RecruitingPhase 2

AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

United States20 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range1 Day – 30 Years

SexALL

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Inclusion criteria

✓. 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;
✓. 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
✓. 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

Exclusion criteria

✕. 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.

What they're measuring

incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells

Timeframe: 1 year

Trial details

NCT IDNCT04099966

SponsorMitchell Cairo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Mitchell S Cairo, MD

9145942150 mitchell_cairo@nymc.edu

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