P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With He⦠(NCT01854567) | Clinical Trial Compass
CompletedPhase 3
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
United States49 participantsStarted 2013-08
Plain-language summary
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
Who can participate
Age range65 Years
SexALL
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Inclusion Criteria:
* Patient must have one of the following:
* Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
* Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
* Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.
* Hodgkin's disease: High risk subjects with responsive disease after first relapse.
* Minimum Karnofsky Scale
* Subject must weigh at least 20 kg
* Up to 65 years of age
* Adequate major organ system function
Exclusion Criteria:
* Pregnancy and/or lactating
* Suitable, 6/6 HLA matched related sibling donor available
* Previous participation in a stem cell study within last 30 days