Clinical trial · Interventional
A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES
NCT00569179CI-TRIAL-00018988terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphoid | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia, Myelogenous, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS CD34 Reagent System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alloreactive NK cell infusion
- description
- Escalating doses of alloreactive NK cells.
- interventionNames
- Device: CliniMACS CD34 Reagent System
Primary outcomes (1)
- measure
- Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.
- timeFrame
- through Day 128
Secondary outcomes (5)
- measure
- Assess toxicity associated with the infusion of alloreactive NK cells
- timeFrame
- through Day 128
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically documented AML, ALL, MDS, CML, * Identification of haploidentical donor * LVEF \> 45% corrected * DLCO \> 50% predicted * Serum Creatinine \<= 2 mg/dL * Bilirubin \< 2 x ULN * AST, ALT \< 2 x ULN * Age ≤ 65 years * Performance Status 0-1 Exclusion Criteria: * Patients relapsing \<6 months after autologous SCT are not eligible. * Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection * No HIV disease * Non-pregnant and non-nursing
References
Publications (0)
Data not yet available
No reference posted for this study.