20 Participants Needed

Cell-Depleted Donor Grafts for Blood Cancers

MT
Overseen ByMelinda Triplet, RN
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase I/II study designed to evaluate the kinetics of hematopoietic reconstitution and the incidence of acute chronic GVHD after partially matched related donor hematopoietic cell transplantation using an αβTCR/CD19+ cell depleted graft.

Are You a Good Fit for This Trial?

This trial is for children and young adults up to 30 years old with certain blood cancers or preleukemia conditions. They must have suitable organ function, may be eligible for a second transplant if needed, and cannot have active untreated infections. Participants need effective contraception if of childbearing potential and lack an HLA matched sibling donor.

Inclusion Criteria

I am using or willing to use effective birth control if I can have children.
I do not have a sibling donor that matches my HLA type.
My organ functions meet specific health standards.
See 6 more

Exclusion Criteria

I have specific antibodies against donor tissues.
Patient reports a history of allergic reactions to murine protein
I do not have a suitable donor available for my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo haploidentical hematopoietic cell transplantation using an αβTCR/CD19+ cell depleted graft

4-6 weeks
Multiple visits for transplantation and monitoring

Follow-up

Participants are monitored for safety, immune reconstitution, and incidence of GVHD

4 years
Regular follow-up visits over 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • CliniMACS® TCRαβ/CD19 Combined Depletion System
  • Partially Matched Related Donor Hematopoietic Cell Transplantation
  • αβTCR/CD19+ Cell Depleted Graft
Trial Overview The study tests the CliniMACS® TCRαβ/CD19 Depletion System in partially matched related donor hematopoietic cell transplantation. It aims to observe how quickly patients recover their blood cells and the occurrence of graft-versus-host disease after the procedure.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CliniMACS IsolationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
354
Recruited
5,228,000+
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