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

Withdrawn before enrolling · Phase 2

Conditions studied: Idiopathic Thrombocytopenic Purpura (ITP)

In brief

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.

Key facts

Study ID

NCT00161564

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2004-02-01

Last updated by the study team

2018-07-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Weill Medical College of Cornell University Division of Pediatric Hematology-Oncology — New York, New York, United States

Full record on ClinicalTrials.gov

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