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Cell Therapy
Standardized T Cell Dose for Bone Marrow Transplant
N/A
Waitlist Available
Led By Ayman Saad, MD
Research Sponsored by Donna Salzman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram
Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether standardizing the number of immune cells in stem cell transplants from siblings can improve outcomes for patients.
Who is the study for?
This trial is for adults over 19 who need a bone marrow transplant and have a perfectly matched sibling donor. They should fit specific health criteria, like good heart, kidney, lung function, and overall strength (Karnofsky ≥ 70%). People with previous transplants, certain high-risk disease features or uncontrolled infections can't join.Check my eligibility
What is being tested?
The study tests if standardizing the dose of immune cells (CD3+ T cells) in stem cell transplants from siblings makes treatment outcomes more predictable and manageable. It aims to see if this approach benefits patients by reducing complications.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical transplant-related risks such as infection due to immune suppression, graft-versus-host disease where the new cells attack the body's tissues, and other organ-specific issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is normal or above normal.
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My kidney function, measured by creatinine clearance, is good.
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I am able to care for myself but may not be able to do active work.
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My liver function tests are within normal limits.
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I am 19 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of acute graft versus host disease (aGVHD) with the chosen fixed dose of CD3+ cells
Secondary outcome measures
Disease free survival
Immune reconstitution over time
Incidence, severity and organ involvement with chronic GVHD (cGVHD)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CD3+ T-cell depletionExperimental Treatment1 Intervention
CD3+ T-cell depletion
Find a Location
Who is running the clinical trial?
Donna SalzmanLead Sponsor
University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,338 Total Patients Enrolled
Miltenyi Biotec, Inc.Industry Sponsor
9 Previous Clinical Trials
254 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant before.My leukemia or lymphoma is not responding well to treatment.My organs are functioning well, tested within the last 28 days.My heart's pumping ability is normal or above normal.My kidney function, measured by creatinine clearance, is good.I have a sibling who is a perfect HLA match for me, not including an identical twin.I am able to care for myself but may not be able to do active work.I do not have any uncontrolled infections.My liver function tests are within normal limits.I am 19 years old or older.I am scheduled for a mild bone marrow transplant procedure.
Research Study Groups:
This trial has the following groups:- Group 1: CD3+ T-cell 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.
Is there still space available for individuals to join this clinical experiment?
"According to public records, this clinical trial is no longer open for recruitment. Although the initial posting was on October 1st 2014 and there has been recent updates as of March 30th 2022, it appears that candidates are not being accepted at present. However, 45 other trials currently have openings for participants."
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