Myelodysplastic Syndrome Clinical Trial
Official title:
A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies
Verified date | May 2018 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is compare the efficacy of haplo-cord transplant (investigational
arm) with that of a more commonly used procedure in which only the cells contained in one or
two umbilical cords are infused (standard arm).
We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast
engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus
host disease, low frequency of delayed opportunistic infections, reduced transfusion
requirements, shortened length of hospital stay and promising long term outcomes. We also
hypothesize that umbilical cord blood selection can prioritize matching and better matched
donors can be identified rapidly for most subjects.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 29, 2015 |
Est. primary completion date | April 29, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject must have a histologically or cytologically confirmed diagnosis of: Acute Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphocytic Leukemia Lymphoma (Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma) 2. Must be > 18 years of age 3. Subject is likely to benefit from allogeneic transplant in the opinion of the transplant physician 4. An human leukocyte antigen (HLA)-identical related or unrelated donor cannot be identified within an appropriate time frame 5. Karnofsky Performance Status (KPS) of > 80 6. Subject has acceptable organ and marrow function as defined below: Serum bilirubin < 2.0mg/dL ALT(SGPT) 3 X upper limit of normal Creatinine Clearance > 50 mL/min as estimated by the modified MDRD equation.18 7. Ability to understand and the willingness to sign a written informed consent document. 8. A preliminary search has identified both: 1. Appropriate umbilical cords for a single, or if necessary a double umbilical cord blood (UCB) transplant AND 2. An appropriate single UCB as well as an appropriate haplo donor for haplo-cord transplant Exclusion Criteria: 1. Myeloproliferative disorders, hemoglobinopathies, severe aplastic anemia or any diagnosis not listed under 3.1.1 2. Life expectancy is severely limited by concomitant illness or uncontrolled infection 3. Subjects with severely decreased Left Ventricular Ejection Fraction (LVEF) or impaired pulmonary function tests (PFTs) 4. Subject has evidence of chronic active hepatitis or cirrhosis 5. Subject is HIV-positive 6. Subject is pregnant or lactating. - |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Neutrophil Engraftment After Combined Haplo-identical Cord With That of Umbilical Cord Blood Transplantation. | No patients completed this study and are therefore inevaluable. Subject data not evaluable for the outcome measure time frame. Subject data only evaluable up to month 3. | estimation of 24 months to determine engraftment rates for all subjects | |
Secondary | Platelet Recovery After Transplant Regimens | No patients completed this study and are therefore inevaluable | estimation of 24 months to determine platelet recovery for all subjects | |
Secondary | Transfusion Requirements After Haplo-identical Umbilical Cord Blood Transplant Versus Double Umbilical Cord Blood Transplant | estimation of 24 months to determine transfusion requirements of all subjects | ||
Secondary | Transplant-related Mortality (TRM), Relapse Rate, Survival and Progression Free Survival | estimation of 24 months to obtain survival info between subjects | ||
Secondary | Incidence of Acute and Chronic GVHD | estimation of 24 months to obtain GVHD data on all subjects | ||
Secondary | Severity of Opportunistic Infections | estimation of 24 months to obtain infection data on all subjects |
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