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

NCT01107951 | Completed Phase 2

• 1 other identifier: Rituximab in PTI 001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenic Purpura

Keywords

Rituximab; Dexamethasone; Low-dose; ITP

Outcome Measures

Primary Outcomes (1)

• Number of patients with sustained response after 6 months

  Number of patients with partial and complete response after 6 months.

  6 months

Secondary Outcomes (2)

• Number of patients with complete response at month 6

  month 6

• Bleeding

  month 6

Study Arms (1)

Rituximab -dexamethasone

OTHER

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

Drug: Rituximab and dexamethasone

Interventions

Rituximab and dexamethasone DRUG

Rituximab 100mg IV days 1,8,15,22. Dexamethasone 40mg PO days 1-4 (four days)

Also known as: Mabthera

Rituximab -dexamethasone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E Gonzalez UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (3)

• 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.

  PMID: 8177245 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

• 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.

  PMID: 18403395 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• David Gomez-Almaguer, MD

  Hospital Universitario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 21, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: January 1, 2013
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

ME (1)