Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant 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 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025402
First received: October 11, 2001
Last updated: December 17, 2013
Last verified: July 2002
  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 3

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
  Show Detailed Description

  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
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: 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:
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: December 17, 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
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
Cytarabine
Interferons
Busulfan
Cyclophosphamide
Lenograstim
Etoposide
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
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014