Clinical trial · Interventional
Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative Regimen
- 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)
In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical cord blood transplantation (UCBT) using a myeloablative preparative regimen. The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disorder Related to Transplantation | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematopoietic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preparative Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Research Arm
- description
- Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit. Intervention: Preparative Regimen
- interventionNames
- Drug: Preparative Regimen
- type
- OTHER
- label
- Observation Arm
- description
- Patients requiring two UCB units will be eligible for UCBT01 on the observational arm. Intervention: Preparative Regimen
- interventionNames
- Drug: Preparative Regimen
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age less than or equal to 21 years old. * Has a partially HLA-matched single or double UCB product * High-risk hematologic malignancy. * High risk ALL in CR1, ALL in High risk CR2, ALL in CR3 or subsequent. * AML in high risk CR1, AML in CR2 or subsequent * AML in first relapse with \< 25% blasts in BM * Therapy related AML, with prior malignancy in CR \> 12mo * MDS, primary or secondary * NK cell, biphenotypic, or undifferentiated leukemia in CR1 or subsequent. * CML in accelerated phase, or in chronic phase with persistent molecular positivity or intolerance to tyrosine kinase inhibitor. * Hodgkin lymphoma in CR2 or subsequent after failure of prior autologous HCT, or unable to mobilize stem cells for autologous HCT. * Non-Hodgkin lymphoma in CR2 or subsequent after failure of prior autologous HCT, or unable to mobilize stem cells for autologous HCT. * JMML * All patients with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for study. Patient must fulfill pre-transplant evaluation: * Cardiac shortening fraction ≥ 26%. * Creatinine clearance ≥ 70 ml/min/1.73m2. * Forced vital capacity (FVC) ≥ 50% of predicted value or pulse oximetry ≥ 92% on room air. * Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 70 * Bilirubin ≤ 2.5 mg/dL. * Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age. * Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age. Exclusion Criteria: * Patient has a suitable MSD, volunteer MURD, or KIR mismatched haploidentical donor available in the necessary time for stem cell donation. * Patient has any other active malignancy other than the one for which HCT is indicated. * Patient had a prior allogeneic HCT * Patient had an autologous HCT within the previous 12 months. * Patient is pregnant as confirmed by positive serum or urine pregnancy test within 14 days prior to enrollment. * Patient is lactating * Patient has Down Syndrome * Patient has a current uncontrolled bacterial, fungal, or viral infection per the judgment of the PI.
References
Publications (0)
Data not yet available