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Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder

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: NCT00054340
  Purpose

RATIONALE: Combining antithymocyte globulin with combination chemotherapy before donor peripheral stem cell transplantation may reduce the chance of developing graft-versus-host disease following transplantation.

PURPOSE: Phase I/II trial to study the effectiveness of combining antithymocyte globulin with busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for myelodysplastic syndrome or other myeloproliferative disorder.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Drug: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase I
Phase II

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

Drug Information available for:   Cyclophosphamide    Methotrexate    Cyclosporine    Cyclosporin    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Open Label
Official Title:   Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders

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

Study Start Date:   October 2002

Detailed Description:

OBJECTIVES:

  • Determine the incidence of acute graft-vs-host disease (GVHD) requiring therapy in patients with myelodysplastic syndromes or myeloproliferative disorders treated with busulfan, cyclophosphamide, and anti-thymocyte globulin prior to transplantation with filgrastim (G-CSF)-mobilized peripheral blood stem cells (or bone marrow) from related or unrelated donors.
  • Determine the incidence of relapse and relapse-free survival in patients treated with this regimen.
  • Determine the incidence of non-relapse mortality by day 100 and 1 year posttransplantation in patients treated with this regimen.
  • Determine the incidence of Epstein-Barr virus reactivation, infections, and chronic GVHD in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of anti-thymocyte globulin.

  • Conditioning and graft-vs-host disease (GVHD) prophylaxis: Patients receive oral busulfan every 6 hours on days -7 to -4 (16 doses), cyclophosphamide IV on days -3 and -2, and anti-thymocyte globulin IV over 3 hours on days -3, -2, and -1.

Cohorts of 15 patients receive adjusted doses of anti-thymocyte globulin to determine the optimal dose at which Epstein-Barr virus (EBV) activation and GVHD are reduced. The optimal dose is the dose at which 2 consecutive cohorts receive the same regimen.

  • Stem cell transplantation: Patients undergo peripheral blood stem cell (PBSC) or bone marrow transplantation on day 0.
  • Posttransplantation GVHD prophylaxis: Patients receive cyclosporine IV continuously on days -1 to 4 and then orally twice daily until day 180. Patients also receive methotrexate on days 1, 3, 6, and 11.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study within 2 years.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Myelodysplastic syndromes (including those that have evolved to acute myeloid leukemia)
    • Myeloproliferative disorders

      • No chronic myelogenous leukemia
    • Other diseases eligible for conditioning with targeted busulfan, cyclophosphamide, and anti-thymocyte globulin that are not candidates for other studies
  • Available related or unrelated donor compatible for HLA-A, -B, -C, DRB1, and DQB1

    • A single allele mismatch at HLA-A, -B, -C, or DRB1 is allowed

PATIENT CHARACTERISTICS:

Age

  • 65 and under

Performance status

  • Not specified

Life expectancy

  • No severe limitation due to other diseases

Hematopoietic

  • Not specified

Hepatic

  • AST no greater than 2 times normal
  • No hepatic disease

Renal

  • Creatinine no greater than 2 times upper limit of normal OR
  • Creatinine clearance at least 50% for age, gender, and weight

Cardiovascular

  • No cardiac insufficiency requiring treatment
  • No symptomatic coronary artery disease

Pulmonary

  • No severe or mild hypoxemia

    • pO_2 at least 70 mm Hg and DLCO at least 70% of predicted OR
    • pO_2 at least 80 mm Hg and DLCO at least 60% of predicted

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No growth factors given posttransplantation concurrently with methotrexate immunosuppression

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054340

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

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

Investigators
Study Chair:     H. Joachim Deeg, 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:   CDR0000270397, FHCRC-1723.00
First Received:   February 5, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00054340
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
graft versus host disease  
polycythemia vera  
chronic idiopathic myelofibrosis  
essential thrombocythemia  
untreated adult acute myeloid leukemia  
recurrent adult acute myeloid leukemia  
recurrent childhood acute myeloid leukemia  
untreated childhood acute myeloid leukemia and other myeloid malignancies  
de novo myelodysplastic syndromes  
previously treated myelodysplastic syndromes  
secondary myelodysplastic syndromes
chronic eosinophilic leukemia
chronic neutrophilic leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)
childhood myelodysplastic syndromes

Study placed in the following topic categories:
Polycythemia
Cyclosporine
Precancerous Conditions
Clotrimazole
Graft versus host disease
Miconazole
Cyclophosphamide
Leukemia, Myeloid, Acute
Cyclosporins
Leukemia
Preleukemia
Hemorrhagic thrombocythemia
Chronic Myeloproliferative Disorders
Thrombocytosis
Neoplasm Metastasis
Methotrexate
Thrombocythemia, Hemorrhagic
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute myelocytic leukemia
Essential thrombocytosis
Polycythemia Vera
Myelodysplastic syndromes
Myelofibrosis
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Tioconazole
Myeloproliferative Disorders
Acute myelogenous leukemia

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
Neoplasms by Histologic Type
Disease
Immune System Diseases
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 November 20, 2008




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