Abatacept for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byLeland Metheny, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Leland Metheny

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT. Participants will: * Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.

Eligibility Criteria

This trial is for individuals with certain blood cancers like leukemia, lymphoma, and myelodysplastic syndrome. It's also open to those with specific genetic conditions such as Klinefelter or Triple X Syndrome. Participants must be suitable for a cord blood transplant and able to undergo pre-transplant conditioning treatments including radiation.

Inclusion Criteria

I am between 18 and 65 years old.

I can carry out normal activities with minimal symptoms.

Patients with specific cord blood unit requirements

+4 more

Exclusion Criteria

Patients with uncontrolled inter-current illness

Any condition that would interfere with full participation in the study

Hematopoietic Cell Transplantation Comorbidity index greater than 5

+5 more

Participant Groups

The study tests if adding abatacept to the standard graft versus host disease prevention (which includes tacrolimus and MMF) can reduce complications after a double umbilical cord transplant in blood cancer patients. The safety and effectiveness of abatacept in this context are being evaluated.

1Treatment groups

Experimental Treatment

Group I: Cy/Flu/Thio/TBI + dCBT + Tac/MMF + AbataceptExperimental Treatment8 Interventions

Cyclophosphamide (Cy), fludarabine (Flu), thiotepa (Thio), and total body irradiation (TBI) is the preparative regimen for Double Umbilical Cord Transplant (dCBT). Graft-versus-host disease prophylaxis will consist of tacrolimus (Tac) and mycophenolate mofetil (MMF). Abatacept will be administered.