Treatment of ITP With Rituximab and / or Accutane

Immune Thrombocytopenia Clinical Trial

Official title:

Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02757196
• Other study ID #: ITP Treatment--100
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 17, 2016
• Last updated: May 11, 2016
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Peking University People's Hospital
• Contact: Xiao-Hui Zhang, Doctor
• Phone: 861088324577
• Email: zhangxh100[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China

Description:

This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China. The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed

2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation

3. Subject is = 18 years and =80years

4. Subject has signed and dated written informed consent.

5. Fertile patients must use effective contraception during treatment and observational period

6. Negative pregnancy test

Exclusion Criteria:

1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL

2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal

3. Have a New York Heart Classification III or IV heart disease

4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures

5. Have active hepatitis B or hepatitis C infection

6. Have a HIV infection

7. Have active infection requiring antibiotic therapy within 7 days prior to study entry

8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug

9. Previous treatment with rituximab

10. Previous splenectomy

11. Had previous or concomitant malignant disease

12. Not willing to participate in the study.

13. Expected survival of < 2 years

14. Intolerant to murine antibodies

15. Immunosuppressive treatment within the last month

16. Connective tissue disease

17. Autoimmune hemolytic anemia

18. Patients currently involved in another clinical trial with evaluation of drug treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Rituximab plus methylprednisolone
rituximab (1000mg IV day1, week 3, week 17 , and week 19)
• methylprednisolone
1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse free survival	Relapse was defined as a drop in platelet count to <30 ×109/L following an initial best response (partial or complete response).	From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year	No
Secondary	Cumulative response rate	platelet count = 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.	1 year	No
Secondary	Cumulative complete response rate	platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding	1 year	No
Secondary	Cumulative relapse rate	Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)	1 year	No
Secondary	adverse event/serious adverse event and cumulative rate of bleeding events	adverse event/serious adverse event associated with study drugs and bleeding events	1 year	Yes