The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
1 other identifier
interventional
168
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2017
CompletedFirst Posted
Study publicly available on registry
October 9, 2017
CompletedStudy Start
First participant enrolled
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedJanuary 20, 2021
January 1, 2021
3.3 years
October 3, 2017
January 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
complete response
From the start of study treatment (Day 1) up to the end of Year 1
time to response
From the start of study treatment (Day 1) up to the end of Year 1
duration of response
From the start of study treatment (Day 1) up to the end of Year 1
incidence of adverse events
From the start of study treatment (Day 1) up to the end of Year 1
Initial response
From the start of study treatment (Day 1) up to the end of Week 4
Study Arms (2)
low-dose rituximab & ATRA
EXPERIMENTALrituximab 100mg once weekly for 6 weeks and oral all-trance retinoid acid 20mg/m\^2 qd for 12 weeks.
low-dose rituximab
ACTIVE COMPARATORrituximab 100mg once weekly for 6 weeks
Interventions
Low-dose rituximab was used in combination with ATRA or as the monotherapy
ATRA was used in combination with low-dose rituximab
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University People's Hospitallead
- Beijing Hospitalcollaborator
- Navy General Hospital, Beijingcollaborator
- Beijing Tongren Hospitalcollaborator
Study Sites (4)
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Navy General Hospital
Beijing, Beijing Municipality, 100048, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Related Publications (1)
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.
PMID: 34665865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao-hui Zhang, Professor
Peking University Insititute of Hematology, Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 3, 2017
First Posted
October 9, 2017
Study Start
October 11, 2017
Primary Completion
January 15, 2021
Study Completion
February 28, 2021
Last Updated
January 20, 2021
Record last verified: 2021-01