Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura

Nonneoplastic Condition Clinical Trial

Official title:

A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486421
• Other study ID #: CDR0000529883
• Secondary ID: P30CA015083MC048
• Status: Completed
• Phase: Phase 0
• First received: June 13, 2007
• Last updated: October 15, 2014
• Start date: January 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Rituximab and prednisone may increase the number of platelets in patients with immune thrombocytopenic purpura.

PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with prednisone works as first-line therapy in treating patients with immune thrombocytopenic purpura.

Description:

OBJECTIVES:

Primary

• Determine the efficacy of rituximab, when administered with standard prednisone treatment, in maintaining a platelet count ≥ 50,000/mm³ at 6 months without further therapies (e.g., splenectomy or other salvage therapies) in patients with immune thrombocytopenic purpura.

• Determine the safety of this regimen in these patients.

Secondary

• Determine the time to platelet recovery in patients treated with this regimen.

• Determine the duration of platelet recovery in patients treated with this regimen.

• Assess efficacy of this regimen in preventing spontaneous bleeding events in these patients.

• Determine the response in patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive rituximab IV on days 1, 8, 15, and 22 and oral prednisone once daily on days 1-14 followed by a taper to day 56. Treatment is administered in the absence of disease relapse or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of immune thrombocytopenic purpura (ITP)

• Diagnosis must be made according to American Society of Hematology diagnostic guidelines by a member of Mayo Rochester's Division of Hematology/Oncology within the past year

• ITP must be confirmed by bone marrow aspiration and biopsy in all patients = 60 years of age*

• Bone marrow studies performed outside Mayo must be reviewed by a Mayo hematopathologist to confirm diagnosis and exclude evidence of other hematologic disorders NOTE: *Bone marrow evaluation is discretionary for all other patients

• Requires treatment, as defined by 1 of the following parameters:

• Platelet count = 30,000/mm³

• Platelet count = 50,000/mm³ with episodic bleeding (i.e., spontaneous or with minimal trauma) requiring treatment

• No concurrent diagnosis of a condition known to cause secondary immune (or nonimmune) thrombocytopenia, including, but not limited to, any of the following:

• Rheumatological conditions, such as lupus, rheumatoid arthritis, scleroderma, or mixed connective tissue disorder

• Patients with positive serologies and no concurrent, clinically evident condition are eligible

• HIV positive or AIDS

• Non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic lymphoma, multiple myeloma, or other malignant hematological conditions

• Clinically evident antiphospholipid antibody syndrome* or heparin-induced thrombocytopenia

• Clinically overt liver disease, hepatitis B surface antigen positive, hepatitis C serology positive, or evidence of a microangiopathic hemolytic anemia, such as disseminated intravascular coagulation, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura, or preeclampsia NOTE: *Positive laboratory tests without the defined clinical criteria for a diagnosis of antiphospholipid antibody syndrome is allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Creatinine = 2 times upper limit of normal (ULN)

• Direct bilirubin = 1.5 times ULN

• Total bilirubin = 1.5 times ULN

• AST = 2.5 times ULN

• Hemoglobin = 10 g/dL

• WBC = 3,000/mm³

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No hypersensitivity to murine or chimeric proteins

• No other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications

• Able to take a proton-pump inhibitor while on corticosteroids

• No unresolved or incompletely treated infection within the past 14 days

PRIOR CONCURRENT THERAPY:

• No prior corticosteroid therapy since the diagnosis of ITP

• Corticosteroid therapy is allowed for up to 14 days prior to study entry, once the baseline CBC has been established

• No prior rituximab

• No other concurrent therapy for ITP, including androgens, IV immunoglobulins, RH_o (D) immune globulin, cyclosporine, or azathioprine sodium

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nonneoplastic Condition
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Biological:
• Rituximab
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)

Drug:
• Prednisone
1mg/kg/d PO, taper to off by 8 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival at 6 months		6 months	No
Secondary	Time to platelet recovery		1 year	No
Secondary	Duration of platelet recovery		1 year	No
Secondary	Effect of treatment on prevention of spontaneous bleeding events		1 year	No