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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00486421

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nonneoplastic Condition	Biological: Rituximab Drug: Prednisone	Early Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRED & RITUX	Biological: Rituximab 375mg/m2 IV weekly times 4 (days 1, 8, 15, 22) Other Names: Rituxan Drug: Prednisone 1mg/kg/d PO, taper to off by 8 weeks

Arm

Intervention/Treatment

Experimental: PRED & RITUX

Biological: Rituximab

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

Other Names:

Rituxan

Drug: Prednisone

1mg/kg/d PO, taper to off by 8 weeks

Outcome Measures

Primary Outcome Measures

Failure-free survival at 6 months [6 months]

Secondary Outcome Measures

Time to platelet recovery [1 year]
Duration of platelet recovery [1 year]
Effect of treatment on prevention of spontaneous bleeding events [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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