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Allogeneic Stem Cell Transplant for High-Risk Hemoglobinopathies

This study is for people up to 55 years old with high-risk hemoglobinopathies (blood disorders like sickle cell disease or thalassemia) who need a stem cell transplant from a donor. It's testing a specific transplant regimen that includes several medications: Alemtuzumab, Total Body Irradiation (a type of radiation therapy), and Thymoglobulin, along with Fludarabine. These treatments are given before receiving healthy stem cells from a donor. The main goal is to see how often Graft versus Host Disease (GvHD), a complication where the donor cells attack your body, occurs within one year after the transplant. The study is open to people with Sickle Cell Disease who have a fully matched sibling donor, as well as those with transfusion-dependent Alpha- or Beta-Thalassemia, Diamond Blackfan Anemia, and other similar conditions. We are looking to enroll about 62 participants.

Study design
This is a single-center, open-label, interventional Phase II study. It is testing a specific treatment approach for about 62 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year to monitor for Graft versus Host Disease (GvHD).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06872333

Allo HSCT for High Risk Hemoglobinopathies

Recruiting
PHASE2Up to 55Interventional
Masonic Cancer Center, University of Minnesota
~62 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:AlemtuzumabTotal Body IrradiationCell InfusionThymoglobulinFludarabineBusulfan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Graft versus Host Disease (GvHD)
Measured over 1 year

Conditions

Graft Failure
Sickle Cell Disease
Hemoglobinopathies

Explore related trials

Alpha ThalassemiaBeta ThalassemiaDiamond-Blackfan AnemiaHemoglobinopathyOther Non-Malignant Hematologic DisordersSickle Cell Disease

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Ashish Gupta, MBBS, MPH
[email protected]
612-626-2961
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Sickle Cell Disease (SCD)
SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents/patient must be counseled as to the risks and benefits and provide their voluntary informed consent
Transfusion Dependent Alpha- or Beta- Thalassemia
Diamond Blackfan Anemia
Other Non-Malignant Hematologic Disorders
Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.
Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.

Exclusion

Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 30 days of the start of treatment
HIV infection with a detectable viral load. All HIV+ patients must be evaluated by infectious disease (ID) and an HIV management plan established prior to transplantation.
Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
Known allergy to any of the study components
Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study

What this trial measures

  • Incidence of Graft versus Host Disease (GvHD)1 year