NCT04099966 AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
| NCT ID | NCT04099966 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mitchell Cairo |
| Condition | Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2021-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.
Eligibility Criteria
Inclusion Criteria: 1. 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 (\<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond; 2. 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 3. 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 ; HL or NHL in CR2 or subsequent remission 5\. Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease) 7. age 0-30 years 8. adequate organ function Exclusion Criteria: 1. Females who are pregnant or breast-feeding are not eligible. 2. Patients with documented uncontrolled infection at the time of study entry are not eligible. 3. Karnofsky/Lansky (age appropriate) Performance Score \<60 4. Demonstrated lack of compliance with medical care 5. Patients who have received allogeneic HSCT within 6 months, unless being done as a boost. 6. Patients with active \<Grade 2 GVHD.
Contact & Investigator
Mitchell S Cairo
STUDY CHAIR
New York Medical College
Frequently Asked Questions
Who can join the NCT04099966 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 30 Years, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04099966 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04099966 currently recruiting?
Yes, NCT04099966 is actively recruiting participants. Contact the research team at mitchell_cairo@nymc.edu for enrollment information.
Where is the NCT04099966 trial being conducted?
This trial is being conducted at Valhalla, United States.
Who is sponsoring the NCT04099966 clinical trial?
NCT04099966 is sponsored by Mitchell Cairo. The principal investigator is Mitchell S Cairo at New York Medical College. The trial plans to enroll 20 participants.
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