Standardized T Cell Dose for Bone Marrow Transplant

Recruiting in Palo Alto (17 mi)

Overseen byAyman Saad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Donna Salzman

No Placebo Group

Trial Summary

What is the purpose of this trial?Stem cells collected from sibling donors for allogenic transplants contain various types of cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose will benefit the recipient (patient). As well as to help discover if dose standardization causes less variation in outcomes between patients and to make transplantation more predictable and complications easier to manage.

Eligibility Criteria

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.

Inclusion Criteria

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.

+6 more

Exclusion Criteria

I have had a stem cell transplant before.

My leukemia or lymphoma is not responding well to treatment.

I do not have any uncontrolled infections.

+2 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: CD3+ T-cell depletionExperimental Treatment1 Intervention

CD3+ T-cell depletion