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NCT04356469 · ClinicalTrials.gov registry record · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children
A Phase 2 study of Severe Aplastic Anemia and Bone Marrow Failure Syndrome, sponsored by Johns Hopkins All Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04356469 is a Phase 2 study of Severe Aplastic Anemia and Bone Marrow Failure Syndrome that is actively recruiting participants, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 17 participants, below the 126-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04356469, a Phase 2 study of Severe Aplastic Anemia and Bone Marrow Failure Syndrome, is actively recruiting participants, sponsored by Johns Hopkins All Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This research is being done to learn if a new type of haploidentical transplantation using TCR alpha beta and CD19 depleted stem cell graft from the donor is safe and effective to treat the patient's underlying condition. This study will use stem cells obtained via peripheral blood or bone marrow from parent or other half-matched family member donor. These will be processed through a special device called CliniMACS, which is considered investigational.
Conditions Studied
Interventions
- BIOLOGICAL Haploidentical Hematopoietic Cell Transplantation
Study Locations (1)
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04356469
The ClinicalTrials.gov registry entry for NCT04356469 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (87% lower). The listed sponsor is Johns Hopkins All Children's Hospital, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Severe Aplastic Anemia appearing as the primary indexed condition, and to 1 intervention - of which Haploidentical Hematopoietic Cell Transplantation is the first listed.
NCT04356469 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04356469 about?
NCT04356469 is a clinical study titled "TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children". This research is being done to learn if a new type of haploidentical transplantation using TCR alpha beta and CD19 depleted stem cell graft from the donor is safe and effective to treat the patient's underlying condition. This study will use stem cells obtained via peripheral blood or bone marrow fr...
What is the current status of trial NCT04356469?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-07-22. Estimated completion is 2026-06-30.
What conditions does trial NCT04356469 study?
This clinical trial studies the following conditions: Severe Aplastic Anemia, Bone Marrow Failure Syndrome, Hemoglobinopathy (Disorder).
What interventions are being tested in trial NCT04356469?
The interventions under investigation include: Haploidentical Hematopoietic Cell Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT04356469?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04356469 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Related
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