NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 7, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions

Allogeneic Hematopoietic Cell Transplantation (HCT)Advanced Hematologic MalignanciesAcute LeukemiaChronic Myelogenous LeukemiaMyelodysplastic SyndromesMyeloproliferative Disorders

Interventions

DRUG

Purified regulatory T-cells (Treg) plus CD34+ HSPC

"Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells (CD34+ HSPC), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10\^6 cells/ kg to 3x10\^6 cells/kg"

DRUG

Fludarabine

Fludarabine (160 mg/m2)

DRUG

Melphalan

Melphalan (50 mg/m2)

DEVICE

CliniMACS CD34 Reagent System

The CliniMACS® CD34 Reagent System is a medical device that is used in vitro to select and enrich specific cell populations is manufactured by Miltenyi Biotec

DRUG

Tacrolimus

4-6ng/mL

DRUG

Cyclophosphamide

40mg/kg

DRUG

Plerixafor

Dose 0.24 mg/kg, manufactured by Genzyme

DRUG

Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent

Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL

DRUG

Thiotepa

Thiotepa 10 mg/kg

DRUG

Mycophenolate Mofetil (MMF)

MMF 1000 mg BID

DRUG

Ruxolitinib

Ruxolitinib 5 mg BID

Trial Locations (1)

94304

RECRUITING

Stanford University, Stanford