The PROLONG Trial - Rituximab Maintenance Therapy in ITP

Phase 3

Active, not recruiting

• Conditions: Purpura, Thrombocytopenic, Idiopathic
• Interventions: Drug: Dexamethasone; Drug: Rituximab

• Registration Number: NCT03010202
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

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.

Detailed Description

This is a multi-center, international, randomized, two-phase study:

First phase (induction phase) is open-label, hypothesis-generating, involving 1:1 randomization into: rituximab (group 1) or rituximab plus dexamethasone (group 2) to determine if the response to rituximab can be improved by the addition of dexamethasone.

Second Phase (maintenance phase) is the main part of the study, involving 1:1 double-blind randomization into low dose rituximab or placebo to determine if the response achieved in the first phase can be prolonged by administrating maintenance treatment with low dose rituximab.

Primary objective:

To determine if maintenance therapy with low-dose rituximab is superior to placebo in prolonging responses among ITP patients who achieved an initial response with rituximab.

Secondary objectives:

1. To explore if the initial overall response rate, at week 24, can be improved by at least 10% by adding dexamethasone to rituximab (induction phase).

2. To assess the safety of study treatment, especially infectious episodes (induction \& maintenance phases).

3. To assess bleeding complications during the study (induction \& maintenance phases).

4. To assess the use of rescue medications and other platelet-elevating therapies during the study (induction \& maintenance phases).

5. To determine rate of Complete Response (CR) during induction phase and sustained CR during maintenance phase (induction \& maintenance phases).

6. To determine the duration of overall response and CR (induction \& maintenance phases).

7. To assess health-related quality of life and fatigue (induction \& maintenance phases).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Status Verified: 2023-11
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induction phase: Rituximab+Dexamethasone	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.
Maintenance phase: Rituximab	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

Primary Outcome Measures

Name	Time	Method
Sustained of overall response	52 weeks	sustained overall response during maintenance phase \[loss of overall response is defined as: (1) two consecutive measurements with platelet counts \< 50 x 109/L taken at 1-8-week interval, and/or, (2) use of any ITP-directed therapies, other than study medication, because of bleeding or thrombocytopenia, except for preoperative elevation of platelet count\] (this endpoint applies to maintenance phase only).

Secondary Outcome Measures

Name	Time	Method
Grade of bleeding during the study (during both phases)	24 weeks and 52 weeks	Grade of bleeding (this endpoint applies to both phases).
Rescue medication or other elevating platelet therapy	after 12 weeks in induction phase and 40 weeks in maintenance phase	Administration of rescue medication or other elevating platelet therapy; 1. After week 12 (induction phase); 2. During maintenance phase (maintenance phase).
Sustained Complete Response (CR) during maintenance phase	52 weeks	Sustained Complete Response (CR) during maintenance phase defined as platelet count \> 100 x 109/L maintained during maintenance phase, without the use of any ITP-directed therapies
Platelet count Levels > 50 x 109/L during maintenance phase	phase 2 (52 weeks)	Percentage of patients with more than 80% of platelet counts level \> 50 x 109/L during the maintenance phase (this endpoint applies to maintenance phase only).
Health related quality of life	First phase at 24 weeks and second phase at 52 weeks	Health-related quality of life assessed by SF-36 questionnaire (this endpoint applies to both phases).
Improvement at overall response rate in week 24	Week 24 (+/- 2 weeks)	Overall response during induction phase defined as mean platelet count, determined in week 24 (± 2 weeks) after induction therapy, \> 50 x 10E9/L , without use of any other ITP-directed therapies after week 12 following the first randomization (this endpoint applies to induction phase only).
Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases)	24 weeks and 52 weeks	Safety assessed by the frequency of \> grade II adverse events (this endpoint applies to both phases).
Complete Response during induction phase	24 weeks (+/- 2 weeks)	Complete Response (CR) during induction phase defined as platelet count, determined in week 24 (± 2 weeks), \> 100 x 109/L without use of any other ITP-directed therapies after week 12 following the first randomization (induction phase)

Trial Locations

Locations (1)

Ostfold Hospital Trust; 🇳🇴 Sarpsborg, Norway