The PROLONG Trial - Rituximab Maintenance Therapy in ITP

Conditions

• Purpura, Thrombocytopenic, Idiopathic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  Comparing the effect of Rituximab infusion With or without Dexamethasone
• Rituximab — DRUG
  Comparing maintenance dose of 500mg Rituximab at week 1 and week 24 to Placebo

Study Details

This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance therapy may prolong the the effect of Rituximab in immune thrombocytopenia.

Key Dates

Start date

Dec 31, 2016

Status verified

Nov 2023

Primary completion

Dec 31, 2024

Completion

Dec 31, 2024

Study Design

Enrollment

136 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Induction phase: Rituximab+Dexamethasone
  Open-label, intravenous infusions of rituximab 1000 mg and oral dexamethasone 20 mg daily for 4 days given on day 1 and day 15.
• No Intervention: Induction phase: Rituximab
  Open-label, intravenous infusions of rituximab 1000 mg given on day 1 and day 15.
• Experimental: Maintenance phase: Rituximab
  Patients who respond to rituximab in the induction phase will be proceed into the maintenance phase and randomized to rituximab infusion of 500 mg in week 1 and week 24, or
• No Intervention: Maintenance phase: Placebo
  Infusion of normal saline 0,9% in week 1 ande week 24 in second randomization.

Primary Outcome Measure

Sustained of overall response [ Time Frame: 52 weeks ]