Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2025-07-29
15
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent and assent if appropriate
- Age 18 years or older; patients 18 to under 60 years with a comorbidity index of 2 or higher are also eligible
- Karnofsky performance status of 70 or higher
- Histologically confirmed diagnosis of high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome meeting specific risk criteria
- Creatinine clearance of 60 ml/min or higher measured within 30 days before therapy
- Serum bilirubin 2.0 mg/dl or lower measured within 30 days before therapy
- Serum SGOT and SGPT no more than 2.5 times the institutional upper limit of normal measured within 30 days before therapy
- Ejection fraction of 50% or higher measured by echocardiogram or MUGA within 30 days before therapy
- Lung diffusion capacity (DLCO) greater than 50% predicted within 30 days before therapy
- Forced expiratory volume in 1 second (FEV1) greater than 50% predicted within 30 days before therapy
- Agreement to use effective birth control or abstain from heterosexual activity during and at least 6 months after treatment if of childbearing potential
- Have an HLA identical sibling donor or a 10/10 allele matched unrelated donor willing to donate peripheral blood stem cells or bone marrow
You will not qualify if you...
- Prior allogeneic transplant
- Prior radiation treatment to lung, liver, or kidney
- Prior radiopharmaceutical therapy
- More than 3 prior treatment regimens for leukemia or myelodysplastic syndrome intended to induce remission
- Receiving other investigational agents or intensive chemotherapy or radiation within 2 weeks before conditioning
- Allergic reactions to similar compounds as the study drug
- Active other malignancies except non-melanoma skin cancers
- Uncontrolled illness including active infections
- Medical or psychiatric conditions impairing ability to comply or tolerate transplant
- Pregnancy or breastfeeding
- Any condition contraindicating participation due to safety concerns
- Inability to comply with study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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