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

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

NCT ID: NCT05735717

Condition: Hematologic Malignancy
Acute Leukemia
Remission
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
AML
TP53
Intrachromosomal Amplification of Chromosome 21
Cytogenetic Abnormality
CNS Leukemia
Minimal Residual Disease
Myelodysplasia
Juvenile Myelomonocytic Leukemia
Somatic Mutation
PTPN11 Gene Mutation
N-RAS Gene Amplification
Neurofibromatosis 1
NF1 Mutation
CBL Gene Mutation
Monosomy 7
Chromosome Abnormality
Fetal Hemoglobin

Conditions: Official terms:
Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Neurofibromatoses
Neurofibromatosis 1
Neoplasm, Residual
Leukemia, Myelomonocytic, Juvenile
Congenital Abnormalities
Chromosome Disorders
Chromosome Aberrations
Monosomy
Rituximab
Fludarabine
Melphalan
Busulfan
Levetiracetam

Conditions: Keywords:
Bu
Flu
G-CSF
GFSR
aGVHD
HCT
MAC
Mel
PBSCT
PTLD
RECIST
TCR

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Fludarabine
Description: Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Arm group label: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
Arm group label: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
Arm group label: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen

Intervention type: Drug
Intervention name: Busulfan
Description: Busulfan 82.1 mg*hr/L IV on days -5 to -2 or days -8 to -5
Arm group label: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
Arm group label: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only

Intervention type: Drug
Intervention name: Melphalan
Description: Melphalan 50 mg/m2 IV on days -4 to -2
Arm group label: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only

Intervention type: Drug
Intervention name: Rituximab
Description: 200 mg/m2 intravenous given once on day-1
Arm group label: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
Arm group label: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
Arm group label: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen

Intervention type: Drug
Intervention name: Levetiracetam
Description: 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.
Arm group label: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
Arm group label: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only

Other name: Keppra

Summary: 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

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: N/A

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Minnesota Masonic Cancer Center

Address:
City: Minneapolis
Zip: 55455
Country: United States

Status: Recruiting

Contact:
Last name: Margaret MacMillan

Start date: May 11, 2023

Completion date: November 30, 2030

Lead sponsor:
Agency: Masonic Cancer Center, University of Minnesota
Agency class: Other

Source: Masonic Cancer Center, University of Minnesota

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05735717