Who may be eligible for this high-risk leukemia and myelodysplastic syndrome clinical trial?

Adults aged 18 to 70 years diagnosed with high-risk AML, ALL, or MDS who show CD38 expression on their cancer cells may be eligible. Participants must not have had prior allogeneic transplant or radiotherapy and should be medically fit with good organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this high-risk leukemia and myelodysplastic syndrome clinical trial?

Study-related care, including the study drug, procedures, and trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years - 70Years

All Genders

ID06287944

Phase I Study of 225Ac-DOTA-Anti-CD38 Daratumumab Combined With Fludarabine, Melphalan, and Targeted Total Marrow and Lymphoid Irradiation as Conditioning for Donor Stem Cell Transplant in High-Risk AML, ALL, and MDS

Q: What is 225Ac-DOTA-Anti-CD38 daratumumab studying for high-risk leukemia and myelodysplastic syndrome?

This trial is studying how well the drug 225Ac-DOTA-Anti-CD38 daratumumab works with chemotherapy and targeted radiation as a preparation for stem cell transplant in patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndrome. The research aims to find the best dose and monitor safety and side effects under medical supervision.

Led by City of Hope Medical Center · Updated on 2026-07-31

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, side effects, best dose, and effectiveness of a combination conditioning treatment for donor stem cell transplantation in patients with high-risk acute myeloid leukemia AML, acute lymphoblastic leukemia ALL, and myelodysplastic syndrome MDS. This phase I trial studies a targeted radioimmunotherapy drug, 225Ac-DOTA-Anti-CD38 daratumumab, combined with chemotherapy drugs fludarabine and melphalan, and total marrow and lymphoid irradiation TMLI. Daratumumab targets CD38 on cancer and immune cells, potentially helping the immune system to attack cancer cells. Participants receive daratumumab intravenously followed by indium In 111-DOTA-daratumumab and actinium Ac 225-DOTA-daratumumab on day -15. Total marrow and lymphoid irradiation is given twice daily from days -8 to -5, fludarabine is given intravenously on days -4 to -2, and melphalan on day -2. On day 0, participants undergo hematopoietic cell transplantation HCT. Graft-versus-host disease GVHD prevention with sirolimus and tacrolimus starts on day -1. Throughout the study, participants undergo various scans, biopsies, and blood tests to monitor treatment effects and safety. Participants are monitored closely after transplantation with visits twice weekly for the first 100 days, then twice monthly up to six months, and monthly thereafter until immunosuppressive therapy is stopped without GVHD signs. Yearly follow-up continues for two years. Assessments include adverse events, survival rates, relapse, graft-versus-host disease incidence, infections, blood cell recovery, organ function, and drug distribution. The study aims to determine the maximum tolerated dose and evaluate overall safety and effectiveness of the treatment combination.

CONDITIONS

Brief 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

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Documented informed consent from participant or legal representative
Age between 18 and less than 70 years
Karnofsky performance status of 70 or higher
Confirmed diagnosis of high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome with specific risk features
Evidence of CD38 expression on cancer cells by flow cytometry or equivalent assay
Adequate organ function including creatinine clearance ≥ 60 ml/min, bilirubin ≤ 2.0 mg/dl, liver enzymes ≤ 2.5 times upper normal limit
Ejection fraction by echocardiogram or MUGA ≥ 50%
Lung function tests (DLCO and FEV1) greater than 50% predicted
Agreement to use effective birth control or abstain from heterosexual activity during the study and for 6 months after
Availability of a suitable HLA-matched stem cell donor as per study requirements

You will not qualify if you...

Prior allogeneic stem cell transplant
Prior radiotherapy or radiopharmaceutical therapy
Receiving other investigational agents or intensive chemotherapy/radiation within 2 weeks before conditioning
Allergy to compounds similar to study drug
Other active cancers except non-melanoma skin cancers
Uncontrolled infections or illnesses
Medical or psychiatric conditions interfering with study compliance or transplant tolerance
Pregnant or breastfeeding females
Any other condition deemed unsafe by the investigator
Inability to comply with study procedures due to feasibility or logistics

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Phase I Study of 225Ac-DOTA-Anti-CD38 Daratumumab Combined With Fludarabine, Melphalan, and Targeted Total Marrow and Lymphoid Irradiation as Conditioning for Donor Stem Cell Transplant in High-Risk AML, ALL, and MDS

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria