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NCT05236764 · ClinicalTrials.gov registry record · NA

Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion

A NA study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by Baylor College of Medicine.

Active
Registry status
NA
Development phase
3
Enrollment target
2
Study locations

NCT05236764: Active NA study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by Baylor College of Medicine.

NCT05236764 is a NA study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 3 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05236764, a NA study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, is active but no longer recruiting, sponsored by Baylor College of Medicine.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
3 participants
Enrollment target
2
Study locations

Study Summary

Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematopoietic cell transplantation (HCT) with ex-vivo T cell receptor Alpha/Beta+ and CD19 depletion to treat patients' underlying condition. This process is expected to substantially decrease the risk of GvHD thus allowing for the elimination of immunosuppressive therapy post-transplant. The study will use blood stem/progenitor cells collected from the peripheral blood of parent or other half-matched (haploidentical) family member donor. The procedure will be performed using CliniMACS® TCRα/β-Biotin System which is considered investigational.

Primary Outcome

Cumulative incidence of neutrophil and platelet engraftment (composite measure) will be reported as rate and its associated 95% confidence interval. Competing risks methods will be utilized, with graft failure and death considered as competing risks. Neutrophil engraftment is defined as the first of 3 consecutive days with a peripheral blood absolute neutrophil count of ≥ 0.5x10\^9/L Platelet engraftment is defined as the first day with platelet count of ≥ 20 x10\^9/L without transfusion suppo

Conditions Studied

Myelodysplastic Syndromes Chronic Myeloid Leukemia Hemoglobinopathies Severe Aplastic Anemia Acute Myeloid Leukemia in Remission Cytopenia Acute Lymphoblastic Leukemia in Remission Bone Marrow Failure Syndrome Hemophagocytic Lymphohistiocytoses Primary Immunodeficiency Diseases

Interventions

  • DEVICE CliniMACS

Study Locations (2)

Texas

  • Houston Methodist Hospital - Houston
  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2023-12-06
Est. Completion 2026-05-23
Phase NA
Baylor College of Medicine

616 total trials

What the registry record for NCT05236764 still lists

NCT05236764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (99% lower).

The record links to 10 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which CliniMACS is the first listed.

NCT05236764 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT05236764 about?

NCT05236764 is a clinical study titled "Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion". Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematop...

What is the current status of trial NCT05236764?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 3 participants. The study started on 2023-12-06. Estimated completion is 2026-05-23.

What conditions does trial NCT05236764 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Hemoglobinopathies, Severe Aplastic Anemia, Acute Myeloid Leukemia in Remission.

What interventions are being tested in trial NCT05236764?

The interventions under investigation include: CliniMACS (DEVICE).

Who is sponsoring clinical trial NCT05236764?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05236764 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Myelodysplastic Syndromes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05236764's enrollment target sits among peer trials

3 172nd of 173 higher than 1 of 173 other Myelodysplastic Syndromes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05236764, the US trial registry maintained by the National Library of Medicine. NCT05236764 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.