Trial · NCT01464359
T-Cell Depleted Double UCB for Refractory AML
NCT01464359, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2015-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. T-Cell Depleted Double UCB for Refractory AML. Trials, record NCT01464359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01464359
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- T-Cell Depleted Double UCB for Refractory AML
- NCT number
- NCT01464359
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Acute Myelogenous Leukemia, Refractory Acute Myelogenous Leukemia
- Interventions
- Allopurinol, Fludarabine, Total body irradiation, Cyclophosphamide, Levetiracetam, Busulfan, Umbilical Cord Blood Transplantation, Interleukin-2
- First posted
- 2011-11-03
- Last updated
- 2017-12-28
- Results first posted
- 2015-05-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival | At 3 months | The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo. |
| Secondary | Incidence of Graft Failure | Day 42 | Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) |
| Secondary | Incidence of Acute Graft-Versus-Host Disease | Day 60 | |
| Secondary | Transplant-Related Mortality | Day 180 after Transplantation | |
| Secondary | Clinical Disease Response | 1 Year from Transplantation | Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care. |
| Secondary | Duration of Survival | 6 months after Transplantation. | |
| Secondary | Duration of Survival | 1 year after Transplantation. | |
| Secondary | Duration of Survival | 2 years after Transplantation. | |
| Secondary | Clinical Disease Response | 2 Years from Transplantation | Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival | At 3 months | participants | NUMBER | |
| SECONDARY | Incidence of Graft Failure | Day 42 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Acute Graft-Versus-Host Disease | Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Transplant-Related Mortality | Day 180 after Transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Disease Response | 1 Year from Transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Survival | 6 months after Transplantation. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Survival | 1 year after Transplantation. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Survival | 2 years after Transplantation. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Disease Response | 2 Years from Transplantation | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival | Patients With Acute Myelogenous Leukemia | 1 | participants | ||
| Incidence of Graft Failure | Patients With Acute Myelogenous Leukemia | 0 | Participants | ||
| Incidence of Acute Graft-Versus-Host Disease | Patients With Acute Myelogenous Leukemia | 0 | Participants | ||
| Transplant-Related Mortality | Patients With Acute Myelogenous Leukemia | 0 | Participants | ||
| Clinical Disease Response | Patients With Acute Myelogenous Leukemia | 2 | Participants | ||
| Duration of Survival | Patients With Acute Myelogenous Leukemia | 1 | Participants | ||
| Duration of Survival | Patients With Acute Myelogenous Leukemia | 0 | Participants | ||
| Duration of Survival | Patients With Acute Myelogenous Leukemia | 0 | Participants | ||
| Clinical Disease Response | Patients With Acute Myelogenous Leukemia | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With Acute Myelogenous Leukemia | 3 | |
| Overall Study | COMPLETED | Patients With Acute Myelogenous Leukemia | 3 | |
| Overall Study | NOT COMPLETED | Patients With Acute Myelogenous Leukemia | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | febrile neutropenia | Blood and lymphatic system disorders | Patients With Acute Myelogenous Leukemia | 3 | 3 | |
| other | chills | General disorders | Patients With Acute Myelogenous Leukemia | 3 | 3 | |
| other | injection site reaction | General disorders | Patients With Acute Myelogenous Leukemia | 2 | 3 | |
| other | cholecystitis | Hepatobiliary disorders | Patients With Acute Myelogenous Leukemia | 1 | 3 | |
| other | bruising | Injury, poisoning and procedural complications | Patients With Acute Myelogenous Leukemia | 1 | 3 | |
| other | Headache | Nervous system disorders | Patients With Acute Myelogenous Leukemia | 2 | 3 | |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Patients With Acute Myelogenous Leukemia | 2 | 3 | |
| other | pain of skin | Skin and subcutaneous tissue disorders | Patients With Acute Myelogenous Leukemia | 1 | 3 | |
| other | other, rash | Skin and subcutaneous tissue disorders | Patients With Acute Myelogenous Leukemia | 2 | 3 | |
| other | Hypertension | Vascular disorders | Patients With Acute Myelogenous Leukemia | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With Acute Myelogenous Leukemia | ||
| Total, other adverse events | Patients With Acute Myelogenous Leukemia | 3 | 3 |
| Total, serious adverse events | Patients With Acute Myelogenous Leukemia | 2 | 3 |
Source ClinicalTrials.gov
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/NCT01464359
GET https://conductscience.org/api/trials/v1/NCT01464359/registered