The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Sponsor
Peking University People's Hospital
Study ID
NCT03304288
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Low-dose rituximab was used in combination with ATRA or as the monotherapy
  • All-trans retinoic acid — DRUG
    ATRA was used in combination with low-dose rituximab

Study Details

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.

Key Dates

Start date
Oct 11, 2017
Status verified
Jan 2021
Primary completion
Jan 15, 2021
Completion
Feb 28, 2021

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: low-dose rituximab & ATRA
    rituximab 100mg once weekly for 6 weeks and oral all-trance retinoid acid 20mg/m\^2 qd for 12 weeks.
  • Active Comparator: low-dose rituximab
    rituximab 100mg once weekly for 6 weeks

Primary Outcome Measure

overall response [ Time Frame: From the start of study treatment (Day 1) up to the end of Year 1 ]

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