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Cell Therapy

Stem Cell Addback for Leukemia

N/A
Recruiting
Led By Tim Olson, MD
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
Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia
Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days post-transplantation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia is at high risk of coming back or has already relapsed.
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My organs are healthy and I don't have infections, as per the bone marrow transplant guidelines.
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I am younger than 25 years old.
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I have had only one bone marrow transplant from a donor.
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I am over 18 and can consent, or my guardian has consented for me.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of acute graft vs. host disease (GVHD)

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).

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
706 Previous Clinical Trials
8,571,390 Total Patients Enrolled
Tim Olson, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
Nancy Bunin, MDPrincipal Investigator - Children's Hospital of Philadelphia
Children's Hospital of Philadelphia, Children's Seashore House of the Childrens Hospital of Phila, Children's Surgical Associates of New Jersey Inc
University Of Cincinnati College Of Medicine (Medical School)
University Of Mi Hosps (Residency)
3 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03810196 — N/A
Acute Leukemia Research Study Groups: TBI regimen, TBI or busulfan regimen
Acute Leukemia Clinical Trial 2023: TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback Highlights & Side Effects. Trial Name: NCT03810196 — N/A
TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03810196 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the limit to patient enrollment in this trial?

"Yes, the latest data on clinicaltrials.gov indicates that this research initiative has resumed their search for participants. This trial was first posted on March 1st 2019 and its most recent update happened on March 21st 2022; they are in need of 30 patients from a single medical centre."

Answered by AI

Are researchers still accepting participants for this clinical experiment?

"Indeed, information accessible on clinicaltrials.gov confirms that this investigation is currently recruiting participants. Initially posted on March 1st 2019 and recently updated on March 21st 2022, the trial requires 30 volunteers across a single site."

Answered by AI
~7 spots leftby Feb 2025