The DART Study- Daratumumab Treatment in ITP

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    21
  • sponsor
    Ostfold Hospital Trust
Updated on 6 September 2021
platelet count
corticosteroids
rituximab
steroid therapy

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.

Description

Many patients with chronic ITP require repeated or continuous medications to maintain a safe platelet count.

B-cell depletion with rituximab in ITP induces the differentiation of short-lived auto-immune plasma cells into pathogenic long-lived plasma cells in the spleen that was not present before treatment. It has been reported that refractory ITP is related to the presence of long-lived plasma cells, which are resistant to steroids and immunosuppressants, including rituximab.

These findings lead to the hypothesis that therapy directed against plasma cells may help overcome treatment resistance. At least in a proportion of patients, treatment resistance is caused by CD20 negative long-lived plasma cells.

This study aims to investigate the efficacy, the optimal number of treatments, and safety of anti-CD38 antibody daratumumab steroid-refractory or steroid-dependent in ITP patients who fail to respond to at least one previous second-line therapy, including rituximab and/ or TPO agonist.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Inosine Triphosphate, Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic
Treatment Daratumumab Injection
Clinical Study IdentifierNCT04703621
SponsorOstfold Hospital Trust
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female aged 18 years
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
Signed and dated written informed consent
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

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
Pregnancy or lactation
Surgery planned within the 3 next months
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
Concomitant autoimmune hemolytic anemia
Known allergy and/or sensitivity or contraindication to daratumumab
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
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
Patient unable to attend all the visits planned for the trial
Known previous infection or seropositivity for Hepatitis B
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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