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Cell Therapy

Cell-Depleted Donor Grafts for Blood Cancers

Phase 1 & 2
Waitlist Available
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient lacks an HLA matched sibling donor
Meets criteria nonhematopoietic organ function according to NCH BMT SOP09
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is studying how well a cell-depleted related donor graft works in treating patients with hematologic cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to immune system suppression such as increased infection risk, complications from graft-versus-host disease (where transplanted cells attack patient's body), or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a sibling donor that matches my HLA type.
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My organ functions meet specific health standards.
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If my disease returns after my first stem cell transplant, I can have a second one.
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I am a female over 11 or have had my first period and my pregnancy test is negative.
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I am 30 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure incidence of acute GVHD
Measure incidence of chronic GVHD
Measure rates of immune reconstitution
+2 more
Secondary outcome measures
Define nonhematopoietic regimen related toxicities
Measure disease free survival
Measure overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CliniMACS IsolationExperimental Treatment1 Intervention
The mobilized peripheral blood cell collection (apheresis product) will be processed using a Miltenyi CliniMACS device according to the manufacturing instructions. The processing will deplete the αβTCR+ cells and CD19+ cells from the apheresis product to formulate the graft.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,483 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia
2018. "Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03431090.
~2 spots leftby Dec 2024
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