The Study of Different Dose Rituximab in the Treatment of ITP

Immune Thrombocytopenia Clinical Trial

Official title:

The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258866
• Other study ID #: RTX 4v1 in ITP
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2017
• Last updated: August 22, 2017
• Start date: January 1, 2010
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2017
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Description:

62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. Male or female, between the ages of 10 ~ 70 years.

3. Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective

4. To show a platelet count < 30×10^9/L, or with bleeding manifestations.

5. Eastern Cooperative Oncology Group(ECOG)performance status = 2

Exclusion Criteria:

1. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

2. 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)

3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

4. 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.

5. Patients who are deemed unsuitable for the study by the investigator.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rituximab
given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
• Rituximab
given with a single dose of 375mg/m2

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Auger S, Duny Y, Rossi JF, Quittet P. Rituximab before splenectomy in adults with primary idiopathic thrombocytopenic purpura: a meta-analysis. Br J Haematol. 2012 Aug;158(3):386-98. doi: 10.1111/j.1365-2141.2012.09169.x. Epub 2012 May 22. — View Citation

Brah S, Chiche L, Fanciullino R, Bornet C, Mancini J, Schleinitz N, Jean R, Kaplanski G, Harlé JR, Durand JM. Efficacy of rituximab in immune thrombocytopenic purpura: a retrospective survey. Ann Hematol. 2012 Feb;91(2):279-85. doi: 10.1007/s00277-011-128 — View Citation

Garcia-Suarez J, Prieto A, Reyes E, Manzano L, Merino JL, Alvarez-Mon M. The clinical outcome of autoimmune thrombocytopenic purpura patients is related to their T cell immunodeficiency. Br J Haematol. 1993 Jul;84(3):464-70. — View Citation

Grace RF, Bennett CM, Ritchey AK, Jeng M, Thornburg CD, Lambert MP, Neier M, Recht M, Kumar M, Blanchette V, Klaassen RJ, Buchanan GR, Kurth MH, Nugent DJ, Thompson AA, Stine K, Kalish LA, Neufeld EJ. Response to steroids predicts response to rituximab in — View Citation

Gudbrandsdottir S, Birgens HS, Frederiksen H, Jensen BA, Jensen MK, Kjeldsen L, Klausen TW, Larsen H, Mourits-Andersen HT, Nielsen CH, Nielsen OJ, Plesner T, Pulczynski S, Rasmussen IH, Rønnov-Jessen D, Hasselbalch HC. Rituximab and dexamethasone vs dexam — View Citation

Reboursiere E, Fouques H, Maigne G, Johnson H, Chantepie S, Gac AC, Reman O, Macro M, Benabed K, Troussard X, Damaj G, Cheze S. Rituximab salvage therapy in adults with immune thrombocytopenia: retrospective study on efficacy and safety profiles. Int J He — View Citation

Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. — View Citation

Zaja F, Volpetti S, Chiozzotto M, Puglisi S, Isola M, Buttignol S, Fanin R. Long-term follow-up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia. Am J Hematol. 2012 Sep;87(9):886-9. doi: 10.1002/ajh.23272. Epub 2012 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of platelet response(continuous response rate)	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.	up to 1 year per subject
Secondary	therapy associated adverse events	The number and frequency of therapy associated adverse events	up to 1 year per subject