Clinical trial · Interventional
Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies
A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
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 Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS® CD34 Reagent System | Device | — | UNRESOLVED |
| Double Umbilical Cord Blood Transplantation | Procedure | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Haplo-Identical Cord Transplantation | Procedure | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Rabbit ATG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Haplo-Cord SCT
- description
- The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
- interventionNames
- Device: CliniMACS® CD34 Reagent System
- Drug: Fludarabine
- Drug: Melphalan
- Drug: Rabbit ATG
- Procedure: Haplo-Identical Cord Transplantation
- type
- ACTIVE_COMPARATOR
- label
- UCB SCT
- description
- For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available