Study Summary
This trial is testing the safety and effectiveness of a new conditioning regimen for stem cell transplantation in patients with sickle cell disease. The conditioning regimen includes total marrow and lymphoid irradiation (TMLI) and alemtuzumab. Alemtuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The goal of this trial is to reduce organ damage that can be caused by radiation and decrease the risk of graft-versus-host disease (GVHD).
- Sickle Cell Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: Up to 2 years
Trial Safety
Safety Progress
Side Effects for
Trial Design
1 Treatment Group
Treatment (TMLI, alemtuzumab)
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Hematopoietic Cell Transplantation · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 12 - 40 · All Participants · 39 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is this experiment enlisting participants aged twenty or above?
"In order to be eligable for this medical trial, applicants must between 12 and 40 years old. There are 131 trials available exclusively to those under 18 while 86 of the studies are accessible only by individuals above 65 years of age." - Anonymous Online Contributor
Can I take part in this experimental procedure?
"This clinical trial seeks twenty individuals aged between 12 and 40 who currently suffer from anemia due to sickle cell. In addition, patients must be willing to assent as per institutional guidelines; registered into the REMS program; possess an ECOG performance status lower than or equal to 2; have experienced a stroke or neurological deficit lasting longer than 24 hours with increased transcranial Doppler velocity greater than 200 m/s; suffered recurrent priapism necessitating medical intervention; provided informed consent of their own volition or by legal representative if applicable; experienced one more episodes of acute chest syndrome in the past two years despite supportive care measures" - Anonymous Online Contributor
Has the FDA sanctioned Hematopoietic Cell Transplantation?
"Our team has rated the safety of Hematopoietic Cell Transplantation a 1 as this is currently in its Phase 1 trial, which suggests that there are only limited data to support its efficacy and safety." - Anonymous Online Contributor
Does this clinical experiment still have the capacity to enroll new participants?
"Affirmative. The clinical trial registry contains evidence that this particular experiment has been recruiting since July 13th 2022, with the most recent update on July 31st 2022. Around 20 patients are being sought from a single medical facility." - Anonymous Online Contributor
What outcomes is this clinical trial aiming to achieve?
"This trial will have two-year follow up and the primary outcome being monitored is incidence of adverse events. Secondary endpoints include cumulative incidence of chronic GVHD, aGVHD within 100 days post-transplant, and platelet engraftment (defined as independence from transfusions with more than 20x10^9/L)." - Anonymous Online Contributor
How many participants are sought for this research program?
"Affirmative. The information on clinicaltrials.gov indicates that this medical trial is in a state of active enrollment, having been initially posted on July 13th 2022 and updated most recently on the 31st of July. They are hoping to acquire 20 participants from one site." - Anonymous Online Contributor