Trial · NCT02130869
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
NCT02130869, Phase 1, Completed, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT02130869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02130869
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02130869
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Neuroblastoma, Lymphoma, High-risk Tumor
- Interventions
CD133+ selected autologous stem cell infusion, IL-2, hu14.18K322A, Busulfan, Melphalan, GM-CSF, Bendamustine, Etoposide, Cytarabine, Carboplatin, Haploidentical natural killer cell infusion, G-CSF, Etoposide phosphate, CliniMACS
- First posted
- 2014-05-06
- Last updated
- 2017-12-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of participants with positive ANC engraftment | Day 35 post transplant | Feasibility will be determined based on ANC engraftment defined as ANC ≥500/mm\^3 for 3 consecutive tests performed on different days evaluated before day 35 post-transplant. If the study is considered feasible, the ANC engraftment rate will be 100% (95% Blyth-Still-Casella (BSC) CI: 76.45%-100%) without any failure, 92% (BSC 95% CI: 65.11%-99.57%) with 1 failure, and 83% (BSC 95% CI: 55%-96.95%) with 2 failures. In addition, if more than 2 (≥ 3) on-therapy patients die due to any protocol treatment-related causes during the first 12 months post-transplant across all groups (3 deaths among 36 participants), the study will be stopped. Deaths due to treatment not specified in this protocol will not be included in evaluation of this stopping rule. |
| Secondary | Overall survival | Up to one year after transplantation | Overall survival is defined based on any death. The Kaplan-Meier Estimate will be provided. |
| Secondary | Disease-free survival | Up to one year after transplantation | Disease-free survival is defined based on any death, graft failure, or relapsed/resistant disease. The Kaplan-Meier Estimate will be provided. |
| Secondary | Incidence of relapse | Up to one year after transplantation | Cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. |
| Secondary | Lymphocyte and hematopoietic reconstitution | Up to one year after transplantation | The hematopoietic cell recovery and engraftment rates will be reported with a Blyth-Still-Casella 95% confidence interval. |
| Secondary | Characteristics of the stem cell grafts | Up to one year after transplantation | Results will be reported and presented descriptively. |
| Secondary | Characteristics of the natural killer cell grafts. | Up to one year after transplantation | Results will be reported and presented descriptively. |
| Secondary | Overall survival of patients treated without stem cell manipulation or NK cell infusion due to off therapy criteria | Up to one year after transplantation | The Kaplan-Meier estimate will be provided for overall survival analysis. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02130869
GET https://conductscience.org/api/trials/v1/NCT02130869/registered