Phase II Trial of Romiplostim With Danazol in Patients With Eltrombopag-resistant Immune Thrombocytopenia
- Registration Number
- NCT04289207
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
In this study, we tried to demonstrate clinical benefit of additive danazol to romiplostim therapy in patients with eltrombopag-resistant immune thrombocytopenia
- Detailed Description
The patients with eltrombopag-resistant immune thrombocytopenia are treated with romiplostim and danazol. The efficacy and toxicity of treatment will be evaluated.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- aged over 18 years
- diagnosed with immune thrombocytopenia (bone marrow examination is not necessary)
- failed to achieve platelet count over 50X10^9/L with eltrombopag
- ECOG performance status 0,1,2
- available to obtain informed consent
Exclusion Criteria
- Hepatitis B or C carriers
- HIV positive patients
- diagnosed with systemic lupus erythematosus or other autoimmune disorders
- unable to intake orally or absorb through gastrointestinal tract
- pregnant or breast-feeding
- diagnosed with uncontrolled seizure or other neuropsychiatric disorders
- diagnosed with clinically significant cardiovascular events within 6 months or dyspnea on exertion evaluated to New York Heart Association Functional Classification III or IV
- diagnosed with clinically significant cerebrovascular disorders
- previously diagnosed or treated with thromboembolism
- current treating malignant diseases
- currently accompanied by uncontrolled infection or active bleeding
- with blood test results as follows; total bilirubin > 2xUNL(upper normal limit), AST/ALT > 1.5xUNL, creatinine > 1.5xUNL, glomerular filtration rate < 30ml/min/1.73m^2
- registered to other clinical trials for treatment of immune thrombocytopenia
- judged to be inappropriate for clinical trial by doctor in charge
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Romiplostim and danazol Romiplostim and danazol Treatment group (romiplostim and danazol)
- Primary Outcome Measures
Name Time Method Response rate week 8 proportion of patients with platelet count over 50x10\^9/L
- Secondary Outcome Measures
Name Time Method Effects on quality of life week 24 changes in EORTC QLQ-C30 scores
Time to best response week 24 time interval between initiation of treatment and best response
Response duration week 24 period of time with platelet count over 50x10\^9/L