Study on Partially Matched Donor Stem Cell Transplant for Children with Blood Cancers and Myelodysplasia

Sponsor: Nationwide Children's Hospital

Sponsor score: 0

ClinicalTrials ID:NCT03431090

Provider View

This clinical trial is exploring a new method of stem cell transplant for children with blood cancers and myelodysplasia, using stem cells from a partially matched family member. The study aims to see how quickly and effectively the new cells grow and how often patients experience a condition called GVHD.

Patient Parameters

Program Overview

This study is testing a new approach to stem cell transplants for children with blood cancers and myelodysplasia. It uses stem cells from a family member who is a partial match, rather than a perfect match. The goal is to see if this method can help the new cells grow quickly and reduce the risk of a condition called GVHD, which can occur after a transplant.

Description

In many cases, children needing a stem cell transplant do not have a perfectly matched sibling donor. Finding an unrelated donor can take a long time and may not always be possible. This study is looking at using stem cells from a family member who is a partial match. The stem cells are specially prepared to remove certain types of cells that could cause problems. Researchers hope this method will help the new cells grow quickly and reduce the risk of GVHD, a condition where the new immune cells attack the patient's body. The study will monitor how well the new cells grow and how often GVHD occurs.

Eligibility Criteria

Inclusion Criteria

  • The child does not have a perfectly matched sibling donor.
  • The child must have good organ function as per specific medical guidelines.
  • If the child has had a previous transplant, they must be eligible for another if their disease has returned.
  • The child must undergo specific genetic testing.
  • The child cannot have an active untreated infection. Certain viral infections may require immediate treatment, and possible fungal infections must have been treated for at least two weeks.
  • Girls aged 11 and older must have a negative pregnancy test.
  • Sexually active participants must agree to use effective birth control.
  • Participants must be 30 years old or younger.
  • Consent must be signed by a parent or guardian for those under 18, and by the participant if they are 18 or older.

Exclusion Criteria

  • The child does not have a suitable donor who meets the necessary criteria.
  • The child has specific antibodies against the donor's cells.
  • The child has a history of allergic reactions to certain proteins.

Donor Eligibility:

  • The donor must be 18 years or older.
  • The donor must be a family member.
  • The donor must meet specific medical criteria.
  • The donor must be willing to undergo procedures to collect stem cells.

Locations

FACILITYZIPCITYSTATE
Nationwide Children's Hospital43205ColumbusOhio

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