Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00011934
First received: March 3, 2001
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow and may help a person's immune system recover from the side effects of the chemotherapy used in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation, chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.


Condition Intervention Phase
Leukemia
Biological: recombinant interferon alfa
Biological: sargramostim
Procedure: autologous bone marrow transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) and Autologous Bone Marrow Transplantation for Chronic Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Study Start Date: May 1998
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the preparative regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone marrow transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180, and interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myeloid leukemia (CML) by cytogenetic and/or molecular analyses No more than 10% blasts on blood and bone marrow morphology Philadelphia (Ph) chromosome positive Ph chromosome-negative CML allowed if evidence of the BCR-ABL rearrangement by molecular or FISH analyses or evidence of the P120 protein Duration of CML less than 3 years, unless cytogenetic remission to interferon has been achieved Failed to obtain and maintain a complete cytogenetic remission on a prior trial of interferon therapy Absence of detectable PH-negative cells in bone marrow or blood after 6 months of therapy Lack of a progressive increase in Ph-negative cells between 6 and 12 months of therapy Less than 50% Ph-negative cells after 12 months of therapy Absence of complete cytogenetic remission after 24 months of therapy Inability to tolerate prior interferon therapy No accelerated phase or blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML Concurrent enrollment on the busulfan and cyclophosphamide preparative regimen protocol

PATIENT CHARACTERISTICS: Age: 12 to 70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of intolerance to sargramostim (GM-CSF)

PRIOR CONCURRENT THERAPY: See Disease Characteristics

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00011934

Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: B. Douglas Smith, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00011934     History of Changes
Other Study ID Numbers: CDR0000068460, J9833, P30CA006973, JHOC-J9833, IMMUNEX-001.0683, JHOC-98051405, NCI-G01-1912
Study First Received: March 3, 2001
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Philadelphia chromosome negative chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014