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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
DARA-AIHA Trial 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.Check my eligibility
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.See study design
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.
DARA-AIHA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with autoimmune hemolytic anemia.
Select...
I have been treated with steroids and rituximab before.
Select...
I am able to get out of my bed or chair and move around.
DARA-AIHA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine dose-limiting toxicities
Determine safety of treatment
Secondary outcome measures
Determine the overall response rate (ORR) of daratumumab in patients with relapsed/refractory AIHA
Determine the time to next treatment (TTNT)
Other outcome measures
Assess the change or elimination of anti-Red Blood Cell (RBC) antibody production
Trough Plasma Concentration (Cmin)
DARA-AIHA 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
524 Previous Clinical Trials
2,543,339 Total Patients Enrolled
Matthew Sullivan, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active Lupus affecting my organs and need treatment.I am taking steroids as part of my standard treatment.I am 18 years old or older.I do not have any serious uncontrolled illnesses, infections, or major heart problems.My blood cells continue to break down despite treatment or while on Prednisone.My liver is in its final stage of disease.I have active HIV, Hepatitis B, or C with a detectable viral load.I have been diagnosed with autoimmune hemolytic anemia.I have an active blood cancer other than the exceptions listed.I have previously been treated with daratumumab or other anti-CD38 therapies.I have been treated with steroids and rituximab before.I have a specific lung condition or kidney failure.I am able to get out of my bed or chair and move around.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment opportunities still available for the trial?
"Correct. The research posted on clinicaltrials.gov verifies that this medical trial is currently seeking volunteers, which was initially uploaded on March 21st 2022 and most recently altered in June 15th 2022. 10 participants are needed at one location for the experiment to proceed."
Answered by AI
What medical conditions have been found to benefit from Daratumumab / Hyaluronidase Injection?
"Daratumumab / Hyaluronidase Injection is a drug used to treat cell transplants, as well as furthering the effects of other medications through immunomodulation, increased absorption and dispersion in the body, and urography."
Answered by AI
To what capacity is this research recruiting participants?
"Affirmative. The information hosted on clinicaltrials.gov confirms that this research is searching for participants, which began recruitment on March 21st 2022 and was revised the 15th of June 2022. 10 individuals are desired from a single site."
Answered by AI
What risks are associated with administering Daratumumab / Hyaluronidase Injection to patients?
"As this is a Phase 1 clinical trial, and therefore limited evidence on safety and efficacy exists, the Daratumumab / Hyaluronidase Injection's score for safety was evaluated as a 1."
Answered by AI
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