 20162, Italy

Location

Ospedale Di Montefiascone

Montefiascone, I-01027, Italy

Location

Azienda Ospedaliera "A. Cardarelli"

Naples (Napoli), 80127, Italy

Location

Federico II University Medical School

Naples (Napoli), 80131, Italy

Location

Ospedale S. Gennora USL 42

Naples (Napoli), 80136, Italy

Location

Ospedale Nuovo Pellegrini

Naples (Napoli), 80144, Italy

Location

Ospedale San Francesco

Nuoro, 08100, Italy

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

Policlinico - Cattedra di Ematologia

Palermo, 90100, Italy

Location

Ospedale Cervello

Palermo, 90146, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Policlinico Monteluce

Perugia, 06122, Italy

Location

Ospedale San Salvatore

Pesaro, I-61100, Italy

Location

Ospedale Civile Pescara

Pescara, 65100, Italy

Location

Ospedale San Carlo

Potenza, 85100, Italy

Location

Ospedale San Eugenio

Rome, 00144, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Istituto di Ematologia Universita - University di Sassari

Sassari, 07100, Italy

Location

Ospedal SS Annunziata

Taranto, 74100, Italy

Location

Cattedra di Immunologia Clinica

Turin (TO), 10128, Italy

Location

Ospedale Molinette

Turin (Torino), 10126, Italy

Location

Leyenburg Ziekenhuis

's-Gravenhage (Den Haag, the Hague), 2545 CH, Netherlands

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5211 NL, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Ibn-i Sina Hospital, Ankara University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Promyelocytic, Acute

Interventions

Busulfan; Cyclophosphamide; Cytarabine; Etoposide; Idarubicin; Mercaptopurine; Methotrexate; Mitoxantrone; Thioguanine; Tretinoin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Sulfhydryl Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Anthraquinones; Anthrones; Anthracenes; Quinones; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Therapeutics

Study Officials

• Petra Muus, MD, PhD

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

• Franco Mandelli, MD

  Azienda Policlinico Umberto Primo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 11, 2003
• Study Start: October 1, 1995
• Last Updated: September 20, 2013

Record last verified: 2006-11

Locations

AU (1); FR (7); NL (7); BE (9); CZ (1); IT (41); DE (2); CR (2); TU (1)