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

NCT01525836 | Completed Phase 3 DMC

• 1 other identifier: ITP-004
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Purpura; Idiopathic Thrombocytopenic Purpura

Keywords

Purpura; Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (4)

• Evaluation of platelet response (Complete Response)

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

  The time frame is up to 3 months per subject

• 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.

  The time frame is up to 3 months per subject

• 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.

  The time frame is up to 3 months per subject

• 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.

  The time frame is up to 3 months per subject

Secondary Outcomes (1)

• The number and frequency of therapy associated adverse events

  up to 3 months per subject

Study Arms (2)

combination treatment group

EXPERIMENTAL

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

Drug: rituximab; recombinant human thrombopoietin (rhTPO)

single treatment group

ACTIVE COMPARATOR

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

Drug: Rituximab

Interventions

rituximab; recombinant human thrombopoietin (rhTPO) DRUG

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)

Also known as: Recombinant Human Thrombopoietin, Recombinant Human TPO, rhTPO combine with Rituximab, Recombinant Human Thrombopoietin combine with Rituximab, Recombinant Human TPO combine with Rituximab

combination treatment group

Rituximab DRUG

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

single treatment group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
• 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.
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, China

Location

Related Publications (6)

• 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.

  PMID: 18510702 BACKGROUND

• Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

  PMID: 19846889 BACKGROUND

• Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

  PMID: 19005182 BACKGROUND

• Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.

  PMID: 12944568 BACKGROUND

• 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.

  PMID: 17077333 BACKGROUND

• Zhou H, Xu M, Qin P, Zhang HY, Yuan CL, Zhao HG, Cui ZG, Meng YS, Wang L, Zhou F, Wang X, Li DQ, Bi KH, Zhu CS, Guo CS, Chu XX, Wu QC, Liu XG, Dong XY, Li J, Peng J, Hou M. A multicenter randomized open-label study of rituximab plus rhTPO vs rituximab in corticosteroid-resistant or relapsed ITP. Blood. 2015 Mar 5;125(10):1541-7. doi: 10.1182/blood-2014-06-581868. Epub 2015 Jan 9.

  PMID: 25575541 DERIVED

MeSH Terms

Conditions

Purpura; Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab; Thrombopoietin

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Purpura, Thrombocytopenic; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Minf Hou, Dr.

  Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 20, 2016

Record last verified: 2013-05

Locations

CN (1)