OncoMatch/Clinical Trials/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
Is NCT06287944 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for acute lymphoblastic leukemia.
Treatment: Actinium Ac 225-DOTA-Daratumumab · Daratumumab · Fludarabine · Indium In 111-DOTA-Daratumumab · Melphalan · Sirolimus · Tacrolimus — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: CD38 expression (testing required; no eligibility threshold specified)
Evidence of CD38 expression by flow cytometry AND one of the below ... All patients must demonstrate CD38 expression on disease-relevant cell populations (bone marrow and/or peripheral blood) as assessed by flow cytometry or an equivalent validated assay prior to enrollment.
Demographics
Prior therapy
Cannot have received: allogeneic transplant
Patients who had a prior allogeneic transplant
Cannot have received: radiotherapy
Patients who have had prior radiotherapy
Cannot have received: radiopharmaceutical therapy
Patients who have received prior radiopharmaceutical therapy
Lab requirements
Kidney function
creatinine clearance ≥ 60 ml/min
Liver function
serum bilirubin ≤ 2.0 mg/dl; SGOT ≤ 2.5x ULN; SGPT ≤ 2.5x ULN
Cardiac function
ejection fraction ≥ 50% by echocardiogram or MUGA
A pretreatment measured creatinine clearance (absolute value) of ≥ 60 ml/minute ... serum bilirubin ≤ 2.0 mg/dl ... SGOT ≤ 2.5x ULN ... SGPT ≤ 2.5x ULN ... Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) ≥ 50% ... DLCO > 50% predicted ... FEV1 > 50% predicted
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06287944 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic transplant, radiotherapy, radiopharmaceutical therapy disqualifies patients from enrollment.
Does this trial require CD38?
Yes, CD38 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify