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

NCT00486421 | Completed Early Phase 1 DMC

• 5 other identifiers: CDR0000529883P30CA015083MC04812071-04U2985s
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonneoplastic Condition

Keywords

idiopathic thrombocytopenic purpura

Outcome Measures

Primary Outcomes (1)

• Failure-free survival at 6 months

  6 months

Secondary Outcomes (3)

• Time to platelet recovery

  1 year

• Duration of platelet recovery

  1 year

• Effect of treatment on prevention of spontaneous bleeding events

  1 year

Study Arms (1)

PRED & RITUX

EXPERIMENTAL

Biological: Rituximab; Drug: Prednisone

Interventions

Rituximab BIOLOGICAL

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

Also known as: Rituxan

PRED & RITUX

Prednisone DRUG

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

PRED & RITUX

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab; Prednisone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ruben A. Mesa, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

US (1)