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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027924
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Drugs such as cyclosporine may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or myelodysplastic syndrome.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:   Anemia    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

Drug Information available for:   Methotrexate    Fludarabine    Fludarabine monophosphate    Cyclosporin    Cyclosporine    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors

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

Study Start Date:   October 2001

Detailed Description:

OBJECTIVES: I. Determine the incidence of nonrelapse mortality at 100 days after allogeneic peripheral blood stem cell transplantation in patients with chronic myelogenous leukemia (CML) or myelodysplastic syndrome (MDS) treated with fludarabine and busulfan. II. Determine the incidence of donor stem cell engraftment in patients treated with this regimen. III. Determine the incidence and severity of acute graft-vs-host disease in patients treated with this regimen. IV. Determine the incidence of persistent or recurrent CML or MDS in patients treated with this regimen. V. Determine the safety of this regimen in these patients.

OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -9 to -6 and oral busulfan every 6 hours on days -5 to -2. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine orally or IV twice daily on days -1 to 100 followed by a taper until day 180. Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.

  Eligibility
Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) (BCR/abl or Philadelphia (Ph) chromosome positive) Accelerated phase More than 10% and less than 30% myeloblasts and promyelocytes in marrow or peripheral blood Perturbations of white count, platelet count, or hematocrit uncontrolled by chemotherapy with busulfan or hydroxyurea Progressive splenomegaly refractory to chemotherapy Extramedullary tumor Presence of a nonconstitutional cytogenetic abnormality in addition to a single Ph chromosome, except for -Y Persistent unexplained fever or bone pain Blast phase More than 30% myeloblasts and promyelocytes in marrow or peripheral blood Remission after blast phase Less than 10% blasts in marrow and peripheral blood with a history of blast phase Any phase of CML if there is a contraindication to conditioning therapy with cyclophosphamide OR Diagnosis of myelodysplastic syndrome (MDS) with any of the following subtypes: Refractory anemia (RA) or RA with ringed sideroblasts (RARS) High-risk cytogenetics (i.e., monosomy 7 or complex abnormalities) RA with excess blasts (RAEB) Presence of 5-20% blasts in marrow and less than 5% blasts in peripheral blood RAEB in transformation 21-30% blasts in marrow OR more than 5% blasts in peripheral blood Chronic myelomonocytic leukemia Presence of no more than 20% blasts in marrow, less than 5% blasts in peripheral blood, and more than 1,000 monocytes/uL of peripheral blood Secondary acute myeloid leukemia arising from pre-existing MDS More than 30% blasts in marrow Any stage of MDS if there is a contraindication to conditioning therapy with cyclophosphamide Related or unrelated donor compatible for HLA-A, B, C, DRB1, and DQB1 antigens Mismatch for a single HLA-A, B, C, DRB1, and DQB1 allele within the same broad serotype (e.g., A*0101 vs 0102) or crossover group (e.g., A*0101 vs 0301) allowed

PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Not specified Life expectancy: Not severely limited by diseases other than malignancy Hematopoietic: See Disease Characteristics Hepatic: No hepatic disease AST no greater than 2 times normal Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% for age, weight, and height Cardiovascular: No cardiac insufficiency requiring treatment No symptomatic coronary artery disease Pulmonary: No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less than 70% predicted) No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60% predicted) Other: HIV negative Not pregnant or nursing

PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent growth factors during methotrexate administration

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027924

Locations
United States, Washington
Fred Hutchinson Cancer Research Center    
      Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Claudio Anasetti, MD     Fred Hutchinson Cancer Research Center    
  More Information


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

Study ID Numbers:   CDR0000069094, FHCRC-1519.00, NCI-H01-0082
First Received:   December 7, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00027924
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
blastic phase chronic myelogenous leukemia  
meningeal chronic myelogenous leukemia  
Philadelphia chromosome positive chronic myelogenous leukemia  
refractory anemia  
refractory anemia with ringed sideroblasts  
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
secondary acute myeloid leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Study placed in the following topic categories:
Philadelphia Chromosome
Blast Crisis
Cyclosporine
Precancerous Conditions
Chronic myelogenous leukemia
Clotrimazole
Chronic myelomonocytic leukemia
Refractory anemia
Miconazole
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Acute
Cyclosporins
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Methotrexate
Acute myelocytic leukemia
Myelodysplastic syndromes
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplasia
Tioconazole
Anemia
Myeloproliferative Disorders
Acute myelogenous leukemia
Fludarabine monophosphate
Leukemia, Myeloid
Folic Acid

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Antifungal Agents
Abortifacient Agents
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Disease
Neoplasms by Histologic Type
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 03, 2008




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