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Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

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ClinicalTrials.gov Identifier: NCT00002771
Recruitment Status : Unknown
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Biological: recombinant interferon alfa Drug: busulfan Drug: cytarabine Drug: hydroxyurea Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: PROSPECTIVE CONTROLLED STUDY FOR THE OPTIMIZATION OF THERAPY IN CHRONIC MYELOID LEUKEMIA (CML): MULTICENTRIC STUDY FOR THE EVALUATION OF INTERFERON ALPHA VS ALLOGENIC BM TRANSPLANTATION WITH CHEMOTHERAPY IN CML
Study Start Date : January 1995


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed chronic myelogenous leukemia in chronic phase
  • Philadelphia chromosome- or bcr/abl-positive

    • Cytogenetic negativity (analyzed separately) allowed if at least 1 of the following criteria is met:

      • Malaise with decreased performance status
      • Weight loss of more than 10% within the past 6 months
      • Fever more than 38.5 C for 5 consecutive days
      • Symptomatic splenomegaly
      • Leukocyte count greater than 50,000/mm^3
      • Platelet count greater than 1,000,000/mm^3

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other medical condition that would reduce life expectancy
  • No other uncontrolled malignancy
  • Not pregnant
  • No other contraindication to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interferon

Chemotherapy:

  • No prior cytotoxic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified
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): NCT00002771


Locations
Germany
III Medizinische Klinik Mannheim
Mannheim, Germany, D-68135
Sponsors and Collaborators
German CML Study Group
Investigators
Study Chair: Ruediger Hehlmann, MD III. Medizinische Klinik Mannheim
More Information

ClinicalTrials.gov Identifier: NCT00002771     History of Changes
Other Study ID Numbers: GER-CML-3
CDR0000064743 ( Registry Identifier: PDQ (Physician Data Query) )
EU-95042
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2000

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive
Philadelphia chromosome negative chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Cytarabine
Busulfan
Idarubicin
Hydroxyurea
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors