Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia - Full Text View

Sponsor:	III. Medizinische Klinik Mannheim
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00025402

Purpose

RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether chemotherapy is more effective with or without interferon alfa and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia.

PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy, biological therapy, and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia.

Condition	Intervention	Phase
Leukemia	Biological: filgrastim Biological: recombinant interferon alfa Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: hydroxyurea Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase

Resource links provided by NLM:

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

Primary Outcome Measures:

Survival [ Designated as safety issue: No ]
Frequency, time-point, and duration of hematologic and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCL-ABL-positive cells [ Designated as safety issue: No ]
Correlation of quality of hematological and cytogenetic remission with survival time [ Designated as safety issue: No ]
Course of the terminal phase [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time [ Designated as safety issue: No ]
Effect of early vs late high-dose therapy and autografting on feasibility, toxicity and survival times [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	July 1997

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic myelogenous leukemia in chronic phase
- Previously untreated
Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria:
- Impaired health status with reduced exercise tolerance
- Spleen-related symptoms in cases of splenomegaly
- Weight loss greater than 10% in 6 months
- Fever greater than 38.5 degrees C on 5 consecutive days
- Clinically relevant bone pain
- Leukocytosis greater than 5,000/mm^3
- Thrombocytosis greater than 100,000/mm^3

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Not specified

Renal:

Not specified

Other:

No other concurrent malignancy that is likely to require treatment during study or that is likely to reduce life expectancy
No severe concurrent disease or other cause that would preclude study
Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior interferon

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025402

Show 188 Study Locations

Sponsors and Collaborators

III. Medizinische Klinik Mannheim

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

ClinicalTrials.gov Identifier:	NCT00025402 History of Changes
Other Study ID Numbers:	CDR0000068957, III-MK-CML-3A, EU-20118
Study First Received:	October 11, 2001
Last Updated:	June 4, 2011
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
atypical chronic myeloid leukemia, BCR-ABL1 negative

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
Interferon Alfa-2a
Cytarabine
Interferons
Busulfan
Cyclophosphamide
Lenograstim

Etoposide
Hydroxyurea
Idarubicin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012