Stem Cell Addback for Leukemia

N/A

Recruiting

Led By Timothy Olson, MD, PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days post-transplantation

Awards & highlights

No Placebo-Only Group

Summary

This trial found that adding back naive T cells to a stem cell transplant from a matched sibling donor may improve immune reconstitution and help decrease the risk of infections.

Who is the study for?

This trial is for patients under 25 years old who are undergoing their first allogeneic HSCT and have high-risk acute leukemias or certain hematologic malignancies. They must meet specific health criteria and be able to consent if over 18. It's not for those with Hodgkin lymphoma, non-Burkitts/non-lymphoblastic lymphomas, genetic disorders like Fanconi anemia, or without a suitable stem cell donor.

What is being tested?

The trial tests the CliniMACS Cell Processing System for TCRαβ+ T Cell/CD45RA Depleted Peripheral Stem Cell Addback post-transplant to prevent GVHD while reducing infection risks by potentially improving immune reconstitution in young patients with leukemia or other related conditions.

What are the potential side effects?

Potential side effects may include reactions related to stem cell infusion such as fever, chills, pain at injection site; risk of GVHD despite depletion techniques; and complications from delayed immune system recovery leading to infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days post-transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days post-transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days post-transplantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of acute graft vs. host disease (GVHD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TBI regimenExperimental Treatment1 Intervention

Standard of care myeloablative regimens will be used based on disease type and clinical status at time of transplant. Patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma will receive total body irradiation (TBI) regimen (thiotepa, cyclophosphamide, TBI).

Group II: TBI or busulfan regimenExperimental Treatment1 Intervention

Standard of care myeloablative regimens will be used based on disease type and clinical status at time of transplant. Patients not diagnosed with ALL or lymphoblastic lymphoma may receive either total body irradiation (TBI) regimen (thiotepa, cyclophosphamide, TBI) or busulfan containing regimen (thiotepa, cyclophosphamide, busulfan).

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