Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

[...] (AML) with < 25% marrow blasts. Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia ([ABL)], ambiguous lineage ([ALAL)], mixed phenotype acute leukemia ([MPAL)], blastic plasmacytoid dendritic cell neoplasm ([BPDCN)], and acute undifferentiated leukemia ([AUL], lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia, chronic monocytic leukemia [CML] with blast crisis or other chronic myeloproliferative neoplasm) with < 5% marrow blasts. Myelodysplastic syndrome (MDS) wi [...] and EB-2) and has received cytotoxic induction chemothera [...]

[...] s also receive methotrexate IV on days +1, +3, +6, and +11. Additionally, all patients undergo echocardiography (ECHO) and cerebrospinal fluid (CSF) collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial. After completion of study treatment, patients are followed up periodicallyat days 28, 56, 90, 180, 270, and 365 and then at months 15, 18, 21, and 24.

[...] received cytotoxic induction chemotherapy. Age 6 months to 2226 years at the time informed consent is obtained. Matched related donor (MRD) or matched unrelated donor (MU [...]

[...] and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents). Age 6 months to 22 years at the time informed consent. Matched related donor (MRD) or matched unrelated donor (MUD) [...] t at 8/8 HLA alleles (HLA-A, -B, -C, and -DRB1) DONOR: Be >=1814 years of age. DONOR: Must be available to donate in the Uni [...] al Marrow Donor Program (NMDP) donor regulatory requirements. Must meet eligibility criteria as defined by the NMDP or be [...] nt of urgent medical need (exception 21 CFR 1271.65(b)(iii)). Tests must be performed using Food and Drug Administ [...] [...]

University of Iowa/Holden SteadComprehensive FamilyCancer Children's HospitalCenter

[...] tis B, hepatitis C (serological and/or nucleic acid testing ([NAT)] and/or other approved testing) Must meet institutional dono [...] ust be cleared by the end of the pre-conditioning evaluation time frame. If CNS disease is identified on the first cerebrospinal fl [...]

[...] ys -10 to -7, then receive thiotepa intravenously (IV) over 43 hours once daily (QD) on days -6 and -5, and fludarabine IV [...]

[...] appropriate candidate for allogeneic HCT by the study site Principalprincipal Investigatorinvestigator (PI): Acute lymphoblastic leukemia (ALL) with < 5% marrow b [...]

[...] on related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to [...] requested) (applicable only to the RCT phase of this study)). DONOR: MUDs: Must give informed consent according to appli [...] NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii)). Tests must be performed using Food and Drug Administration [...] -lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and/or nucleic acid testing (NAT) and/or other [...] tatement that the donor is a first or second degree relative (exception 21 CR [...] [...]

ParticipantsPatients are randomized to 1 of 2 arms. All participantspatients receive 1 of 3 conditioning regimens. CONDITIONING REGIMEN A: ParticipantsPatients undergo total body irradiation (TBI) twice daily (BID) on d [...] inutes once daily on days -6 to -2. CONDITIONING REGIMEN B: ParticipantsPatients undergo TBI BID on days -8 to -5, then receive fludarabine [...] V over 1 hour QD on days -3 and -2. CONDITIONING REGIMEN C: ParticipantsPatients receive fludarabine IV over 30 minutes QD on days -6 to -2, [...] 2, and undergo total body irradiation BID on day -1. ARM I: ParticipantsPatients receive naive T-cell [...] [...]