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
Phase 1
15
about 2.9 years
18+
1 site in CA
What this study is about
This trial is testing the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is a type of medication called monoclonal antibody that binds to a protein called CD38, which is found on some types of immune cells and cancer cells. This treatment may block CD38 and help the immune system kill cancer cells.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Actinium Ac 225-DOTA-Daratumumab
- 2.Receive Daratumumab
- 3.Receive Indium In 111-DOTA-Daratumumab
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
daratumumab, fludarabine, melphalan, sirolimus, tacrolimus
infusion, injection, intravenous
Primary: Dose limiting toxicity (DLT), Incidence of adverse events (Bearman), Incidence of adverse events (CTCAE), Maximum tolerated dose/recommended phase II dose (MTD/RP2D)
Secondary: Complete remission (CR) proportion, Event-free survival (EFS), Graft versus host disease and relapse free survival (GRFS), Non-relapse mortality (NRM), Overall survival (OS)
diagnostic, biopsy, imaging, radiation
Oncology