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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735717
• Other study ID #: 2021LS061
• Status: Recruiting
• Phase: Phase 2
• Start date: May 11, 2023
• Est. completion date: November 30, 2030

Study information

• Verified date: October 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Margaret MacMillan
• Phone: 612-626-2961
• Email: macmi002[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 30, 2030
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• AML
• Chromosome Aberrations
• Chromosome Abnormality
• Chromosome Disorders
• Congenital Abnormalities
• Cytogenetic Abnormality
• Fetal Hemoglobin
• Hematologic Malignancy
• Hematologic Neoplasms
• Juvenile Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelomonocytic, Juvenile
• Minimal Residual Disease
• Monosomy 7
• Myelodysplasia
• Neoplasm, Residual
• Neoplasms
• Neurofibromatoses
• Neurofibromatosis 1
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Remission
• Somatic Mutation
• TP53

Intervention

Drug:
• Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
• Busulfan
Busulfan 82.1 mg*hr/L IV on days -5 to -2 or days -8 to -5
• Melphalan
Melphalan 50 mg/m2 IV on days -4 to -2
• Rituximab
200 mg/m2 intravenous given once on day-1
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the rate of GVHD after alpha beta TCR depletion	GVHD incidence after treatment.	85 months
Secondary	Transplant engraftment	Monitor median rate of engraftment by 42 days.	42 days
Secondary	Graft Failure	Determine the rate of graft failure by day 100 (defined as lack of achievement of an ANC >=500/mL with associated pancytopenia)	100 days
Secondary	Non-relapse mortality (NRM)	Determine the incidence of non-relapse mortality (NRM) at 100 days and 1 year	12 months
Secondary	Overall survival (OS)	Number of participants experiencing progression free survival at one year follow up	12 months