Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematolog… (NCT00796068) | Clinical Trial Compass
CompletedPhase 2
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
United States130 participantsStarted 2009-02-24
Plain-language summary
This phase II trial studies how well giving treosulfan together with fludarabine phosphate and total-body irradiation (TBI) works in treating patients with hematological cancer who are undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CsA) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.
Who can participate
Age range65 Years
SexALL
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Inclusion Criteria:
* Acute myeloid leukemia/acute lymphoblastic leukemia, including biphenotypic acute leukemia or mixed-lineage leukemia: Must have \< 5% morphologic marrow blasts in an evaluable marrow sample (\> 25% of normal cellularity for age collected less than one month prior to start of conditioning; patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible; reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures; these patients must be discussed with the principal investigator prior to enrollment; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible with principal investigator (PI) approval
* Myelodysplastic syndrome (MDS): Any 2001 World Health Organization (WHO) classification subtype; refractory anemia with excess blasts (RAEB)-2 patients may proceed directly to transplant, but may also be considered for induction chemotherapy before transplant; patients with \>= 20% morphologic marrow blasts require induction therapy to reduce morphologic marrow blasts below 5% before transplant
* Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients mus…
What they're measuring
1
Number of Participants With Graft Failure/Rejection
Timeframe: Up to 100 days
2
Number of Participants With Secondary Graft Failure
Timeframe: Up to 2 years
3
Number of Patients With Non-relapse Mortality (NRM)