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NCT05384756 · ClinicalTrials.gov registry record · Phase 1
TMLI and Alemtuzumab for Treatment of Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT05384756: Active Phase 1 study of Sickle Cell Disease, sponsored by City of Hope Medical Center.
NCT05384756 is a Phase 1 study of Sickle Cell Disease that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 2 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05384756, a Phase 1 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease. Conditioning regimens are treatments used to prepare a patient for stem cell transplantation. A stem cell transplant is a procedure in which a person receives blood stem cells, which make any type of blood cell. A conditioning regimen may include chemotherapy, monoclonal antibody therapy, and radiation to the entire body. It helps make room in the patient's bone marrow for new blood stem cells to grow, and helps prevent the patient's body from rejecting the transplanted cells. Alemtuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Graft-versus-host disease (GVHD) is a complication that may occur after hematopoietic cell transplantation (HCT) in which donated cells view the recipient's cells as foreign and attack them. Giving TMLI and alemtuzumab may help reduce organ damage that can be caused by radiation and decrease the risk of GVHD.
Primary Outcome
Will be scored on the Bearman Scale National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with the unacceptable adverse events will be calculated along with the appropriate Clopper-Pearson 90% confidence intervals.
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Alemtuzumab
- RADIATION Intensity-Modulated Radiation Therapy
- PROCEDURE Hematopoietic Cell Transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
What the registry record for NCT05384756 still lists
NCT05384756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.
NCT05384756 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05384756 about?
NCT05384756 is a clinical study titled "TMLI and Alemtuzumab for Treatment of Sickle Cell Disease". This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease. Conditioning regimens are treatments used to prepare a patient for stem cell transplantation. A stem cell transplant i...
What is the current status of trial NCT05384756?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-07-13. Estimated completion is 2026-12-01.
What conditions does trial NCT05384756 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT05384756?
The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Hematopoietic Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT05384756?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05384756 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05384756's enrollment target sits among peer trials
2 213th of 213 the lowest of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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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