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

Completed · Phase 2/Phase 3

Conditions studied: Immune Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID: NCT00774202
Run by: Weill Medical College of Cornell University
People needed: 17
Starts: 2003-11-01
Expected to finish: 2008-02-01
Last updated by the study team: 2019-01-09

Who can join

Age: 12 and older, up to 100. 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
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

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 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

Where it is running

525 East 68th Street — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.