Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP
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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. |
- 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.
- 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 |
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| Mexico | |
| Hospital Universitario Dr. Jose E Gonzalez UANL | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| 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 May 23, 2013