Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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 relapsed after standard doses of Rituxan. Patients eligible for this protocol will be stratified into two subgroups according to their initial response to Rituxan.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborators: Biogen; Genentech, Inc.
• Treatments: Cyclophosphamide; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

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 Criteria:

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