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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
Be younger than 65 years old
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.
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
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).
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
710 Previous Clinical Trials
8,588,858 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is at high risk of coming back or has already relapsed.My organs are healthy and I don't have infections, as per the bone marrow transplant guidelines.I am younger than 25 years old.I have had only one bone marrow transplant from a donor.I am over 18 and can consent, or my guardian has consented for me.I have a genetic disorder related to DNA repair, like Fanconi anemia.I don't have a matching donor for a stem cell transplant.I have Hodgkin lymphoma or a type of non-Burkitts, non-lymphoblastic lymphoma.I meet my hospital's health standards for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: TBI regimen
- Group 2: TBI or busulfan regimen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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