Comparing Stem Cell Transplant Options for Young People with Acute Leukemia or Myelodysplastic Syndrome

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05457556

Provider View

This study is exploring which type of stem cell transplant is better for children, teens, and young adults with acute leukemia or myelodysplastic syndrome: a transplant from a mismatched family member or a matched unrelated donor.

Patient Parameters

Program Overview

This clinical trial is comparing two types of stem cell transplants for young people with acute leukemia or myelodysplastic syndrome (MDS). The first type uses stem cells from a mismatched family member (haploidentical donor), and the second uses stem cells from a matched unrelated donor. Stem cell transplants are a standard treatment for these conditions, as they help restore healthy blood cell production after high-dose chemotherapy or radiation. This study aims to find out which donor type is more effective or if there is no difference between them.

Description

The main goal of this study is to compare the occurrence of severe Graft Versus Host Disease (GVHD) and disease-free survival in young patients receiving stem cell transplants from either a mismatched family member or a matched unrelated donor. Researchers will also look at overall survival rates, quality of life, and other health outcomes over time. Participants will be randomly assigned to receive one of the two types of transplants if they have both donor options available. If only a mismatched family member is available, they will receive that type of transplant. The study will involve regular health checks and follow-ups for up to five years after the transplant to monitor the patients' progress and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Aged 6 months to under 22 years.
  • Diagnosed with acute lymphoid leukemia (ALL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or mixed phenotype acute leukemia (MPAL).
  • Have not had a previous stem cell transplant.
  • Do not have a matched sibling donor.
  • Have a mismatched family member or a matched unrelated donor available.
  • Must provide informed consent to participate.
  • Meet all institutional and regulatory requirements for participation.
  • Can be enrolled in other related clinical trials.
  • Must meet specific health criteria before proceeding with the transplant, including adequate kidney, liver, heart, and lung function.

Exclusion Criteria

  • Have genetic disorders that affect bone marrow and are sensitive to certain treatments, such as Fanconi Anemia or Down syndrome.
  • Have any medical conditions that would make a high-dose stem cell transplant unsafe.
  • Are pregnant or breastfeeding.
  • Have active infections that are not controlled.
  • Have active cancer in the central nervous system or other areas outside the bone marrow at the time of transplant preparation.

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