Rituximab and Dexamethasone Followed by Mycophenolate Mofetil or Placebo in Patients With Immune … (NCT02649504) | Clinical Trial Compass
WithdrawnPhase 3
Rituximab and Dexamethasone Followed by Mycophenolate Mofetil or Placebo in Patients With Immune Thrombocytopenia
0Started 2016-12-01
Plain-language summary
The investigators will attempt to further increase the cure rate of ITP with medical therapy by providing maintenance therapy with Mycophenolate mofetil (MMF) to persistent/chronic ITP patients after treating them with induction therapy combining rituximab and dexamethasone. The investigators will randomly assign patients to MMF versus placebo in order to demonstrate safety (e.g., for infectious risk) and efficacy (platelet counts stably \>50x109/L more than 1 year off therapy).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female, greater than 18 years old
* Signed written informed consent obtained prior to study entry
* Immune Thrombocytopenia according to the American Society of Hematology guidelines, with other potential causes of thrombocytopenia excluded, platelets less than 30 x 109/L at study entry
* Have adequate renal and hepatic function (creatinine and bilirubin less than 2 x Upper Limit of Normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 3 x ULN)
* No significant cytopenias (hemoglobin greater than10 g/dL without ongoing transfusional support, absolute neutrophil count greater than 1.0 x109/L at study entry).
* If on corticosteroids, receiving less than or equal to 20 mg/day prednisone (or equivalent) with no change of dose for at least 2 weeks prior to study entry. No more than two 4-day courses of Dexamethasone prior to study entry. If on danazol, no change of dose for at least 2 weeks prior to study entry. (Thrombopoietin receptor agonist treatment will be allowed until the end of 8th week on study if started prior to study entry)
* No treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half-lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
* No prior treatment with anti-B-lymphocyte antigen cluster of differentiation antigen 20 monoclonal antibody at a total dose greater than 375mg/m2
* Screen for …
What they're measuring
1
Number of patients with a platelet count greater or equal to 50,000 for 5 of 6 platelet counts in the second half of second year (month 19 to month 24) with no rescue therapy
Timeframe: 2 years
Trial details
NCT IDNCT02649504
SponsorWeill Medical College of Cornell University