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rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP

Primary Purpose

Purpura, Idiopathic Thrombocytopenic Purpura

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

rituximab; recombinant human thrombopoietin (rhTPO)

Rituximab

About this trial

This is an interventional treatment trial for Purpura focused on measuring Purpura, Idiopathic Thrombocytopenic Purpura

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
Willing and able to sign written informed consent

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

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

6.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.

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

Sites / Locations

Qilu Hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combination treatment group

single treatment group

Arm Description

120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.

120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.

Outcomes

Primary Outcome Measures

Evaluation of platelet response (Complete Response)

CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L

Evaluation of platelet response (Response)

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.

Evaluation of platelet response (No Response)

NR.No response (NR) was defined as 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.

Evaluation of platelet response (relapses)

A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Secondary Outcome Measures

The number and frequency of therapy associated adverse events

Full Information

NCT ID

NCT01525836

First Posted

January 31, 2012

Last Updated

April 18, 2016

Sponsor

Shandong University

Collaborators

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital, Shenzhen Second People's Hospital, First Hospital of China Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01525836

Brief Title

rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP

Official Title

Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.

Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days,following with a flexible dosage depending on platelet count until the 29th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg weekly, i.e. Day 1, 8, 15, 22). 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 conventional rituximab therapy for the treatment of adults with refractory ITP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Purpura, Idiopathic Thrombocytopenic Purpura

Keywords

Purpura, Idiopathic Thrombocytopenic Purpura

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

combination treatment group

Arm Type

Experimental

Arm Description

120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.

Arm Title

single treatment group

Arm Type

Active Comparator

Arm Description

120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.

Intervention Type

Drug

Intervention Name(s)

rituximab; recombinant human thrombopoietin (rhTPO)

Other Intervention Name(s)

Recombinant Human Thrombopoietin, Recombinant Human TPO, rhTPO combine with Rituximab, Recombinant Human Thrombopoietin combine with Rituximab, Recombinant Human TPO combine with Rituximab

Intervention Description

patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 29th day)

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)

Primary Outcome Measure Information:

Title

Evaluation of platelet response (Complete Response)

Description

CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L

Time Frame

The time frame is up to 3 months per subject

Title

Evaluation of platelet response (Response)

Description

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.

Time Frame

The time frame is up to 3 months per subject

Title

Evaluation of platelet response (No Response)

Description

Time Frame

The time frame is up to 3 months per subject

Title

Evaluation of platelet response (relapses)

Description

A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Time Frame

The time frame is up to 3 months per subject

Secondary Outcome Measure Information:

Title

The number and frequency of therapy associated adverse events

Time Frame

up to 3 months per subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years. To show a platelet count < 30×10^9/L, and with bleeding manifestations. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2. Willing and able to sign written informed consent Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6.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. 7.Patients who are deemed unsuitable for the study by the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minf Hou, Dr.

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu Hospital, Shandong University

City

Jinan

State/Province

Shandong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

18510702

Citation

Medeot M, Zaja F, Vianelli N, Battista M, Baccarani M, Patriarca F, Soldano F, Isola M, De Luca S, Fanin R. Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results. Eur J Haematol. 2008 Sep;81(3):165-9. doi: 10.1111/j.1600-0609.2008.01100.x. Epub 2008 May 27.

Results Reference

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PubMed Identifier

19846889

Citation

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Results Reference

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PubMed Identifier

19005182

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. doi: 10.1182/blood-2005-12-015222. Epub 2006 Oct 31.

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Citation

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Results Reference

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rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP

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