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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00486421
First received: June 13, 2007
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Nonneoplastic Condition
Biological: Rituximab
Drug: Prednisone
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Failure-free survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to platelet recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Duration of platelet recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Effect of treatment on prevention of spontaneous bleeding events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: January 2007
Study Completion Date: November 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRED & RITUX Biological: Rituximab
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
Other Name: Rituxan
Drug: Prednisone
1mg/kg/d PO, taper to off by 8 weeks

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486421

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Ruben A. Mesa, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00486421     History of Changes
Other Study ID Numbers: CDR0000529883, P30CA015083, MC0481, 2071-04, U2985s
Study First Received: June 13, 2007
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
idiopathic thrombocytopenic purpura

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies
Prednisone
Rituximab
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014