Clinical trial · Interventional
Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation
CD45A-Depleted Haploidentical Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator's decision.
Summary
Brief summary (as posted)
This pilot phase II trial studies how well a new reduced intensity conditioning regimen that includes haploidentical donor NK cells followed by the infusion of selectively T-cell depleted progenitor cell grafts work in treating younger patients with hematologic malignancies that have returned after or did not respond to treatment with a prior transplant. Giving chemotherapy and natural killer cells before a donor progenitor cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (progenitor cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy progenitor cells from a related donor are infused into the patient they make red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing specific T cells from the donor cells before the transplant may prevent this.
Conditions
Conditions (7)
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 (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myelogenous Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.80 |
| Juvenile Myelomonocytic Leukemia (JMML) | Juvenile Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloid Sarcoma | Myeloid Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma (NHL) | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD45RA-depleted HPC transplant | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Biological | — | UNRESOLVED |
| Interleukin-2 | Biological | Aldesleukin | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Natural killer cell therapy | Biological | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants
- description
- Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Biological: G-CSF
- Biological: Interleukin-2
- Drug: Melphalan
- Drug: Thiotepa
- Drug: Rituximab
- Biological: Natural killer cell therapy
- Biological: T-cell depleted HPC transplant
- Biological: CD45RA-depleted HPC transplant
Primary outcomes (1)
- measure
- Percentage of Participants Engrafted by Day 42 Post-transplant
- timeFrame
- Day 42 post transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age less than or equal to 21 years. * One of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic hematopoietic cell transplant (HCT): * ALL, AML, Myeloid Sarcoma, CML, Juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL) * Has a suitable single haplotype matched (≥ 3 of 6) family member donor. * Does not have any other active malignancy other than the one for which this transplant is indicated. * If prior central nervous system (CNS) leukemia, it must be treated and in CNS complete remission (CR) * Does not have current uncontrolled bacterial, fungal, or viral infection. * Patient must fulfill pre-transplant evaluation: * Left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25%. * Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2. * Forced vital capacity (FVC) ≥ 40% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing. * Karnofsky or Lansky (age-dependent) performance score ≥ 50 (See Appendix A). * Bilirubin ≤ 3 times the upper limit of normal for age. * Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age. * Not pregnant. If female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment. * Not breast feeding * DONOR: At least single haplotype matched (≥ 3 of 6) family member * DONOR: At least 18 years of age. * DONOR: HIV negative. * DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female). * DONOR: Not breast feeding. * DONOR: Regarding donation eligibility, is identified as either: * Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR * Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271.
References
Publications (0)
Data not yet available