Phase II Trial of Individualized Pk-Targeted Preparative Approaches in TCRaB/CD19 Depleted HCT

Study of Personalized Conditioning Before Haploidentical Stem Cell Transplant in Children With High-Risk Blood Cancers

Age
17 years or below
Gender
All
Phase
Phase 2
Participants needed
3
Primary Investigator
JB

Jonathan Bardahl

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Brief description of study

To evaluate the effectiveness of individually targeted, model-based dosing of serotherapy and chemotherapy conditioning on two-year post-HCT DFS in children with high-risk ALL, AML, MDS, or other hematological malignancies who are MRD-negative at the time of ex vivo TCRαβ+/CD19+-depleted haploidentical HCT

To evaluate the effectiveness of individually targeted, model-based dosing of serotherapy and chemotherapy conditioning on two-year post-HCT DFS in children with high-risk ALL, AML, MDS, or other hematological malignancies who are MRD-positive at the time of ex vivo TCRαβ+/CD19+-depleted haploidentical HCT.

To characterize overall survival (OS), graft-versus-host disease (GVHD)-free relapse-relapse free survival (GRFS), and chronic graft-versus-host disease-free relapse-free survival (CGRFS) at 2-year post-HCT for children following model-based dosing of serotherapy and chemotherapy conditioning followed by ex vivo TCRαβCD3+/CD19+ depleted HCT.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at Indiana University Simon Comprehensive Cancer Center (IUSCCC), please contact the IU Clinical Trials Office at:
Phone: (317) 278-5632

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: ALL, AML, MDS, or other hematological malignancies, Cancer, Riley
  • Age: 17 years or below
  • Gender: All

The purpose of this research study is to learn about the effects of using individualized (personalized) dosing of conditioning treatment before a specific type of stem cell transplant in children with high-risk blood cancers. The study includes children with diseases such as acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or other blood cancers who are having a haploidentical stem cell transplant (a transplant from a half-matched family donor). The study includes children who are either MRD-negative or MRD-positive at the time of transplant (MRD means “minimal residual disease,” or very small amounts of cancer cells that can remain after treatment).

Participants will receive conditioning treatment that includes serotherapy and chemotherapy. In this study, the doses of these medicines are individually targeted using a model-based approach (a method that uses a dosing model to help tailor the dose to the individual). Participants will then receive a haploidentical stem cell transplant in which the donor cells are processed outside the body to remove certain immune cells (TCRαβ and CD19 cells) before the transplant.

Who can participate:
This study is enrolling by invitation only.
Children with high-risk ALL, AML, MDS, or other blood cancers may be able to participate if they:

  • Are having a haploidentical stem cell transplant with donor cells that are processed to remove TCRαβ and CD19 cells
  • Are MRD-negative or MRD-positive at the time of transplant

Updated on 15 Oct 2026. Study ID: 33151

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