Daratumumab for Hemolytic Anemia
(DARA-AIHA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.
Who Is on the Research Team?
Matthew Sullivan, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
Adults with confirmed autoimmune hemolytic anemia who have tried steroids and rituximab without success are eligible for this trial. They must not have severe kidney failure, recent heart issues, uncontrolled medical conditions, active infections like HIV or Hepatitis B/C, certain lung diseases, end-stage liver disease, active lupus with systemic involvement, or untreated lymphoid malignancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive six weekly doses of subcutaneous daratumumab 1,800mg and hyaluronidase 30,000U
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measuring daratumumab levels and anti-RBC antibody levels
Long-term follow-up
Participants are monitored for time to next treatment and overall response rate
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor