Rituximab and Dexamethasone Followed by Mycophenolate Mofetil or Placebo in Patients With Immune Thrombocytopenia

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02649504
Phase
PHASE3
Status
Withdrawn

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab will be given at the standard dose of 375mg/m2 on days 1, 8, 15, 22 of the study
  • Dexamethasone — DRUG
    Dexamethasone will be given at dose 40 mg/day on days 1-4, 15-18, and 29-32 (+/- 3 days) of the study.
  • Mycophenolate mofetil — DRUG
    Patients allocated to the active drug arm will be given Mycophenolate mofetil starting on day 33, 500 mg twice daily for the first week and then escalation to 1000 mg twice daily for 24 weeks.
  • Placebo — DRUG
    Patients allocated to the placebo arm will be given placebo starting on day 33, 500 mg twice daily for the first week and then escalation to 1000 mg twice daily for 24 weeks.

Study Details

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).

Key Dates

Start date
Dec 1, 2016
Status verified
Aug 2018
Primary completion
Dec 1, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: R+3D, MMF
    Rituximab will be given at the standard dose of 375mg/m2 on days 1, 8, 15, 22 of the study. Dexamethasone will be given at dose 40 mg/day on days 1-4, 15-18, and 29-32 (+/- 3 days) of the study. Mycophenolate mofetil (MMF) will be given starting on day 33, 500 mg twice daily for the first week and then escalation to 1000 mg twice daily for 24 weeks.
  • Placebo Comparator: R+3D, Placebo
    Rituximab will be given at the standard dose of 375mg/m2 on days 1, 8, 15, 22 of the study. Dexamethasone will be given at dose 40 mg/day on days 1-4, 15-18, and 29-32 (+/- 3 days) of the study. Placebo will be given starting on day 33, 500 mg twice daily for the first week and then escalation to 1000 mg twice daily for 24 weeks.

Primary Outcome Measure

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 [ Time Frame: 2 years ]

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