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Cell Therapy

Haploidentical Transplant for Leukemia

Phase 2

Waitlist Available

Research Sponsored by Michael Pulsipher, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age < 22 years

Karnofsky Index or Lansky Play-Performance Scale ≥ 60 % on pre-transplant evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial studies transplants from half-matched donors to treat leukemia, AML and MDS in children. It will also examine how a genetic factor affects survival.

Who is the study for?

This trial is for children under 22 with high-risk acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS) who are undergoing a bone marrow transplant. It's open to those eligible for HCT at participating centers and includes patients with specific genetic features or disease statuses outlined in the criteria.Check my eligibility

What is being tested?

The study tests haploidentical transplantation using donors with favorable KIR genes in kids with ALL, AML, or MDS. It also examines how variations in the KIR2DL1 gene affect survival post-transplantation. The intervention involves a CliniMacs TCR alpha-beta-Biotin system for T-cell depletion.See study design

What are the potential side effects?

While not explicitly listed, side effects may include typical risks associated with bone marrow transplants such as infection risk due to immune suppression, graft-versus-host disease where donor cells attack the patient's body, and complications from T-cell depletion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am younger than 22 years old.

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I am mostly independent and can do some daily activities.

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I have not had a stem cell transplant from another person.

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My condition is either high-risk ALL in first or second remission, MDS, or high-risk AML.

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I have a family member who can donate stem cells that match mine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

1 yr disease free survival of patients transplanted with donors homozygous for KIR2DL1-C245 will be compared to patients with donors hetero- or homozygous for KIRD2DL1-R245 polymorphisms

Disease free survival at 1 year post HCT

Secondary outcome measures

T-Cell Receptor

1- and 2-year overall survival (OS) for children undergoing TCR αβ+CD3+/CD19+ cell depleted favorably KIR-mismatched haplo-HCT

Transplantation

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: KIR Favorable TransplantExperimental Treatment1 Intervention

To assess in a multi-center setting whether the disease-free survival (DFS) at one-year post-HCT for children with high-risk ALL, AML and MDS can be improved following favorably KIR-mismatched haplo-HCT using a graft ex vivo depleted of T cell receptor (TCR) αβ+CD3+/CD19+ cells from CliniMacs TCR alpha-beta-Biotin system

0 / 5Eligibility criteria met