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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase I trial tests 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 in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Uczestnik lub jego prawny opiekun wyraża świadomą zgodę na udział w badaniu.
- •Wiek 70 lat lub więcej. Pacjenci w wieku 18-70 lat z aktywną, nawracającą lub oporną ostrą białaczką lub MDS o wysokim ryzyku również mogą być włączeni.
- •Ogólny stan zdrowia dobry (minimum 70 punktów w skali Karnofsky'ego).
- •Potwierdzona diagnoza jednego z następujących nowotworów krwi: ostra białaczka szpikowa, zespół mielodysplastyczny (w kategoriach wysokiego ryzyka) lub ostra białaczka limfoblastyczna.
- •Choroba ostrej białaczki szpikowej lub ostrej białaczki limfoblastycznej w grupach ryzyka uważanych za niekorzystne, lub która jest oporna na leczenie.
- •Obecność markera CD38 na komórkach nowotworowych.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- July 31, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
City of Hope Medical Center
Duarte, United States
Trial contact
Jeffrey Y. Wong
Jeffrey Y. Wong
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
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