Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Sponsor
Shandong University
Study ID
NCT03443570
Phase
PHASE3
Status
Unknown

Conditions

  • Immune Thrombocytopenia
  • Purpura, Thrombocytopenic, Idiopathic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
  • Bortezomib — DRUG
    given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally

Study Details

The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known hospitals in China. In order to report the efficacy and safety of rituximab combining with bortezomib for the treatment of adults with immune thrombocytopenia (ITP), compared to rituximab alone .

Key Dates

Start date
Mar 1, 2018
Status verified
Feb 2018
Primary completion
Mar 1, 2020
Completion
Mar 1, 2021

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: combination treatment group
    100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose
  • Active Comparator: control group
    100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose

Primary Outcome Measure

Evaluation of platelet response(continuous response rate) [ Time Frame: up to 3 year per subject ]

Central Contacts

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