NCT06287944View on ClinicalTrials.gov

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

May 19, 2028

Study Completion Date

May 19, 2028

Conditions
Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndrome
Interventions
BIOLOGICAL

Actinium Ac 225-DOTA-Daratumumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Daratumumab

Given IV

PROCEDURE

Echocardiography

Undergo echocardiography

DRUG

Fludarabine

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Undergo SCT

BIOLOGICAL

Indium In 111-DOTA-Daratumumab

Given IV

DRUG

Melphalan

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Radionuclide Imaging

Undergo nuclear scan

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT scan

DRUG

Sirolimus

Given sirolimus

DRUG

Tacrolimus

Given tacrolimus

RADIATION

Total Marrow and Lymphoid Irradiation

Undergo TMLI

Trial Locations (1)

91010

RECRUITING

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER