Clinical trial · Interventional
Unrelated Umbilical Cord Blood (UBC)Transplantation
Unrelated Umbilical Cord Blood (UCB) Transplantation
- 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)
Hematopoietic progenitor cell (HPC- primitive cells in the blood, bone marrow and umbilical cord that can restore the bone marrow) transplant can be a curative therapy for the treatment of hematologic malignancies (a disease of the bone marrow and lymph nodes). The source of cells used for the transplant comes from related (sibling) and in cases where there is no sibling match, from unrelated donors through the National Marrow Donor Program. The availability of a suitable donor can be a significant obstacle for patients who need a transplant but do not have a matched donor. Cord blood that has been harvested from an umbilical cord shortly after birth has a rich supply of cells needed for transplant. These stored cord bloods are now being used to transplant adults without a matched donor Advantages to using cord blood includes a readily available source of cells with no risk to the donor during the collection process, immediate source of cells in urgent situations (no lengthy donor work-up)and a reduction in infectious disease transmission to the recipient. One of the main disadvantages is the cord blood has a small number of cells needed for transplant. In an adult, usually two cords are needed and large recipients do not qualify because they need too many cells. This study will use two different preparative regimens (chemotherapy and radiation) followed by one or two umbilical cord units (UBC). The preparative regimen used will be chosen by the physician and is based on patient's age, disease and medical condition at the time of transplant. Multiple objectives for this study include disease-free and overall survival, treatment related mortality, rate of cells taking hold, and the incidence and severity of the transplant complication called graft versus host disease (GVHD).
Conditions
Conditions (9)
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 (ALL) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| Acute Myelogenous Leukemia (AML) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| umbilical cord blood (UCB) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplant
- description
- After a preparative regimen the patient will receive an infusion of one or two umbilical cord blood unit(s) (UBC). The UBC unit(s) will be thawed according to methods of Rubinstein et al. If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis. On day +30, +60, +100, +180, and +365 the chimeric status of patients will be interpreted by variable number tandem repeat (VNTR) analysis. Immune reconstitution (Digeorge Panel) will also be checked at these time points.
- interventionNames
- Genetic: umbilical cord blood (UCB)
Primary outcomes (1)
- measure
- Number of Participants With Engraftment
- timeFrame
- 60 days
- description
- Defined as neutrophil recovery associated with donor engraftment within the first 60 days of transplant
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 16-70 years * Available 4/6, 5/6, or 6/6 HLA antigen match (using A, B, and DRB1) cord blood unit. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky greater than or equal to 70%) * Serum bilirubin less than 2 x upper limit of normal * Serum creatinine less than 2 mg/dl * DLCO or FEV1 greater than or equal to 50% predicted * Left ventricular ejection fraction greater than or equal to 35% * no uncontrolled infection * If female, not pregnant * Informed consent given * No major organ dysfunction precluding transplantation. * One of the following malignancies or bone marrow failure syndromes: * Chronic myelogenous leukemia (CML) * Acute myelogenous leukemia (AML) * Myelodysplastic syndrome * Multiple myeloma * Hodgkin lymphoma * Non-Hodgkin lymphoma * Chronic lymphocytic leukemia (CLL) * Acute lymphocytic leukemia (ALL) * Severe Aplastic Anemia Exclusion Criteria: * Patient pregnant * Age less than 16, greater than 70 * ECOG performance status of greater than 2 (Karnofsky less than 70%) * Psychiatric disorder or mental deficiency of the patient sufficiently severe as to make compliance with the BMT treatment unlikely, or making informed consent impossible * Serum bilirubin greater than or equal to 2 x upper limit of normal, transaminases greater than 3 x upper limit of normal * Serum creatinine greater than or equal to 2 mg/dl * DLCO less than 50% predicted * Left ventricular ejection fraction less than 35% * Major anticipated illness or organ failure incompatible with survival from Bone Marrow Transplant (BMT)
References
Publications (0)
Data not yet available