A Phase 2 interventional study of Rituximab and All-trans retinoic acid in Immune Thrombocytopenia, sponsored by Peking University People's Hospital. Status unknown at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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.
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 relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option.
A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+ATRA and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Interim analysis was scheduled at 50% through recruitment. Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.
Exclusion Criteria:
rituximab 100mg once weekly for 6 weeks and oral all-trance retinoid acid 20mg/m\^2 qd for 12 weeks.
Drug: Rituximab · Drug: All-trans retinoic acid
rituximab 100mg once weekly for 6 weeks
Drug: Rituximab
Low-dose rituximab was used in combination with ATRA or as the monotherapy
ATRA was used in combination with low-dose rituximab
overall response
The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up. Interim analysis was scheduled at 50% through recruitment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
sustained response
The number of participants that can maintain the platelet count \> 30 x 109/L, an absence of bleeding events, and without requirement for any other ITP-specific treatment for 6 consecutive months after achievement of response. Interim analysis was scheduled at 50% through recruitment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
complete response
The number of participants (responders) with platelet count\>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up. Interim analysis was scheduled at 50% through recruitment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
time to response
Time to response was defined as the time from starting treatment to the time to achieve the response. Interim analysis was scheduled at 50% through recruitment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
duration of response
Duration of response was measured from the achievement of response to the loss of response. Interim analysis was scheduled at 50% through recruitment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
incidence of adverse events
All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Interim analysis was scheduled at 50% through recruitment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
Initial response
The number of patients who achieve response at 4 weeks following treatment
Time frame: From the start of study treatment (Day 1) up to the end of Week 4
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital