A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard doses of rituximab.

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

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

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.

• 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 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 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.