Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia - Full Text View

Sponsored by:	German CML Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002771

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 III

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy

Drug Information available for: Busulfan Cytarabine hydrochloride Idarubicin hydrochloride Idarubicin Interferon alfa-2a Interferon alfa-n1 Hydroxyurea Cytarabine Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

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

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:

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

No publications provided

Study ID Numbers:	CDR0000064743, GER-CML-3, EU-95042
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002771 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Philadelphia chromosome negative chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Study placed in the following topic categories:

Antimetabolites
Philadelphia Chromosome
Interferon-alpha
Interferon Type I, Recombinant
Immunologic Factors
Hydroxyurea
Hematologic Diseases
Interferons
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Immunosuppressive Agents

Angiogenesis Inhibitors
Antiviral Agents
Anti-Bacterial Agents
Leukemia
Idarubicin
Busulfan
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Bone Marrow Diseases
Interferon Alfa-2a
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Hydroxyurea
Hematologic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Leukemia
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

Nucleic Acid Synthesis Inhibitors
Cytarabine
Interferon-alpha
Antisickling Agents
Neoplasms by Histologic Type
Hematologic Diseases
Growth Substances
Interferons
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009