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NCT01810588 · ClinicalTrials.gov registry record · Phase 2
Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
A Phase 2 study of Hematologic Malignancies, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
- 2
- Study locations
NCT01810588: Active Phase 2 study of Hematologic Malignancies, sponsored by Weill Medical College of Cornell University.
NCT01810588 is a Phase 2 study of Hematologic Malignancies that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 270 participants, below the 2,706-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01810588, a Phase 2 study of Hematologic Malignancies, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
- 2
- Study locations
Study Summary
In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant is a novel and promising way to improve transplant outcomes. We hypothesize that identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA) targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective recipient) is more important to the outcome of haplo cord transplant than the nucleated cell dose. The identification of such a graft for a large proportion of the subjects may necessitate accepting a lower umbilical cord graft dose. In addition to a umbilical cord blood transplant, recipients will receive stem cells from a family member ( a haplo-identical donor) . After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device. The subject will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Rituximab
- DEVICE CliniMACS® CD34 Reagent System
- DRUG anti-thymocyte globulin (rabbit)
Study Locations (2)
Illinois
- University of Chicago Medical Center - Chicago
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2012-10-16 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What the registry record for NCT01810588 still lists
NCT01810588 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 2,706-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT01810588 reports a single indexed study location in Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT01810588 about?
NCT01810588 is a clinical study titled "Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation". In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant is a novel and promising way to improve transplant outcomes. We hypothesize that identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA) targeted (i.e., cord blood grafts...
What is the current status of trial NCT01810588?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2012-10-16. Estimated completion is 2028-04.
What conditions does trial NCT01810588 study?
This clinical trial studies the following conditions: Hematologic Malignancies.
What interventions are being tested in trial NCT01810588?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Rituximab (DRUG), CliniMACS® CD34 Reagent System (DEVICE), anti-thymocyte globulin (rabbit) (DRUG).
Who is sponsoring clinical trial NCT01810588?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01810588 being conducted?
This trial has 2 study locations across Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01810588's enrollment target sits among peer trials
270 7th of 45 higher than 39 of 45 other Hematologic Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancies 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.
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