Status:
UNKNOWN
The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beijing Hospital
Navy General Hospital, Beijing
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.
Detailed Description
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relaps...
Eligibility Criteria
Inclusion
- ITP confirmed by excluding other supervened causes of thrombocytopenia;
- Platelet count of less than 30×10\^9/L at enrollment;
- Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
- ECOG\<2.
Exclusion
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- Congestive heart failure
- Severe arrhythmia
- Nursing or pregnant women
- Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria
- Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
- Active or previous malignancy
- Patients with other diseases were undergoing treatment with immunosuppressants
- Patients with ITP had received rituximab
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03304288
Start Date
October 11 2017
End Date
February 28 2021
Last Update
January 20 2021
Active Locations (4)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Navy General Hospital
Beijing, Beijing Municipality, China, 100048
3
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
4
Beijing Tongren Hospital
Beijing, Beijing Municipality, China