Leukemia study: Phase
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 study wants to see if adding back memory T cells speeds up immune recovery and lowers infection risk after a transplant that removes certain T and B cells.
- Who it's for
- It is looking for adults who have leukemia, myelodysplastic syndrome, lymphoma, aplastic anemia, or other blood or immune disorders and are scheduled for an allogeneic stem cell transplant from a non‑matched donor.
- What's involved
- Participants will receive a modified stem cell graft that has had specific T and B cells removed, plus a small portion of memory T cells added back. They will have regular blood tests and clinic visits to monitor immune function and infections.
- Time commitment
- The study lasts about 12 months after transplant, with visits at transplant, 1, 3, 6, 9, and 12 months to check health and immune status.
- 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.
- Unrelated donor meets National Marrow Donor Program criteria for donation.
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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.