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New treatment option for Acute Leukemia
Official title CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT
ClinicalTrials.gov ID: NCT03810196
What this study is testing
- What it's testing
- The major morbidities of allogeneic hematopoietic stem cell transplant with non-human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life threatening infections. T depletion of the donor hematopoietic stem cell graft is effective in preventing GVHD, but immune reconstitution is slow, increasing the risk of infections.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 25
You may be able to join if
- Age: Patients \<25 years.
- First allogeneic HSCT only.
- Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk...
- Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).
- Signed consent by parent/guardian or able to give consent if \>18 years.
You likely can't join if
- Patients who do not meet institutional disease, organ or infectious criteria
- No suitable donor available for mobilized peripheral stem cells
- Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.
- Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma
- Pregnant Participants Donor selection and eligibility
- Unrelated donor meets National Marrow Donor Program criteria for donation
See the full eligibility criteria
- Age: Patients \<25 years.
- First allogeneic HSCT only.
- 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...
- Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).
- Signed consent by parent/guardian or able to give consent if \>18 years.
- Patients who do not meet institutional disease, organ or infectious criteria
- No suitable donor available for mobilized peripheral stem cells
- Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.
- Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma
- Pregnant Participants Donor selection and eligibility
- Unrelated donor meets National Marrow Donor Program criteria for donation
- HLA testing/matching
- Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection
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, up 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.
Explore other conditions
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.