NCT04151706

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

CD34 Selected Allogeneic Hematopoietic Cell Transplantation With Myeloablative Conditioning and CD8+ Memory T Cell Infusion For Patients With Myelodysplastic Syndrome, Acute Leukemia, and Chronic Myelogenous Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Robert Lowsky · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.

Detailed description

Primary Objective: To determine the rate of graft versus host disease (GvHD) free, relapse free survival (GRFS) at one year following CD34 selected allogeneic hematopoietic cell transplantation using myeloablative conditioning combined with an infusion of phenotypic CD8+ memory T cells from human leukocyte antigen (HLA) matched donors for patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML). Secondary Objective: To determine the rate of graft rejection, acute and chronic GvHD, non relapse mortality, relapse, overall survival, and disease free survival.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndromes
• Acute Leukemia
• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-27
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2019-11-05
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study