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New treatment option for Leukemia
Official title Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
ClinicalTrials.gov ID: NCT06839456
What this study is testing
- What it's testing
- The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Disease for which allogeneic HSCT may be curative.
- Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice...
- Patients must be 25 years of age and less
- Evaluation for organ and infectious status as per our CTTS standard operating procedure.
- Signed consent by parent/guardian or able to give consent if 18 years of age and older.
You likely can't join if
- Patients who have performance score less than 60.
- No suitable donor available for mobilized peripheral stem cells.
- Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.
- Planned receipt of alemtuzumab during conditioning.
- Patients with an available 10/10 HLA matched sibling donor.
- Patients who do not meet institutional disease, organ or infectious criteria. Donor selection and eligibility:
See the full eligibility criteria
- Disease for which allogeneic HSCT may be curative.
- Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS).
- Patients must be 25 years of age and less
- Evaluation for organ and infectious status as per our CTTS standard operating procedure.
- Signed consent by parent/guardian or able to give consent if 18 years of age and older.
- Participants of childbearing potential must have a negative pregnancy test as per institutional SOP.
- Patients who have performance score less than 60.
- No suitable donor available for mobilized peripheral stem cells.
- Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.
- Planned receipt of alemtuzumab during conditioning.
- Patients with an available 10/10 HLA matched sibling donor.
- Patients who do not meet institutional disease, organ or infectious criteria. Donor selection and eligibility:
- Unrelated donor meets National Marrow Donor Program criteria for donation.
- Related donor (at least haploidentical) willing and able to donate mobilized peripheral stem cells.
- HLA testing/matching
- HLA testing to be done by molecular methods for A, B, C, DRB1, DQB1
- Related donor: Must be ≥ 5/10 match
- Unrelated donor: 10/10 or 9/10 match
- KIR typing for haploidentical donor for hematologic malignancies
- Donor specific HLA antibodies (DSA) should be assessed for all people receiving an HLA mismatched graft (≤ 9/10).
- Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection
- Donors must be willing to sign consent to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.