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T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias

NCT03653338 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-08-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate what effect, if any, mismatched unrelated volunteer donor and/or haploidentical related donor stem cell transplant may have on severe sickle cell disease and other transfusion dependent anemias. By using mismatched unrelated volunteer donor and/or haploidentical related donor stem cells, this study will increase the number of patients who can undergo a stem cell transplant for their specified disease. Additionally, using a T-cell depleted approach should reduce the incidence of graft-versus-host disease which would otherwise be increased in a mismatched transplant setting.

Conditions

Interventions

BIOLOGICAL

CD3/CD19 depleted leukocytes

Negative selection for CD3+/CD19+ cells will be performed on the CliniMACS® depletion device.

BIOLOGICAL

CD45RA depleted leukocytes

Negative selection for CD45RA will be performed on the CliniMACS® depletion device.

DRUG

Hydroxyurea

Sickle Cell Disease Conditioning

DRUG

Rituximab

Sickle Cell Disease Conditioning

DRUG

Alemtuzumab

Sickle Cell Disease Conditioning

DRUG

Fludarabine

Sickle Cell Disease Conditioning

DRUG

Thiotepa

Sickle Cell Disease Conditioning

Sponsors & Collaborators

  • Paul Szabolcs

    lead OTHER

Principal Investigators

  • Paul Szabolcs, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2026-08-01
Completion
2027-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653338 on ClinicalTrials.gov