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Myelodysplastic/Myeloproliferative Syndromes

Treosulfan and Fludarabine + Low-Dose TBI as Transplant Conditioning for MDS Patients (2524)
A Randomized Phase II Multi-Center Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients with Myelodysplastic Syndrome (MDS)
Status Conditions Phase Study ID
Recruiting Myelodysplastic Syndrome Phase II 2524
NCT01894477
Summary

This randomized phase II trial studies how well treosulfan and fludarabine phosphate with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.


Investigator
Joachim Deeg, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia (CMML), and MDS/myeloproliferative neoplasm (MPN) unclassifiable syndromes)
  • With Karnofsky index or Lansky Play-Performance scale > 70% on pre-transplant evaluation
  • Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
  • Patients with previous autologous or allogeneic HCT are allowed to enroll
  • DONOR: Human leukocyte antigen (HLA)-identical related donors or
  • DONOR: Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for one HLA allele is allowed
  • DONOR: Donors able to undergo peripheral blood stem cell collection or bone marrow harvest
  • DONOR: Donors in good general health, with a Karnofsky or Lansky play performance score > 90%
  • DONOR: Donors able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
Exclusions (conditions that would prevent participation in this study)
  • Receiving umbilical cord blood
  • With impaired cardiac function as evidenced by ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
  • With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) < 70 mm Hg and diffusing capacity of the lungs for carbon monoxide (DLCO) < 70% of predicted or pO2 < 80 mm Hg and DLCO < 60% of predicted; or receiving supplementary continuous oxygen
  • With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper limit of normal or dialysis-dependent
  • With hepatic dysfunction as evidenced by total bilirubin > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
  • With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
  • With active infectious disease requiring deferral of conditioning, as recommended by an infectious disease specialist
  • With human immunodeficiency virus (HIV)-positivity or active infectious hepatitis
  • With central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy, cranial irradiation or both prior to initiating conditioning (day -6)
  • With life expectancy severely limited by diseases other than malignancy
  • Women who are pregnant or lactating
  • With known hypersensitivity to treosulfan or fludarabine
  • Receiving another experimental drug within 4 weeks before initiation of conditioning (day -6)
  • Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
  • DONOR: Individuals deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
  • DONOR: Individuals who are HIV-positive
  • DONOR: Individuals with active infectious hepatitis
  • DONOR: Females with a positive pregnancy test
  • DONOR: Persons unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
Last Updated
January 13, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.