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Cell Depletion
Cell Depletion Therapy for Blood Cancers
N/A
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial studies the impact of stem cells on hematologic malignancies, using a new system for cell depletion and individualized dosing of medicine to improve outcomes.
Who is the study for?
This trial is for patients under 25 with various blood cancers like leukemia and lymphoma, who are in remission or have minimal residual disease. They must be generally healthy, not pregnant, agree to use contraception, and can't be on other cancer treatments or part of another early-phase clinical study.Check my eligibility
What is being tested?
The study tests a cell sorting technique (CliniMACS) for young patients receiving stem cells from donors. It aims to remove certain immune cells to see if it helps with transplant success, reduces graft-versus-host disease (GVHD), and improves survival without the disease coming back.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system being weakened by cell depletion such as increased risk of infections. The ATG drug used may also cause allergic reactions, fever, chills, and low blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
Secondary outcome measures
Assess incidence of viral infections
Evaluate incidence of chronic GVHD
Evaluate incidence of relapse/progressive disease
+3 moreOther outcome measures
Assess ATG exposure using pre- and post- HCT AUC estimates using ATG dosing module
Assess tempo of CD4+ T cell reconstitution.
Assess tempo of immune reconstitution.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Alpha/Beta T cell depletion (TCD) plus CD19+ depletionExperimental Treatment1 Intervention
Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,673 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia shows no minimal residual disease.My donor's genetic markers have been closely matched to mine.My lymphoma is currently in remission after a relapse.I can care for myself but may not be able to do active work or play.My leukemia is in a very early stage and not detectable by most tests.I agree to use birth control during my treatment.My blood cancer is in remission, pending approval from the study leader.I am younger than 25 years old.My leukemia shows no minimal residual disease.My organs are functioning well enough for a bone marrow transplant.I have been diagnosed with myelodysplasia.I have no active cancer other than the one specified, or I've been cancer-free from another type for over a year.My condition does not match the specific disease, organ, or infection requirements.I am not on any cancer treatments not listed in the study.My donor and their collection center agree to the cell collection process.My donor is a family member who matches at least half of my HLA markers.My donor has passed all required health screenings for transplant.My lymphoblastic lymphoma is currently in remission.My Burkitt's lymphoma/leukemia is currently in remission.My donor matches me closely in at least 9 out of 10 genetic markers.I am over 18 and can consent, or my guardian has consented for me.My leukemia is in a chronic, accelerated phase, or second chronic phase after a blast crisis.I do not have any active, untreated infections and have been treated for any fungal infections.I am willing to undergo a procedure to donate stem cells for my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Alpha/Beta T cell depletion (TCD) plus CD19+ depletion
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.
Who qualifies to become a participant in this investigation?
"Candidates for this trial must have acute myeloid leukemia and be under the age of 25. The clinical study is currently seeking to enroll approximately 40 patients in total."
Answered by AI
What is the capacity of participants in this trial?
"Affirmative. Clinicaltrials.gov's data reveals that this trial has been actively recruiting since May 1st, 2023 and was last revised on June 9th of the same year. The research requires 40 volunteers at a single site to participate."
Answered by AI
Are there any current opportunities for participants in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research trial is presently searching for potential contributors. The original post date was on May 1st 2023 and the most recent modifications were made June 9th 2023. 40 participants are needed at one medical location."
Answered by AI
Does this clinical trial admit participants of advanced age?
"This experiment stipulates that the youngest patient should be 0 years old, while the oldest can not surpass 25."
Answered by AI
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