← Back to Search

Radioimmunotherapy

Daratumumab Combination Therapy for High-Risk Leukemia

Phase 1

Recruiting

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-transplant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity (DLT)

Incidence of adverse events (Bearman)

Incidence of adverse events (CTCAE)

+1 more

Secondary study objectives

Complete remission (CR) proportion

Cumulative incidence of relapse/progression (CIR)

Event-free survival (EFS)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Computed Tomography

2017

Completed Phase 2

~2790