Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
|ClinicalTrials.gov Identifier: NCT00003335|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: anti-thymocyte globulin Drug: busulfan Drug: cyclosporine Drug: melphalan Drug: methylprednisolone Procedure: umbilical cord blood transplantation Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies|
|Study Start Date :||January 1998|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||January 2012|
- Biological: anti-thymocyte globulin
antithymocyte globulin IV for three days on days -3 to -1
- Drug: busulfan
If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.
- Drug: cyclosporine
Cyclosporine begin on day -2 and continue for 6 months.
- Drug: melphalan
melphalan IV for three days on days -4 to -2
- Drug: methylprednisolone
Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.
- Procedure: umbilical cord blood transplantation
On day 0, patients receive umbilical cord blood infusion.
- Radiation: radiation therapy
9 fractions of total body irradiation (TBI) on days -9 to -5
- rates of durable engraftment in patients [ Time Frame: 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.
- Event-free survival by clinical and pathological disease assessment [ Time Frame: at disease progression or death ]
- incidence of recurrent disease in patients post UCB transplant [ Time Frame: post transplant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003335
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Brenda W. Cooper, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|