The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hem… (NCT05004259) | Clinical Trial Compass
CompletedPhase 1
The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia
United States2 participantsStarted 2022-03-21
Plain-language summary
A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients must have confirmed autoimmune hemolytic anemia, based on a Hemoglobin \<10 g/dL, a positive Direct Antiglobulin Test, elevated LDH, and elevated Reticulocyte count, low Haptoglobin test.
* Patients must have been previously treated with both a course of steroids starting at a dose of at least 1mg/kg of Prednisone (or steroid equivalent) and at least 100mg of rituximab previously. They must show signs of ongoing hemolysis (as above) either 1) recurring after previous treatment, 2) or while on a Prednisone dose (or equivalent) of 10mg daily or greater.
* Age ≥18 years
* Patients are allowed to be on steroids, as per standard of care. The dosing regimens may include up to 1mg/kg of Prednisone followed by a Prednisone taper, or a regimen of 40mg of Dexamathasone for 4 days. (See Section 6.13 for recommended steroid taper.)
* All patients must give informed consent indicating they are aware of the investigational nature of this treatment, as well as the study protocols and requirements.
* Patients with Evan's syndrome are permissible
* Patients must have performance status of ECOG 0-2
Exclusion Criteria:
* Patients with active HIV, Hepatitis B, Hepatitis C. We define active as having a detectable viral load. Patients with a prior exposure or well controlled disease while on treatment will be permitted. More information regarding management of these infections can be found in the footnote of the schema in Section 6.1.
* Patients with active Sy…