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New treatment option for Acute Lymphoblastic Leukemia
Official title Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
ClinicalTrials.gov ID: NCT05800210
What this study is testing
- What it's testing
- This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
- 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 6 to 39
You may be able to join if
- A. Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible: i. 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 of...
- ALL in second remission and beyond ii. AML
- History of AML induction/reinduction Failure (≤15% blasts at time of registration)
- AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)
You likely can't join if
- A. Patients with documented uncontrolled infection
- B. Patients who have received allogeneic hematopoietic stem cell transplantation within 6 months, unless being done as a boost.
- C. Patients with active ≥Grade 2 aGVHD.
- D. Demonstrated lack of compliance with medical care.
- E. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period...
- F. Females who are known to be pregnant or breastfeeding.
See the full eligibility criteria
- A. Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible: i. 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 of registration), mixed phenotype acute leukemia (MPAL), persistent MRD...
- ALL in second remission and beyond ii. AML
- History of AML induction/reinduction Failure (≤15% blasts at time of registration)
- AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)
- AML with persistent minimal residual disease (MRD) in CR1(≥0.01% on flow or persistent abnormal karyotype detected by cytogenetics)
- AML CR2 or beyond
- AML in refractory relapse but ≤15% bone marrow leukemia blasts
- Therapy-related AML iii. Juvenile MyeloMonocytic Leukemia (JMML)
- JMML in CR1 without CBL mutation
- JMML with recurrence of disease with or without CBL mutation
- JMML CR2 or beyond iv. Chronic Myeloid Leukemia (CML) 1\. CML in CR with regard to blast crisis v. High Risk Myelodysplastic syndrome (MDS) vi. Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL)
- HL or NHL with a history of induction failure
- HL or NHL in PR1 or PR2
- HL or NHL in CR2 or subsequent remission B. people must not have more than one active malignancy at the time of enrollment (people with a prior or concurrent malignancy whose natural history or treatment does not have...
- A. Patients with documented uncontrolled infection
- B. Patients who have received allogeneic hematopoietic stem cell transplantation within 6 months, unless being done as a boost.
- C. Patients with active ≥Grade 2 aGVHD.
- D. Demonstrated lack of compliance with medical care.
- E. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 8 weeks after the last dose of study drug.
- F. Females who are known to be pregnant or breastfeeding.
- G. History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy...
- H. Prisoners or people who are incarcerated, or people who are compulsorily detained for treatment of either a psychiatric or physical illness.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, 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, 6 months to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, 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.