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Monoclonal Antibodies

Daratumumab for Hemolytic Anemia (DARA-AIHA Trial)

Phase 1
Waitlist Available
Led By Matthew Sullivan, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age must be 18 years or older
Patients must have confirmed autoimmune hemolytic anemia based on specific laboratory criteria
Must not have
Patients with a serious uncontrolled medical disorder, active infection, or significant cardiac disease
Patients with active Systemic Lupus Erythematosus with systemic organ involvement requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to give daratumumab to people who have anemia that does not respond to other treatments.

Who is the study for?
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.
What is being tested?
The study is testing the safety of Daratumumab/Hyaluronidase injection in patients with refractory Autoimmune Hemolytic Anemia. It's a single-arm trial where all participants receive the same treatment to see how well it works when other treatments haven't helped.
What are the potential side effects?
Potential side effects of Daratumumab can include infusion reactions (like fever or chills), fatigue, nausea, back pain, cough and shortness of breath. Since it affects the immune system's cells there might also be a higher risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with autoimmune hemolytic anemia.
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I have been treated with steroids and rituximab before.
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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious uncontrolled illnesses, infections, or major heart problems.
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I have active Lupus affecting my organs and need treatment.
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My liver is in its final stage of disease.
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I have active HIV, Hepatitis B, or C with a detectable viral load.
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I have previously been treated with daratumumab or other anti-CD38 therapies.
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I have a specific lung condition or kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine dose-limiting toxicities
Determine safety of treatment
Secondary study objectives
Determine the overall response rate (ORR) of daratumumab in patients with relapsed/refractory AIHA
Determine the time to next treatment (TTNT)
Other study objectives
Assess the change or elimination of anti-Red Blood Cell (RBC) antibody production
Trough Plasma Concentration (Cmin)

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: Arm 1Experimental Treatment1 Intervention
Six weekly doses of subcutaneous daratumumab 1,800mg and hyaluronidase 30,000U.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,539,714 Total Patients Enrolled
Matthew Sullivan, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05004259 — Phase 1
Hemolytic Anemia Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05004259 — Phase 1
Hemolytic Anemia Research Study Groups: Arm 1
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004259 — Phase 1
~0 spots leftby Dec 2024
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