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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002771
First received: November 1, 1999
Last updated: August 1, 2013
Last verified: July 2000
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Estimated Enrollment: 750
Study Start Date: January 1995
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
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: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002771     History of Changes
Other Study ID Numbers: GER-CML-3, CDR0000064743, EU-95042
Study First Received: November 1, 1999
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

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
Interferon-alpha
Cytarabine
Interferons
Busulfan
Hydroxyurea
Idarubicin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antisickling Agents
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014