Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 31, 2019

Primary Completion Date

September 26, 2023

Study Completion Date

September 30, 2024

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Gemtuzumab Ozogamicin (GO)

Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.

OTHER

Donor Leukocytes

The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.

Trial Locations (1)

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Rhode Island Hospital

OTHER

collaborator

The Miriam Hospital

OTHER

collaborator

Pfizer

INDUSTRY

lead

Brown University

OTHER