Status:
WITHDRAWN
A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Idiopathic Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone...
Detailed Description
Primary Objectives 1. Efficacy: The primary objective (primary endpoint) is to determine the rate of response (partial or complete response) at week 16 (± 2) post-treatment in both pilot arms: the hi...
Eligibility Criteria
Inclusion
- Patients will be eligible to participate in the study if they:
- Have chronic ITP19 (\> 6 months duration).
- Have received Rituximab a minimum of 3 months prior to entry.
- Have received no more than 2 courses of Rituximab at standard dose separated by a minimum of 12 weeks.
- Have not achieved a durable response to Rituximab, with platelet counts \< 30,000/ml when not supported by other treatment.
- Have a platelet count of \< 30,000/ul on two separate occasions 1-2 weeks apart within the past month prior to the inclusion.
- Are age ≥ 12 years old.
- Had a splenectomy at least 60 days prior to study entry, or a contraindication to splenectomy.
- Give written informed consent.
- Use an effective means of contraception during treatment and for six months after completion of treatment.
- Have negative serum pregnancy test, for all women who are able to have children, within 14 days prior to study entry.
Exclusion
- Male and female subjects will be ineligible to participate if they:
- Received prior treatment with cyclophosphamide within the last 3 months.
- Received prior treatment with \> 4 infusions of vinca alkaloids within the 6 months.
- Had previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.
- Have an HIV infection.
- Have hepatitis Bs antigen positivity or active hepatitis C infection
- Have an absolute neutrophil count \< 1.000/mm3 at study entry (unless related to autoimmune neutropenia).
- Have a Hemoglobin level \< 10 g/dl other than caused by thalassemia trait, iron deficiency or autoimmune hemolytic anemia (patients with Evan's syndrome will not be excluded).
- Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL.
- Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an AST or ALT level \> 3x upper limit of normal.
- Have active infection requiring antibiotic therapy within 7 days prior to study entry.
- Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug.
- Have had a prior severe reaction to Rituximab, leading to discontinuation of treatment.
- Have a New York Heart Classification III or IV heart disease.
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161564
Start Date
February 1 2004
Last Update
July 17 2018
Active Locations (1)
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1
Weill Medical College of Cornell University Division of Pediatric Hematology-Oncology
New York, New York, United States, 10021