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

NCT ID: NCT00486421

Last Updated: 2014-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-11-30

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.

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.

Conditions

Nonneoplastic Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRED & RITUX

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: BIOLOGICAL

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

Prednisone

Intervention Type: DRUG

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

Interventions

Rituximab

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

Intervention Type: BIOLOGICAL

Prednisone

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

Intervention Type: DRUG

Other Intervention Names

Rituxan

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruben A. Mesa, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

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MC0481

Identifier Type: OTHER

Identifier Source: secondary_id

2071-04

Identifier Type: OTHER

Identifier Source: secondary_id

U2985s

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000529883

Identifier Type: -

Identifier Source: org_study_id