Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Nervous System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Congenital Abnormalities

Influenza, Human

Hematologic Neoplasms

Neoplasm, Residual

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Chromosome Aberrations

Monosomy

Chromosome Disorders

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplastic Processes

Bone Marrow Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Aneuploidy

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Neurofibromatosis

Neurofibromatosis Type 1

Lymphosarcoma

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anticonvulsants

Nootropic Agents

Fludarabine

Fludarabine phosphate

Rituximab

Melphalan

Levetiracetam

Busulfan

Antineoplastic Agents, Immunological

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.

Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.

Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5

200 mg/m2 intravenous given once on day-1

As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.

Margaret MacMillan

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies

MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies

For the purposes of data and safety monitoring, this study is classified as high risk (investigator initiated under an IND). Therefore the following requirements will be fulfilled:

* The Masonic Cancer Center Data and Safety Monitoring Council (DSMC) will review the study's progress at least quarterly.
* The PI will comply with at least twice yearly monitoring of the project by the Masonic Cancer Center monitoring services.
* The PI will oversee the submission of all reportable adverse events per the definition of reportable in Section 11.5 to the Masonic Cancer Center's SAE Coordinator, the University of Minnesota IRB, and the FDA.

Monitor median rate of engraftment by 42 days.

Determine the rate of graft failure by day 100 (defined as lack of achievement of an ANC \>=500/mL with associated pancytopenia)

Determine the incidence of non-relapse mortality (NRM) at 100 days and 1 year

Number of participants experiencing progression free survival at one year follow up

Masonic Cancer Center, University of Minnesota

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