Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Sponsor
David Gomez Almaguer
Study ID
NCT04588194
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Thrombocytopenia
  • Thrombotic Thrombocytopenic Purpura

Eligibility Criteria

Sex
ALL
Age
16 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Romiplostim — DRUG
    Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21
  • Rituximab — DRUG
    Rituximab 100 mg weekly days 1, 7, 14, 21
  • Dexamethasone — DRUG
    40 mg IV/PO days 1-4

Study Details

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab, romiplostim and high-dose dexamethasone.

Key Dates

Start date
Nov 1, 2020
Status verified
Oct 2020
Primary completion
Nov 1, 2021
Completion
Nov 1, 2022

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Romiplostim, Rituximab, Dexamethasone
    Each patient will receive Rituximab 100 mg weekly days 1, 7, 14, 21, Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21 and Dexamethasone 40 mg IV/PO days 1-4.

Primary Outcome Measure

Clinical Response [ Time Frame: 28 days ]

Central Contacts

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