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NCT00582816 · ClinicalTrials.gov registry record · Phase 1
Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00582816: Clinical Trial Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT00582816 is a Phase 1 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00582816, a Phase 1 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.
Primary Outcome
Skin Grade III: Stage 0-4 GVHD, where 0 is no rash and 4 is generalized erythroderma with bullous formation and/or with desquamation Grade IV: Stage 4 GVHD, generalized erythroderma with bullous formation and/or with desquamation GI (diarrhea) Grade III: Stage 2-4 GVHD, where 2 is \> 1000 mL/day but ≤ 1500 mL/day or 556-833 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena Grade IV: Stage 0-4 GVHD, where 0 is \< 500 mL/day or 280 mL/m2, and 4 is severe abdomina
Interventions
- DEVICE Clinimacs Cell Separation System
- DRUG conditioning chemotherapy
- OTHER DLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2008-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
Why NCT00582816 stopped before completion
NCT00582816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Clinimacs Cell Separation System is the first listed.
NCT00582816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00582816 about?
NCT00582816 is a clinical study titled "Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors". This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of adm...
What is the current status of trial NCT00582816?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2008-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00582816?
The interventions under investigation include: Clinimacs Cell Separation System (DEVICE), conditioning chemotherapy (DRUG), DLI (OTHER).
Who is sponsoring clinical trial NCT00582816?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00582816's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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