Phase 3
Completed N=17
Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP
Immune Thrombocytopenic Purpura
Source: ClinicalTrials.gov NCT00774202 ↗
Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Nov 2018
Primary outcomePrimary: Efficacy of Higher Double Doses of Rituxan and of Standard Dose of Rituxan + Cyclophosphamide, Vincristine, Prednisone — 8; 7; 1; 1 Participants
◆ Published Evidence
Established
68citations · ~4 / year
Repeated courses of rituximab in chronic ITP: Three different regimens.
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.
Linked Publications
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Repeated courses of rituximab in chronic ITP: Three different regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Higher Double Doses of Rituxan and of Standard Dose of Rituxan + Cyclophosphamide, Vincristine, Prednisone |
8; 7; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With SAEs |
0; 1 | — |
| SECONDARY Relative Efficacy of the 2 Groups |
4; 4; 1; 0; 0; 0 | — |
Eligibility 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 4%, or an absolute neutrophil count 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 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
Data sourced from ClinicalTrials.gov (NCT00774202) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.