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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01107951
First received: April 9, 2010
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Immune Thrombocytopenic Purpura
Drug: Rituximab and dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for Adult Patients With Immune Thrombocytopenic Purpura.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Number of patients with sustained response after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients with partial and complete response after 6 months.


Secondary Outcome Measures:
  • Number of patients with complete response at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Number of patients with platelet count at least 150x109/L, 6 months after therapy

  • Bleeding [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
    Number of patients with bleeding complication after therapy


Enrollment: 21
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rituximab -dexamethasone
only one arm receive four doses weekly rituximab and four dosis daily dexamethasona
Drug: Rituximab and dexamethasone

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

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

Other Name: Mabthera

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107951

Locations
Mexico
Hospital Universitario Dr. Jose E Gonzalez UANL
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: David Gomez-Almaguer, MD Hospital Universitario
  More Information

Publications:
Responsible Party: David Gomez Almaguer, Medical doctor, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01107951     History of Changes
Other Study ID Numbers: Rituximab in PTI 001
Study First Received: April 9, 2010
Last Updated: March 21, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Rituximab
Dexamethasone
Low-dose
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Rituximab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 20, 2014