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NCT02130869 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02130869 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 8 participants.
The verdict
NCT02130869, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a haploidentical family member will be given after high dose chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma, the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic cell recovery will be evaluated and survival of children treated with this approach will be determined. The investigators expect to enroll 36 participants. Haploidentical family members (donors) will also be recruited to provide natural killer cells.
Interventions
- DRUG Melphalan
- DRUG Busulfan
- BIOLOGICAL hu14.18K322A
- BIOLOGICAL IL-2
- BIOLOGICAL CD133+ selected autologous stem cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-10-10 |
| Est. Completion | 2017-12-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02130869
The ClinicalTrials.gov registry entry for NCT02130869 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT02130869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02130869 about?
NCT02130869 is a clinical study titled "A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas". This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a ...
What is the current status of trial NCT02130869?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2014-10-10. Estimated completion is 2017-12-20.
What interventions are being tested in trial NCT02130869?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), hu14.18K322A (BIOLOGICAL), IL-2 (BIOLOGICAL), CD133+ selected autologous stem cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02130869?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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