Clinical trial · Interventional
VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies
Phase I Study of Valproic Acid Expanded Cord Blood Stem Cells as an Allogeneic Donor Source for Adults With Hematological Malignancies
NCT03885947CI-TRIAL-00051958completedPhase 1ClinicalTrials.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)
In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA) expanded cord blood stem cells defined by the lack of serious infusion reactions or graft failure in patients with hematological malignancies undergoing umbilical cord blood transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet engraftment as well as transplant related outcomes such as graft versus host disease (GVHD), treatment related mortality (TRM), and overall survival (OS).
Conditions
Conditions (6)
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 Leukemia in Remission | Acute Leukemia | CURATED_BROADER | 0.78 |
| Acute Lymphoblastic Leukemia in Remission | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cord blood stem cells | Biological | — | UNRESOLVED |
| cytoxan | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| TBI | Biological | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
| Valproic Acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VPA expanded cord blood stem cells
- description
- CD34 selected VPA expanded umbilical cord blood cells used in combination with or without unmanipulated umbilical cord blood for patients with hematological malignancies undergoing allogeneic stem cell transplantation. VPA expanded cord blood stem cells in patients with hematological malignancies undergoing allogeneic stem cell transplantation
- interventionNames
- Biological: Cord blood stem cells
- Drug: Valproic Acid
- Drug: Fludarabine
- Drug: cytoxan
- Drug: Thiotepa
- Biological: TBI
Primary outcomes (2)
- measure
- Number of Infusion Reaction
- timeFrame
- 42 days
- description
- Safety as measured by the incidence of infusion related reactions.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Disease criteria: Patients with the following hematological malignancies: * Acute Myeloid Leukemia (AML) in complete remission (CR) * Acute Lymphoblastic Leukemia (ALL) in complete remission (CR) * Myelodysplastic Syndrome (MDS) requiring intensive chemotherapy * Non-Hodgkin lymphoma in complete or partial remission * Hodgkin lymphoma in complete or partial remission Age Criteria: \- 18 years up to 65 years. Organ Function and Performance Status Criteria: \- Performance status score: Karnofsky Score ≥60 Adequate major organ function defined as: * Left ventricular ejection fraction ≥40% * Pulmonary function test demonstrating DLCO ≥50% predicted and corrected for hemoglobin * Serum creatinine ≤ 2 mg/dL * Transaminases ≤ 3x ULN * Bilirubin ≤3x ULN except for in case of Gilbert's syndrome or ongoing hemolysis * Ability to understand and the willingness to sign a written informed consent document Donor availability: -Lack of suitable HLA matched related or unrelated donor available within 30 days or less if BMT is urgent in the opinion of the transplant physician. Exclusion Criteria: * Progressive, persistent disease or active malignancy * Greater than 10% blasts on bone marrow biopsy in patients with MDS * Chemotherapy naïve * History of myelofibrosis * Presence of Bone Marrow Fibrosis grade 2/3 * Presence of donor specific anti-HLA antibodies against available UCB units at A, B, C or DR loci, with a mean fluorescence intensity (MFI)\>1000 * History of prior allogeneic stem cell transplantation * Uncontrolled viral, bacterial or fungal infection * History of HIV infection * Presence of active CNS disease at the time of transplantation * Pregnant or breastfeeding female * Inability or unwillingness to use effective birth control.
References
Publications (0)
Data not yet available
No reference posted for this study.