# 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

> **NCT06287944** · PHASE1 · RECRUITING · sponsor: **City of Hope Medical Center** · enrollment: 15 (estimated)

## Conditions studied

- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome

## Interventions

- **BIOLOGICAL:** Actinium Ac 225-DOTA-Daratumumab
- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Bone Marrow Aspiration
- **PROCEDURE:** Bone Marrow Biopsy
- **PROCEDURE:** Computed Tomography
- **BIOLOGICAL:** Daratumumab
- **PROCEDURE:** Echocardiography
- **DRUG:** Fludarabine
- **PROCEDURE:** Hematopoietic Cell Transplantation
- **BIOLOGICAL:** Indium In 111-DOTA-Daratumumab
- **DRUG:** Melphalan
- **PROCEDURE:** Multigated Acquisition Scan
- **PROCEDURE:** Radionuclide Imaging
- **PROCEDURE:** Single Photon Emission Computed Tomography
- **DRUG:** Sirolimus
- **DRUG:** Tacrolimus
- **RADIATION:** Total Marrow and Lymphoid Irradiation

## Key facts

- **NCT ID:** NCT06287944
- **Lead sponsor:** City of Hope Medical Center
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-07-01
- **Primary completion:** 2028-05-19
- **Final completion:** 2028-05-19
- **Target enrollment:** 15 (ESTIMATED)
- **Last updated:** 2026-05-18

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06287944

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06287944, "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". Retrieved via AI Analytics 2026-07-11 from https://api.ai-analytics.org/clinical/NCT06287944. Licensed CC0.

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