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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002701
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: November 2006
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002701     History of Changes
Other Study ID Numbers: CDR0000064499, EORTC-06952, ITA-GIMEMA-AIEOP-1
Study First Received: November 1, 1999
Last Updated: September 19, 2013
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:
Leukemia, Promyelocytic, Acute
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Methotrexate
Mitoxantrone
Idarubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
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
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014