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New treatment option for Sickle Cell Disease
Official title Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
ClinicalTrials.gov ID: NCT03121001
What this study is testing
What is ATG?
ATG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease.
Also referred to as Thymoglobulin®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a Phase II clinical trial. Patients will receive intensity modulated total body irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 60
You may be able to join if
- Patient Eligibility:
- Patients with sickle cell disease are eligible if they have any of the following complications: 1.1 Stroke or central nervous system event lasting...
- Age 16-60 years
- Karnofsky performance status of 60 or higher (Appendix A)
- Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40%
See the full eligibility criteria
- Patient Eligibility:
- Patients with sickle cell disease are eligible if they have any of the following complications: 1.1 Stroke or central nervous system event lasting longer than 24 hours 1.2 Frequent vaso-occlusive pain episodes, defined...
- Age 16-60 years
- Karnofsky performance status of 60 or higher (Appendix A)
- Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40%
- Adequate pulmonary function, defined as diffusion lung capacity of carbon monoxide ≥ 50% predicted (after adjustment for hemoglobin concentration)
- Estimated GFR ≥ 50mL/min/1.73m2 as calculated by the modified MDRD equation
- ALT ≤ 3x upper limit of normal
- HIV-negative
- Patient is not pregnant
- Patient is able and willing to sign informed consent
- Patient does not have a fully HLA-matched sibling donor
- Patient has an HLA-haploidentical relative Donor Eligibility Relatives (parents, offspring, siblings, aunts/uncles, cousins) will be tested by molecular typing of HLA class I (A, B, and C) and class II (DRB1) at low...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.