Status:
COMPLETED
Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Biogen
Genentech, Inc.
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
12-100 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or rel...
Detailed Description
The rationale for using chemotherapy in combination with Rituximab: Since Rituximab is an anti-B cell therapy, in order to improve the rate of durable responses beyond the 32% (18 of 57) seen with Ri...
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
- We will allow patients who do not have 2 platelet counts \< 30,000 on two separate occasions 1-2 weeks apart in the past month, as long as they have either Evan's Syndrome or autoimmune neutropenia (have hemoglobin \< 10 g/dL and reticulocytes \> 4%, or an absolute neutrophil count \< 1.0 K/uL twice within 1 month)
- Are age ≥ 10 years old
- Male and Female
- 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 a 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 :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00774202
Start Date
November 1 2003
End Date
February 1 2008
Last Update
January 9 2019
Active Locations (1)
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1
525 East 68th Street
New York, New York, United States, 10065