Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
- Conditions
- Graft Versus Host DiseaseLeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases
- Registration Number
- NCT00003335
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.
PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.
- Detailed Description
OBJECTIVES:
* Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation.
* Determine the incidence of graft-versus-host-disease in this setting.
* Describe the incidence of recurrent disease in these patients post UCB transplant.
* Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients.
* Determine specifically whether larger recipients can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment.
OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to treatment.
Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months.
Patients are followed at least monthly for 1 year, then every 6 months for the second year, and then annually thereafter.
PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method rates of durable engraftment in patients day 42 The primary study end point will be hematologic engraftment. Engraftment is defined as achieving ANC larger than or equal to 500 ul/mm3 of donor origin for three consecutive measurements on different days by day +42.
- Secondary Outcome Measures
Name Time Method Event-free survival by clinical and pathological disease assessment at disease progression or death incidence of recurrent disease in patients post UCB transplant post transplant
Trial Locations
- Locations (1)
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States