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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 October 2020
Main ID:  EUCTR2019-004683-22-NO
Date of registration: 29/04/2020
Prospective Registration: Yes
Primary sponsor: Ostfold Hospital Trust
Public title: Daratumumab as a treatment for adult immune thrombocytopenia
Scientific title: Daratumumab as a treatment for adult immune thrombocytopenia - The DART-study
Date of first enrolment: 16/10/2020
Target sample size: 20
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004683-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: First 10 patients receive 1800mg once a week x 8 and 10 patients receive 1800 mg x 10 times
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Norway
Contacts
Name: Sykehuset Østfold   
Address:  Kalnesveien 300 1714 Grålum Norway
Telephone: +4769860000
Email: postmottak@so-hf.no
Affiliation:  Ostfold Hospital Trust
Name: Sykehuset Østfold   
Address:  Kalnesveien 300 1714 Grålum Norway
Telephone: +4769860000
Email: postmottak@so-hf.no
Affiliation:  Ostfold Hospital Trust
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female aged =18 years.
2. Primary ITP with a platelet count of =30 X 109/L measured within 4 weeks prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPO-RA.
3. Signed and dated written informed consent.
4. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 3 months following the last administration of daratumumab

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1. Patients with active bleeding
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. Patients in a severely immune compromised state
8. Active malignancy
9. 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.
10. Patient unable to attend all the visits planned for the trial
11. Known previous infection or seropositivity for Hepatitis B.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Immune thrombocytopenia
MedDRA version: 23.0 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Intervention(s)

Product Name: daratumumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DARATUMUMAB
CAS Number: 945721-28-8
Current Sponsor code: JnJ 54767414
Other descriptive name: HUMAX-CD38
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)
Main Objective: 1- to determine the efficacy of treatment with daratumumab in ITP
2- to characterize the safety of daratumumab in ITP
3- to identify the optimal total dose of daratumumab (duration of treatment) to use in future studies
Primary end point(s): The main efficacy end point will be measured by the proportion of patients in each cohort who achieve platelet count >50 X 109/L in 2 measurements within week 12 in cohort 1 and within week 16 in cohort 2, after first daratumumab injection, without having received rescue therapy or having had dose increment of (TPO-RA or corticosteroids) during the last 4 weeks
Secondary Objective: 1. to explore anti-platelet antibody positivity in serum before and after treatment with daratumumab
2. to explore the immunophenotypic changes in peripheral blood and bone marrow mononuclear cells, before and after exposure to daratumumab
3. to determine HRQoL and level of fatigue before and after treatment daratumumab and to compare HRQoL in responders vs non-responders.
Timepoint(s) of evaluation of this end point: 12 or 16 weeks
Secondary Outcome(s)
Secondary end point(s): a. The duration of response defined as the cumulative number of weeks with platelet count >50 X 109/L between end of treatment and end of the study or week 24 for last patient, without having received rescue therapy or having had dose increment of corticosteroids in the 4 weeks prior to the first platelet counts >50 X 109/L
b. Time of first platelet count >50 X 109/L after first daratumumab administration
c. Proportion of patients in each cohort who achieve platelet count >100 X 109/L during week 12 in cohort 1 and week 16 in cohort 2, after first daratumumab injection without having received any rescue therapy or having had dose increment of (TPO-RA or corticosteroids) during the last 4 weeks prior to week 12 or 16 in the two respective cohorts.
d. Bleeding episodes during observation time
e. Time to treatment failure in each cohort, where treatment failure is defined as first platelet count <30 X 109/L, administration of any platelet elevating therapy after achieving response.
Timepoint(s) of evaluation of this end point: 24 weeks or end of study
Secondary ID(s)
RGCH005
Source(s) of Monetary Support
Ostfold Hospital Trust
Regional Health Authority South East
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 06/03/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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