Trial · NCT01810588
Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
NCT01810588, Phase 2, Completed, Weill Medical College of Cornell University; results first posted 2024-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation. Trials, record NCT01810588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01810588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
- NCT number
- NCT01810588
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 270 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Hematologic Malignancies
- Interventions
- CliniMACS® CD34 Reagent System, Fludarabine, Melphalan, anti-thymocyte globulin (rabbit), Rituximab, Total Body Irradiation, Mycophenolate Mofetil, Tacrolimus
- First posted
- 2013-03-13
- Last updated
- 2026-08-19
- Results first posted
- 2024-10-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose | 100 days | We aim to identify the lowest threshold of umbilical cord total nucleated cell (TNC) dose that can be utilized assure durable umbilical cord blood engraftment in the haplo-cord transplants. The threshold will be defined as the lowest dose which assures cord blood engraftment occurs in at least 80% of subjects. |
| Secondary | Long-term Survival of Subjects Undergoing Haplo-cord Transplants | 5 years after transplant | Evaluate the long term outcome of subjects undergoing haplo cord transplants using an optimally matched umbilical cord blood (UCB) graft (i.e. Survival, profession-free survival (PFS), Relapse, transplant-related mortality (TRM), toxicities, infections and GVHD) |
| Secondary | Impact of IPA Targeting on Transplant Outcome | 5 years from transplantation | As much as possible, UCB units will be chosen to be IPA targeted. This is not always possible. We will therefore also retrospectively analyze transplant outcomes and correlate with IPA status. |
| Secondary | Impact of NIMA Matching on Transplant Outcome | 5 years from transplantation | As much as possible, UCB units will be chosen to be NIMA matched. This is not always possible. We will therefore also retrospectively analyze transplant outcomes and correlate with NIMA status. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose | 100 days | A subset of participants were assessed to analyze the lowest threshold of umbilical cord total nucleated cell (TNC) dose. Once the lowest threshold was established, the remaining participants on study were treated based on that threshold. | participants | NUMBER |
| SECONDARY | Long-term Survival of Subjects Undergoing Haplo-cord Transplants | 5 years after transplant | |||
| SECONDARY | Impact of IPA Targeting on Transplant Outcome | 5 years from transplantation | |||
| SECONDARY | Impact of NIMA Matching on Transplant Outcome | 5 years from transplantation |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose | All Patients | Participants Achieving Engraftment with Minimum TNC of 2 x 10^5/kg | 15 | participants | |
| Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose | All Patients | Participants Achieving Engraftment with Minimum TNC of 1 x 10^5/kg in umbilical cord blood unit | 18 | participants | |
| Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose | All Patients | Participants Achieving Engraftment with Minimum TNC of 0.5 x 10^5/kg | 20 | participants |
Source ClinicalTrials.gov
Participant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | STARTED | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 15 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | STARTED | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | STARTED | Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | STARTED | Cohort 4 | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | COMPLETED | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 15 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | COMPLETED | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | COMPLETED | Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | COMPLETED | Cohort 4 | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | NOT COMPLETED | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 0 | |
| Cohort 1 - Minimum Cell Dose 2 x 10^7 TN | NOT COMPLETED | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events472
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 | Cytomegalovirus viremia | Infections and infestations | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 2 | 15 | 2 |
| other | Cytomegalovirus viremia | Infections and infestations | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 2 | 20 | 2 |
| other | Cytomegalovirus viremia | Infections and infestations | Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg | 4 | 25 | 4 |
| other | Cytomegalovirus viremia | Infections and infestations | Cohort 4 | 30 | 210 | 31 |
| other | Bacteremia | Infections and infestations | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 0 | 15 | 0 |
| other | Bacteremia | Infections and infestations | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 1 | 20 | 1 |
| other | Bacteremia | Infections and infestations | Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg | 0 | 25 | 0 |
| other | Bacteremia | Infections and infestations | Cohort 4 | 1 | 210 | 1 |
| other | C. difficile colitis | Infections and infestations | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 0 | 15 | 0 |
| other | C. difficile colitis | Infections and infestations | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 3 | 20 | 3 |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 6 | 15 |
| Total, all-cause mortality | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 6 | 20 |
| Total, all-cause mortality | Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg | 11 | 25 |
| Total, all-cause mortality | Cohort 4 | 79 | 210 |
| Total, other adverse events | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 6 | 15 |
| Total, other adverse events | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 6 | 20 |
| Total, other adverse events | Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg | 12 | 25 |
| Total, other adverse events | Cohort 4 | 93 | 210 |
| Total, serious adverse events | Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg | 7 | 15 |
| Total, serious adverse events | Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg | 9 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01810588
GET https://conductscience.org/api/trials/v1/NCT01810588/flow?page=2