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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002701
First Posted: April 11, 2003
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:
National Cancer Institute (NCI)
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002701


  Show 71 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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

ClinicalTrials.gov Identifier: NCT00002701     History of Changes
Other Study ID Numbers: CDR0000064499
EORTC-06952
ITA-GIMEMA-AIEOP-1
First Submitted: November 1, 1999
First Posted: April 11, 2003
Last Update Posted: September 20, 2013
Last Verified: November 2006

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
adult acute promyelocytic leukemia (M3)

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Cyclophosphamide
Methotrexate
Cytarabine
Busulfan
6-Mercaptopurine
Etoposide
Mitoxantrone
Idarubicin
Tretinoin
Thioguanine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites