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Chronic Myeloproliferative DisordersPhase 1/2NCT00054340

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

A Phase 1/2 study testing anti-thymocyte globulin, busulfan and cyclophosphamide in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 65 years
What is being tested?
anti-thymocyte globulin, busulfan and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Oct 2002to Sep 2006
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
anti-thymocyte globulin, busulfan, cyclophosphamide, cyclosporine, methotrexate
Keywords
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
Medical subject headings
Myeloproliferative Disorders, Graft vs Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Polycythemia Vera, Primary Myelofibrosis, Thrombocythemia, Essential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study startOct 2002
  3. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054340
Sponsor's protocol ID
1723.00
Other IDs
FHCRC-1723.00, CDR0000270397
Status last verified
May 2010
First submitted
5 Feb 2003
Last updated
14 May 2010
Results posted
No

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