Daratumumab / Hyaluronidase Injection for Hemolytic Anemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dartmouth-Hitchcock Medical Center, Lebanon, NH
Hemolytic Anemia+3 More
Daratumumab / Hyaluronidase Injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia

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Eligible Conditions

  • Hemolytic Anemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hemolytic Anemia

Study Objectives

This trial is evaluating whether Daratumumab / Hyaluronidase Injection will improve 2 primary outcomes, 2 secondary outcomes, and 2 other outcomes in patients with Hemolytic Anemia. Measurement will happen over the course of Up to 6 weeks.

Day 28
Trough Plasma Concentration (Cmin)
Year 1
Determine the time to next treatment (TTNT)
Up to 10 weeks
Determine safety of treatment
Up to 18 weeks
Determine the overall response rate (ORR) of daratumumab in patients with relapsed/refractory AIHA
Up to 6 weeks
Assess the change or elimination of anti-Red Blood Cell (RBC) antibody production
Determine dose-limiting toxicities

Trial Safety

Safety Progress

1 of 3

Other trials for Hemolytic Anemia

Trial Design

1 Treatment Group

Arm 1
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Daratumumab / Hyaluronidase Injection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Arm 1
Drug
Six weekly doses of subcutaneous daratumumab 1,800mg and hyaluronidase 30,000U.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Who is running the study

Principal Investigator
M. R. S.
Prof. Matthew R. Sullivan, Assistant Professor of Medicine, Geisel School of Medicine, Dartmouth
Dartmouth-Hitchcock Medical Center

Closest Location

Dartmouth-Hitchcock Medical Center - Lebanon, NH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hemolytic Anemia or one of the other 3 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What are common treatments for hemolytic anemia?

"Hemolytic anemia is commonly treated with intravenous, intramuscular, subcutaneous, or oral blood transfusions. Treatment of hemoglobinuria and transfusion reactions can be challenging; for example, the use of immunoglobulin treatments may be life-saving. Further research to identify and develop treatment methods that target all three steps of hemolysis pathogenesis is needed." - Anonymous Online Contributor

Unverified Answer

What is hemolytic anemia?

"A hemolysis is blood loss that starts in a blood vessel, and that causes damage to the red blood cells. Hemolytic anemia can be congenital, acquired, or traumatic. Congenital hemolytic anemia occurs only when a person is born with a genetic predisposition to it such as sickle cell aplasia. The most common cause of acquired hemolytic anemia is medication. Hemolytic anemia is most commonly defined as a sudden decrease in red blood cell production caused by damage to the bone marrow." - Anonymous Online Contributor

Unverified Answer

How many people get hemolytic anemia a year in the United States?

"The annual number of people in the United States who develop hemorrhagic symptoms from an erythrocytic hemolytic process is estimated to be 1.4 per 10,000 population per year. This incidence is about 2-fold higher than that seen in Europe and North America." - Anonymous Online Contributor

Unverified Answer

Can hemolytic anemia be cured?

"The majority of patients with a history of hemolytic anemia of long duration were cured of Hb<5 g/dL. The success rate of the procedure in treating Hb<5 g/dL is lower when it is performed more advanced in life expectancy." - Anonymous Online Contributor

Unverified Answer

What are the signs of hemolytic anemia?

"Signs of anemia include pallor, tachypnea, dyspnea, and jaundice. These signs are also found in patients without hemolytic anemia. Hemolytic anemia can be confirmed by a complete peripheral blood smear, though a bone marrow examination can also be done.\n" - Anonymous Online Contributor

Unverified Answer

What causes hemolytic anemia?

"Most cases of hemolytic anemia are of low or intermediate risk, but some are of high risk and may require prompt consultation with a hematologist. The diagnosis and management of anemia must be based on the underlying mechanism of the disease." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hemolytic anemia?

"[Hemolytic anemia may result from a variety of causes (see Causes of anemia). Nevertheless, in more than 95% of cases an identifiable cause is identified, which can be managed to prevent further anemia manifestations and/or morbidity and mortality. For the next decade, transfusion of blood components will depend on the anemia cause, as it has been with all previous forms of transfusion (blood components were introduced into the use of anemia management in 1952 in the United States). Transfusion therapy is based on the "RBC" or red blood cell, which cannot be replaced by blood components, as in the case of hemolysis (loses its ability to donate blood)." - Anonymous Online Contributor

Unverified Answer

Is daratumumab / hyaluronidase injection typically used in combination with any other treatments?

"Dara-Mab / HA is generally associated with the possibility of a life-threatening anaphylactic reaction. Such a reaction occurs if daratumumab is used in combination with a broad range of agents." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in daratumumab / hyaluronidase injection for therapeutic use?

"DMT seems to be useful to reduce IAEs in refractory cases of IBD. However, the mechanism for the effect of DMT in inducing IAEs is unknown. One possible explanation that could be given is that DMT may induce IAEs primarily because of hyaluronidase effect and that the effects should not be considered the primary effect of DMT. Since IAEs were reduced in some cases in this group, DMT may be a potential treatment for other autoimmune diseases (e.g. rheumatoid arthritis)." - Anonymous Online Contributor

Unverified Answer

What does daratumumab / hyaluronidase injection usually treat?

"We suggest that daratumumab should not be prescribed intravenously, but should be administered subcutaneously; however, since the effectiveness of this method is not clear, we suggest that it should be prescribed for a limited number of patients. Further development of treatments for rIT is necessary." - Anonymous Online Contributor

Unverified Answer

How serious can hemolytic anemia be?

"Even in the absence of acute inflammation of the perisinus sulcus, hemolysis can be severe and prolonged. Patients should be monitored carefully whilst hospitalized, on dialysis and throughout their recovery period after the operation." - Anonymous Online Contributor

Unverified Answer

Is daratumumab / hyaluronidase injection safe for people?

"Despite the small number of people included and the short duration of follow-up it seems that the daratumumab/hyaluronidase injection would not have a profound effect on hematologic parameters during the follow-up period. So it is safe to administer this therapy for 5 months in healthy adults." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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