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

This study is ongoing, but not recruiting participants.

First Received: November 1, 1999 Last Updated: February 6, 2009 History of Changes

Sponsor:	European Organization for Research and Treatment of Cancer
Collaborator:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002701

Purpose

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.

Condition	Intervention	Phase
Leukemia	Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: thioguanine Drug: tretinoin Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LEUKEMIA

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	750
Study Start Date:	October 1995

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002701

Show 71 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Study Chair:	Petra Muus, MD, PhD	Universitair Medisch Centrum St. Radboud - Nijmegen
Study Chair:	Franco Mandelli, MD	Azienda Policlinico Umberto Primo

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000064499, EORTC-06952, ITA-GIMEMA-AIEOP-1
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002701 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Neoplasm, Residual
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
6-Mercaptopurine
Cyclophosphamide
Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Keratolytic Agents
Leukemia

Neoplastic Processes
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Abortifacient Agents
Leukemia, Promyelocytic, Acute
Methotrexate
Analgesics
Dermatologic Agents
Alkylating Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Cytarabine
Neoplasms by Histologic Type
Thioguanine

ClinicalTrials.gov processed this record on November 09, 2009