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Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

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ClinicalTrials.gov Identifier: NCT03443570
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
The Affiliated Hospital of Qingdao University
Yantai Yuhuangding Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

Tracking Information
First Submitted Date  ICMJE February 18, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date February 23, 2018
Estimated Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2018)
Evaluation of platelet response(continuous response rate) [ Time Frame: up to 3 year per subject ]
Complete Response:a sustained (≥ 3 months) platelet count ≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2018)
therapy associated adverse events [ Time Frame: up to 3 year per subject ]
The number and frequency of therapy associated adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituximab Combining Bortezomib Versus Rituximab in Management of ITP
Official Title  ICMJE A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
Brief Summary 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 .
Detailed Description The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 100 ITP adult patients from 3 medical centers in China. One part of the participants are randomly selected to receive rituximab (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally) combining with bortezomib (given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally), the others are selected to receive rituximab alone (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally). Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to rituximab alone therapy for the treatment of adults with ITP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Immune Thrombocytopenia
  • Purpura, Thrombocytopenic, Idiopathic
Intervention  ICMJE
  • Drug: Rituximab
    given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
    Other Name: rituximab injection
  • Drug: Bortezomib
    given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally
    Other Name: velcade
Study Arms  ICMJE
  • Experimental: combination treatment group
    100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose
    Interventions:
    • Drug: Rituximab
    • Drug: Bortezomib
  • Active Comparator: control group
    100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose
    Intervention: Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Meet the diagnostic criteria for immune thrombocytopenia.
  2. Not previously used rituximab and bortezomid,untreated patients, may be male or female, between the ages of 18 ~ 80 years.
  3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  4. Eastern Cooperative Oncology Group(ECOG)performance status ≤ 2.

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  2. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  3. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
  4. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  5. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  6. Patients who are deemed unsuitable for the study by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ming Hou, Dr +86-531-82169114 ext 9879 houming@medmail.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443570
Other Study ID Numbers  ICMJE RTX and bortezomib in ITP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ming Hou, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE
  • The Affiliated Hospital of Qingdao University
  • Yantai Yuhuangding Hospital
Investigators  ICMJE
Principal Investigator: Ming Hou, Dr Shandong University
PRS Account Shandong University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP