Clinical trial · Interventional
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment
NCT01854567CI-TRIAL-00045685completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of one MPC expanded cord unit and one unexpanded cord unit | Biological | — | UNRESOLVED |
| Infusion of two unexpanded cord blood units. | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- description
- Infusion of one MPC expanded cord unit and one unexpanded cord unit.
- interventionNames
- Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Infusion of two unexpanded cord blood units.
- interventionNames
- Biological: Infusion of two unexpanded cord blood units.
Primary outcomes (1)
- measure
- Time to Neutrophil and Platelet Engraftment
- timeFrame
- 100 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.