Expired Study
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Seattle, Washington 98109


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.


Study summary:

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.


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


Study is Available At:


Original ID:

1723.00


NCT ID:

NCT00054340


Secondary ID:

FHCRC-1723.00


Study Acronym:


Brief Title:

Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For M


Official Title:

Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fred Hutchinson Cancer Research Center


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Supportive


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:H. Joachim Deeg, MD
Study Chair
Fred Hutchinson Cancer Research Center

Study Dates

Start Date:October 2002
Completion Date:September 2006
Completion Type:Actual
Verification Date:May 2010
Last Changed Date:May 12, 2010
First Received Date:February 5, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:anti-thymocyte globulin
Intervention Type:Drug
Name:busulfan
Intervention Type:Drug
Name:cyclophosphamide
Intervention Type:Drug
Name:cyclosporine
Intervention Type:Drug
Name:methotrexate
Intervention Type:Procedure
Name:allogeneic bone marrow transplantation
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fred Hutchinson Cancer Research Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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