The DART Study- Daratumumab Treatment in ITP

• Status: Recruiting
• Trial end date: 2024-12-20
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter clinical, open-label total dose-escalating phase II study with safety run-in to explore the clinical activity, total dosage, and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or TPO-RA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ostfold Hospital Trust
• Collaborators: Haukeland University Hospital; Henri Mondor University Hospital; Odense University Hospital; Oslo University Hospital; University Hospital, Akershus
• Treatments: Daratumumab

Criteria

Inclusion Criteria:

1. Male or female aged ≥18 years.

2. Primary ITP with a platelet count of ≤30 X 109/L measured within 2 weeks prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab >12 weeks ago and/or TPO-RA. For the safety run-in phase, a platelet count of 15-30 X 109/L will be required

3. Signed and dated written informed consent.

4. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 24 weeks following the administration of first daratumumab injection. A man who has not had a vasectomy and who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control e.g. condom with spermicidal foam/film/gel/cream/ suppository, and all men must also not donate sperm during the study and for 3 month following discontinuation of Daratumumab (for details see appendix VII)

Exclusion Criteria:

1. Patients with active bleeding during the last 7 days prior to inclusion. Active bleeding is defined as any clinically overt hemorrhage (including radiologically diagnosed bleeding) with ongoing hemoglobin fall or bleeding requiring immediate intervention

2. Pregnancy or lactation

3. Surgery planned within the 3 next months

4. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, drug induced or ITP secondary to autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, common variable immune deficiency, human immunodeficiency virus, or hepatitis C

5. Concomitant autoimmune hemolytic anemia

6. Known allergy and/or sensitivity or contraindication to daratumumab

7. Active malignancy with the exception of basal and squamous carcinoma of the skin, in situ cervical cancer. Low grade (Gleason 3+3 or less) prostate cancer or in situ breast carcinoma if surgically treated.

8. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.

9. Patient unable to attend all the visits planned for the trial

10. Known previous infection or seropositivity for Hepatitis B