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T-Cell Depletion
CliniMACS® T-Cell Depletion for Stem Cell Transplant Patients
N/A
Recruiting
Led By Christopher C Dvorak, MD
Research Sponsored by Christopher Dvorak
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documentation of a disease requiring HCT
Male or female 0-30 years of age at time of transplant admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether or not the CliniMACS® Device can be used to deplete T cells from donor cells for patients who need an allogeneic HCT.
Who is the study for?
This trial is for males and females aged 0-30 needing a stem cell transplant due to certain diseases, with donors available who can give bone marrow or blood stem cells. It's not for those with identical related donors (unless they have Fanconi Anemia), life expectancy under one month, mouse protein or iron dextran allergies, pregnant/breastfeeding individuals, or if birth control isn't used.Check my eligibility
What is being tested?
The study tests the CliniMACS® Device's ability to remove specific T-cells from donor cells before transplant to prevent graft-versus-host disease. This process is being evaluated as it's currently only FDA-approved for limited use and needs further investigation in other settings.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to immune system suppression such as increased infection risk and complications associated with the transplantation procedure itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition requires a stem cell transplant.
Select...
I am 30 years old or younger and am going for a transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
100-day incidence of Grade III-IV acute GVHD
Secondary outcome measures
1-year incidence of autoimmunity requiring intervention with immunosuppressive agents as treatment.
1-year incidence of systemic steroid-requiring chronic GVHD
1-year incidence of transplant-related mortality
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Patients receiving allogeneic hematopoietic cell transplantExperimental Treatment1 Intervention
The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml/kg/hour).
The target dose of CD34+ cells is ≥20x10^6/kg, but a minimum of
≥2.5x10^6/kg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10^5/kg.
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Who is running the clinical trial?
Christopher DvorakLead Sponsor
1 Previous Clinical Trials
Christopher C Dvorak, MDPrincipal InvestigatorProfessor of Clinical Pediatrics
1 Previous Clinical Trials
16 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a healthy donor ready to give bone marrow or stem cells.My condition requires a stem cell transplant.I have a healthy, willing, and HLA-matched relative to donate (unless I have Fanconi Anemia).I am 30 years old or younger and am going for a transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Patients receiving allogeneic hematopoietic cell transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to volunteer for this clinical trial?
"As evidenced by clinicaltrials.gov, this research project is still searching for participants to include in the study. The trial was first posted on December 19th 2019 and its details were last revised on August 2nd 2022."
Answered by AI
What is the scale of recruitment for this medical experiment?
"Affirmative. The information on clinicaltrials.gov attests that enrollment for this investigation, which was first announced on December 19th 2019, is still ongoing. 90 individuals are being sought from a single centre to partake in the trial."
Answered by AI
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