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NCT01287104 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01287104: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01287104 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287104, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: * Bone marrow stem cells, which are found in the bone marrow and blood stream, can be collected and transplanted to treat a variety of types of cancer in a process known as hematopoietic stem cell transplantation (HSCT). When stem cells are taken from one person, most commonly a sibling or a family member, and then given to another person, this is referred to as allogeneic HSCT. Allogeneic HSCT has proven to be an especially effective treatment for patients with some types of cancers of the blood (leukemia) and certain solid tumors. The transplanted stem cells travel to the patient's bone marrow and begin producing normal blood cells, and also attack patients cancer cells. * Because allogenic HSCT does not always prevent the cancer from returning, researchers are interested in determining whether another type of immune cell taken from the stem cell donors white blood cells, called a "natural killer" (NK) cell, can be given in addition to the HSCT to help fight the tumor. In the laboratory, NK cells have been shown to kill tumor cells, but it is not yet know if this will occur when given to patients after HSCT. Objectives: * To determine the safety, effectiveness, and immune system response of giving NK white blood cells to individuals who have received allogeneic HSCT. * To identify possible side effects from the treatment. Eligibility: * Donors: Stem cell donors whose blood matches one of the recipients on six out of six human leukocyte antigen (HLA) (blood immune marker) types. The donor may not be the identical twin of a recipient. * Recipients: Individuals between 4 and 35 years of age who have been diagnosed with pediatric solid tumors that have not responded to standard treatment, or individuals between 4 and 18 years of age who have been diagnosed with leukemia that has not responded to standard treatment. * Other eligibility requirements which include a physical exam and blood laboratory evaluation are included to make sure it is safe for bo
Primary Outcome
Participants received 2 doses of natural killer infusions within 56 days of hematopoietic stem cell transplant (HSCT).
Interventions
- BIOLOGICAL Natural Killer (NK) Cell Infusion
- BIOLOGICAL Stem Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-01-29 |
| Est. Completion | 2018-06-28 |
| Phase | Phase 1 |
What the finished NCT01287104 record still lists
NCT01287104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Natural Killer (NK) Cell Infusion is the first listed.
NCT01287104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01287104 about?
NCT01287104 is a clinical study titled "A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias". Background: * Bone marrow stem cells, which are found in the bone marrow and blood stream, can be collected and transplanted to treat a variety of types of cancer in a process known as hematopoietic stem cell transplantation (HSCT). When stem cells are taken from one person, most commonly a sibling...
What is the current status of trial NCT01287104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-01-29. Estimated completion is 2018-06-28.
What interventions are being tested in trial NCT01287104?
The interventions under investigation include: Natural Killer (NK) Cell Infusion (BIOLOGICAL), Stem Cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT01287104?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01287104's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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