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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Navy General Hospital, Beijing | OTHER |
| Beijing Tongren Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose rituximab & ATRA | Experimental | rituximab 100mg once weekly for 6 weeks and oral all-trance retinoid acid 20mg/m^2 qd for 12 weeks. |
|
| low-dose rituximab | Active Comparator | rituximab 100mg once weekly for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Low-dose rituximab was used in combination with ATRA or as the monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From the start of study treatment (Day 1) up to the end of Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of study treatment (Day 1) up to the end of Year 1 |
| time to response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-hui Zhang, Professor | Peking University Insititute of Hematology, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34665865 | Derived | Wu YJ, Liu H, Zeng QZ, Liu Y, Wang JW, Wang WS, Jia-Feng, Zhou HB, Huang QS, He Y, Fu HX, Zhu XL, Jiang Q, Jiang H, Chang YJ, Xu LP, Huang XJ, Zhang XH. All-trans retinoic acid plus low-dose rituximab vs low-dose rituximab in corticosteroid-resistant or relapsed ITP. Blood. 2022 Jan 20;139(3):333-342. doi: 10.1182/blood.2021013393. |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| All-trans retinoic acid | Drug | ATRA was used in combination with low-dose rituximab |
|
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. |
| 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. | 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. | 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 | From the start of study treatment (Day 1) up to the end of Week 4 |
| Navy General Hospital |
| Beijing |
| Beijing Municipality |
| 100048 |
| China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| Beijing Tongren Hospital | Beijing | Beijing Municipality | China |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |