Acute Leukemia study: Alpha beta depletion
Official title AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
ClinicalTrials.gov ID: NCT04099966
What this study is testing
What is alpha beta depletion?
alpha beta depletion is an investigational medicine, being studied as a potential treatment for acute leukemia.
Also referred to as α/β CD3+/CD19+ cell depletion.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how removing specific T cells and B cells from the donor stem cells affects the transplant outcome.
- Who it's for
- Children, teens, and young adults with acute leukemia, severe aplastic anemia, non‑Hodgkin or Hodgkin lymphoma, Kostmann syndrome, Diamond‑Blackfan anemia, amegakaryocytic thrombocytopenia, sickle cell disease, or beta‑thalassemia.
- What's involved
- Participants will receive a standard allogeneic stem cell transplant, but the donor cells will be processed to remove alpha/beta T cells and CD19+ B cells before infusion.
- 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 30
You may be able to join if
- ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (\<15% blasts at time...
- AML: History of AML induction/reinduction Failure (\<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e.
- High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2
You likely can't join if
- Females who are pregnant or breast-feeding are not eligible.
- Patients with documented uncontrolled infection at the time of study entry are not eligible.
- Karnofsky/Lansky (age appropriate) Performance Score \<60
- Demonstrated lack of compliance with medical care
- Patients who have received allogeneic HSCT within 6 months, unless being done as a boost.
- Patients with active \<Grade 2 GVHD.
The study team makes the final eligibility decision.
Where it is enrolling
- Valhalla, New York, 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 day to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Valhalla, New York, 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.