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Radioimmunotherapy

Treatment ( Actinium Ac 225-DOTA-Daratumumab) for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Jeffrey Y Wong
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-transplant
Awards & highlights

Study Summary

"This trial is testing a new combination treatment for patients with high-risk leukemia and myelodysplastic syndrome before they undergo a stem cell transplant. The treatment includes a medication called daratumumab

Who is the study for?
This trial is for patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) who are candidates for donor stem cell transplant. Specific eligibility criteria were not provided, but typically include factors like age, overall health status, and the specifics of their cancer diagnosis.Check my eligibility
What is being tested?
The trial tests a new treatment combining 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody with chemotherapy drugs fludarabine and melphalan, plus total marrow and lymphoid irradiation (TMLI). It aims to find the safest dose that's also effective as pre-transplant conditioning in high-risk AML, ALL, and MDS patients.See study design
What are the potential side effects?
Potential side effects may include reactions to the monoclonal antibody such as infusion-related symptoms; damage to organs from radiation; side effects from chemotherapy like nausea, fatigue, hair loss; increased risk of infections due to immune system suppression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT)
Incidence of adverse events (Bearman)
Incidence of adverse events (CTCAE)
+1 more
Secondary outcome measures
Complete remission (CR) proportion
Cumulative incidence of relapse/progression (CIR)
Event-free survival (EFS)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ( Actinium Ac 225-DOTA-Daratumumab)Experimental Treatment17 Interventions
Patients receive daratumumab IV over 45 minutes followed by indium In 111-DOTA-daratumumab IV over 15 minutes and actinium Ac 225-DOTA-daratumumab IV over ~20-40 minutes on day -15. Patients receive TMLI BID on days -8 to -5, fludarabine IV on days -4 to -2 and melphalan IV on day -2, followed by HCT on day 0. Patients receive GVHD prophylaxis with sirolimus and tacrolimus starting on day -1. Patients also undergo CT during screening, nuclear scan and SPECT scans on study, bone marrow biopsy and aspiration, echocardiography, or MUGA, and blood sample collection during screening and throughout study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1990
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Fludarabine
2012
Completed Phase 3
~1080
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Melphalan
2008
Completed Phase 3
~1500
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Radionuclide Imaging
2004
Completed Phase 2
~50
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Sirolimus
2013
Completed Phase 4
~2750
Tacrolimus
2011
Completed Phase 4
~4740

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,601 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,349 Total Patients Enrolled
Jeffrey Y WongPrincipal InvestigatorCity of Hope Medical Center
8 Previous Clinical Trials
210 Total Patients Enrolled
~10 spots leftby Feb 2027
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