Trial · NCT01823198
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
NCT01823198, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies. Trials, record NCT01823198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01823198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
- NCT number
- NCT01823198
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Erythroid Leukemia, Acute Megakaryoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia in Remission, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Blasts Under 20 Percent of Bone Marrow Nucleated Cells, Blasts Under 20 Percent of Peripheral Blood White Cells, Chronic Myelomonocytic Leukemia, High Risk Myelodysplastic Syndrome, Myelodysplastic Syndrome, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Therapy-Related Acute Myeloid Leukemia, Therapy-Related Myelodysplastic Syndrome
- Interventions
Aldesleukin, Allogeneic CD56-positive CD3-negative Natural Killer Cells, Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Fludarabine Phosphate, Laboratory Biomarker Analysis, Peripheral Blood Stem Cell Transplantation, Pharmacological Study
- First posted
- 2013-04-04
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Up to 42 days | Participants that experienced DLT related to the NK Cells post transplant at different dose levels. |
| Secondary | Overall Survival | Up to 2 years | Participants that survived between day of transplant and day of death on different dose levels. |
| Secondary | Number of Participants With Grade 3 Toxicities | Up to day 42 | Number of participants that had grade 3 toxicities up to day 42. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Up to 42 days | Twenty one donor participants were not included in outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 2 years | Twenty one donor participants were not included in outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 Toxicities | Up to day 42 | Twenty one donor participants were not included in outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 1_10^6 | Group A: NK cells from KIR mismatched haplo donors | 2 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 2_10^7 | Group A: NK cells from KIR mismatched haplo donors | 1 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 3_ 3x10^7 | Group A: NK cells from KIR mismatched haplo donors | 0 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 4_ 10^8 | Group A: NK cells from KIR mismatched haplo donors | 0 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase II: NK Cell Dose Level 3_3x10^7 | Group A: NK cells from KIR mismatched haplo donors | 0 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase II: NK Cell Dose Level 4_ 10^8 | Group A: NK cells from KIR mismatched haplo donors | 0 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 1_10^6 | Group B: NK cells from KIR mismatched cord blood donors | 2 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 2_10^7 | Group B: NK cells from KIR mismatched cord blood donors | 2 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 3_ 3x10^7 | Group B: NK cells from KIR mismatched cord blood donors | 2 | Participants | |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | Phase I: NK Cell Dose Level 4_ 10^8 | Group B: NK cells from KIR mismatched cord blood donors | 2 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: NK Cell Dose Level 1_10^6 | 6 | |
| Overall Study | STARTED | Phase I: NK Cell Dose Level 2_10^7 | 6 | |
| Overall Study | STARTED | Phase I: NK Cell Dose Level 3_ 3x10^7 | 4 | |
| Overall Study | STARTED | Phase I: NK Cell Dose Level 4_ 10^8 | 4 | |
| Overall Study | STARTED | Phase II: NK Cell Dose Level 3_3x10^7 | 1 | |
| Overall Study | STARTED | Phase II: NK Cell Dose Level 4_ 10^8 | 21 | |
| Overall Study | STARTED | Donors | 21 | |
| Overall Study | COMPLETED | Phase I: NK Cell Dose Level 1_10^6 | 6 | |
| Overall Study | COMPLETED | Phase I: NK Cell Dose Level 2_10^7 | 5 | |
| Overall Study | COMPLETED | Phase I: NK Cell Dose Level 3_ 3x10^7 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events301
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABO incompatibility | Investigations | Phase I: NK Cell Dose Level 1_10^6 | 0 | 6 | |
| other | ABO incompatibility | Investigations | Phase I: NK Cell Dose Level 2_10^7 | 1 | 6 | |
| other | ABO incompatibility | Investigations | Phase I: NK Cell Dose Level 3_ 3x10^7 | 0 | 4 | |
| other | ABO incompatibility | Investigations | Phase I: NK Cell Dose Level 4_ 10^8 | 1 | 4 | |
| other | ABO incompatibility | Investigations | Phase II: NK Cell Dose Level 3_3x10^7 | 0 | 1 | |
| other | ABO incompatibility | Investigations | Phase II: NK Cell Dose Level 4_ 10^8 | 0 | 21 | |
| other | ABO incompatibility | Investigations | Donors | 0 | 0 | |
| other | Allergic reaction | Immune system disorders | Phase I: NK Cell Dose Level 1_10^6 | 0 | 6 | |
| other | Allergic reaction | Immune system disorders | Phase I: NK Cell Dose Level 2_10^7 | 1 | 6 | |
| other | Allergic reaction | Immune system disorders | Phase I: NK Cell Dose Level 3_ 3x10^7 | 0 | 4 |
1 to 10 of 301Source ClinicalTrials.gov
See all 301 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: NK Cell Dose Level 1_10^6 | 1 | 6 |
| Total, all-cause mortality | Phase I: NK Cell Dose Level 2_10^7 | 4 | 6 |
| Total, all-cause mortality | Phase I: NK Cell Dose Level 3_ 3x10^7 | 2 | 4 |
| Total, all-cause mortality | Phase I: NK Cell Dose Level 4_ 10^8 | 1 | 4 |
| Total, all-cause mortality | Phase II: NK Cell Dose Level 3_3x10^7 | 0 | 1 |
| Total, all-cause mortality | Phase II: NK Cell Dose Level 4_ 10^8 | 9 | 21 |
| Total, all-cause mortality | Donors | 0 | 0 |
| Total, other adverse events | Phase I: NK Cell Dose Level 1_10^6 | 6 | 6 |
| Total, other adverse events | Phase I: NK Cell Dose Level 2_10^7 | 5 | 6 |
| Total, other adverse events | Phase I: NK Cell Dose Level 3_ 3x10^7 | 4 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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/NCT01823198
GET https://conductscience.org/api/trials/v1/NCT01823198/results?page=2