Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP

NCT ID: NCT01107951

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult immune thrombocytopenic purpura.

Detailed Description

ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction and bleeding. Corticosteroids increase the platelet count in about 80 percent of patients.However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses. Rituximab 375 mg/m2 weekly for four weeks has significant activity in patients with immune thrombocytopenia. Furthermore, using lower dose rituximab the level of B-cell depletion and the response rates appear similar to those previously observed with standard dosages in a population of ITP.

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab (100mg IV days 1,8, 15 and 22) and high-dose dexamethasone (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic purpura.

A complete platelet response is defined as an increase in platelet counts to >150×109/L on two consecutive occasions. A partial response is defined as an increase in the platelet count to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response is considered from the day of the initial infusion to the first time of relapse (platelet count <30×109/L)or to time of analysis.

Conditions

Immune Thrombocytopenic Purpura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab -dexamethasone

only one arm receive four doses weekly rituximab and four dosis daily dexamethasona

Group Type: OTHER

Rituximab and dexamethasone

Intervention Type: DRUG

Rituximab 100mg IV days 1,8,15,22.

Dexamethasone 40mg PO days 1-4 (four days)

Interventions

Rituximab and dexamethasone

Rituximab 100mg IV days 1,8,15,22.

Dexamethasone 40mg PO days 1-4 (four days)

Intervention Type: DRUG

Other Intervention Names

Mabthera

Eligibility Criteria

Inclusion Criteria

• Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 30,000/mm3 on two occasions. Platelets >30000/mm3 with bleeding.
• Normal to increased numbers of megakaryocytes on bone marrow examination in patients ≥ 60 years
• Subject is ≥ 18 years
• Subject has signed and dated written informed consent.
• No sepsis or fever
• No active infection requiring therapy
• No active chronic viral infection
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion Criteria

• Performance status above or equal to 2.
• Previous treatment with rituximab
• Immunosuppressive treatment within the last month
• Previous splenectomy
• Presence of malignant haematological disease
• Connective tissue disease
• Autoimmune hemolytic anemia
• Pregnancy and lactation
• Not willing to participate in the study.
• Expected survival of < 2 years
• Known intolerance to murine antibodies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

David Gomez Almaguer

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Gomez-Almaguer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario

Locations

Hospital Universitario Dr. Jose E Gonzalez UANL

Monterrey, Nuevo León, Mexico

Countries

Mexico

References

Andersen JC. Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. N Engl J Med. 1994 Jun 2;330(22):1560-4. doi: 10.1056/NEJM199406023302203.

Reference Type: BACKGROUND

PMID: 8177245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12944568 (View on PubMed)

Zaja F, Battista ML, Pirrotta MT, Palmieri S, Montagna M, Vianelli N, Marin L, Cavallin M, Bocchia M, Defina M, Ippoliti M, Ferrara F, Patriarca F, Avanzini MA, Regazzi M, Baccarani M, Isola M, Soldano F, Fanin R. Lower dose rituximab is active in adults patients with idiopathic thrombocytopenic purpura. Haematologica. 2008 Jun;93(6):930-3. doi: 10.3324/haematol.12206. Epub 2008 Apr 9.

Reference Type: BACKGROUND

PMID: 18403395 (View on PubMed)

Other Identifiers

Rituximab in PTI 001

Identifier Type: -

Identifier Source: org_study_id