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NCT04395222 · ClinicalTrials.gov registry record · Phase 2
Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
A Phase 2 study of Hematologic Malignancy and Bone Marrow Transplant, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT04395222: Active Phase 2 study of Hematologic Malignancy and Bone Marrow Transplant, sponsored by Weill Medical College of Cornell University.
NCT04395222 is a Phase 2 study of Hematologic Malignancy and Bone Marrow Transplant that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 21 participants, below the 228-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04395222, a Phase 2 study of Hematologic Malignancy and Bone Marrow Transplant, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).
Primary Outcome
This is defined as: 1. Achieve an absolute neutrophil count (ANC) of 500 cells/microL for three consecutive days with the first on or prior to Day +21 post-transplant, AND 2. Absence of a second nadir - a drop in the ANC to \<300 cells/microL for five consecutive days - after initial neutrophil recovery.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Tocilizumab
- RADIATION Total Body Irradiation
- DRUG Anti-thymocyte globulin (rabbit)
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What the registry record for NCT04395222 still lists
NCT04395222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 228-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Hematologic Malignancy appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT04395222 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04395222 about?
NCT04395222 is a clinical study titled "Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation". The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse wh...
What is the current status of trial NCT04395222?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2020-10-07. Estimated completion is 2027-06.
What conditions does trial NCT04395222 study?
This clinical trial studies the following conditions: Hematologic Malignancy, Bone Marrow Transplant.
What interventions are being tested in trial NCT04395222?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Tocilizumab (DRUG), Total Body Irradiation (RADIATION), Anti-thymocyte globulin (rabbit) (DRUG).
Who is sponsoring clinical trial NCT04395222?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04395222 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04395222's enrollment target sits among peer trials
21 40th of 48 higher than 8 of 48 other Hematologic Malignancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancy 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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