RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Histological confirmation of hematological malignancies - Acute leukemias - Acute Myeloid Leukemia (AML) and related precursor neoplasms - Favorable risk AML is defined as having one of the following: - Acute lymphoblastic leukemia (ALL)/lymphoma - Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. - Age 60 years of age or younger at the time of consent - Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age. - your organs (liver, kidneys, etc.) are working well enough based on blood tests Who Should NOT Join This Trial: - Pregnant or breastfeeding. - Active uncontrolled infection within 1 week of starting preparative therapy - Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR. - Any prior autologous or allogeneic transplant - CML blast crisis - Active central nervous system malignancy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Histological confirmation of hematological malignancies * Acute leukemias * Acute Myeloid Leukemia (AML) and related precursor neoplasms * Favorable risk AML is defined as having one of the following: * Acute lymphoblastic leukemia (ALL)/lymphoma * Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. * Age 60 years of age or younger at the time of consent * Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age. * Adequate organ function Exclusion Criteria: * Pregnant or breastfeeding. * Active uncontrolled infection within 1 week of starting preparative therapy * Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR. * Any prior autologous or allogeneic transplant * CML blast crisis * Active central nervous system malignancy

Treatments Being Tested

DRUG

Fludarabine

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

DRUG

Busulfan

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

DRUG

Melphalan

Melphalan 50 mg/m2 IV on days -4 to -2

DRUG

Rituximab

200 mg/m2 intravenous given once on day-1

DRUG

Levetiracetam

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.

BIOLOGICAL

Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells

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

DRUG

Thymoglobulin

rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2

Locations (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States