Clinical trial · Interventional
Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies
- 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)
This clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched related donors for children and young adults with hematologic malignancies who lack a suitably matched related or unrelated donor. The methodology will be one that has been successfully utilized in adult patients at Thomas Jefferson University.
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Donor Lymphocyte Infusion (DLI) | Biological | — | UNRESOLVED |
| Haploidentical Stem Cell Transplantation | Biological | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Haploidentical Stem Cell Transplantation
- description
- Subjects will receive pretransplantation conditioning of total-body irradiation (1,200 cGy delivered in 8 fractions over 4 days \[Days -9 through -6\] and cyclophosphamide (60 mg/kg IV daily x 2 on Days -3 and -2). Donor lymphocyte infusion will occur on day -6; donor CD34+ cells will be infused on Day 0.
- interventionNames
- Radiation: Radiation
- Drug: Cyclophosphamide
- Biological: Donor Lymphocyte Infusion (DLI)
- Biological: Haploidentical Stem Cell Transplantation
Primary outcomes (1)
- measure
- Hematopoietic engraftment
- timeFrame
- Day +30 post-transplantation
- description
- Absolute neutrophil count \>500/microliter x 3 consecutive days
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Acute lymphoblastic leukemia * Acue myelogenous leukemia * Myelodysplastic syndrome * Non-Hodgkin lymphoma * Chronic myelogenous leukemia * Adequate lung, liver, renal, cardiac function * Performance status \>70 * Available related donor who is mismatched at ≥ 2 HLA alleles Exclusion Criteria: * Available HLA-identical related donor * HIV positive * Active uncontrolled infection * Pregnancy * Performance status ≤70
References
Publications (1)
- BACKGROUNDGrosso D, Gaballa S, Alpdogan O, Carabasi M, Filicko-O'Hara J, Kasner M, Martinez-Outschoorn U, Wagner JL, O'Hara W, Rudolph S, Chervoneva I, Colombe B, Farley PC, Flomenberg P, Pro B, Sharma M, Shi W, Weiss M, Flomenberg N. A two-step approach to myeloablative haploidentical transplantation: low nonrelapse mortality and high survival confirmed in patients with earlier stage disease. Biol Blood Marrow Transplant. 2015 Apr;21(4):646-52. doi: 10.1016/j.bbmt.2014.12.019. Epub 2014 Dec 23. PMID 25542159