CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

February 27, 2020

Primary Completion Date

September 8, 2023

Study Completion Date

September 8, 2023

Conditions
Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromesAcute LeukemiaChronic Myeloid Leukemia
Interventions
DRUG

CD8+ Memory T Cell Infusion

Allogeneic phenotypic CD8+ memory T cells from HLA matched donors infused at the time of hematopoietic cell transplantation

DRUG

Thiotepa

5 mg/kg/day: IV for 2 consecutive days (days -6 to -5)

DRUG

Fludarabine

25 mg/m2/day: IV for 5 consecutive days (days -6 to -2)

RADIATION

Hyperfractionated TBI

Administered in 11 fractions of 125 cGy over 4 days (Total dose of 1375 cGy)

DRUG

Busulfan

6 mg/kg/dose Q24h IV. Infused over 3 hours. 1 dose per day x 4 consecutive days x 3.6 mg/kg/dose = 14.4 mg/kg

DRUG

Cyclophosphamide

60 mg/kg/dose Q24h IV. Infused over 2 hours. 1 dose per day x 2 consecutive days x 60 mg/kg/dose = 120 mg/kg

Trial Locations (1)

94304

Stanford Medical Center, Stanford

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Robert Lowsky

OTHER

NCT04151706 - CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML | Biotech Hunter | Biotech Hunter