The PROLONG Trial - Rituximab Maintenance Therapy in ITP
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|ClinicalTrials.gov Identifier: NCT03010202|
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Purpura, Thrombocytopenic, Idiopathic||Drug: Dexamethasone Drug: Rituximab||Phase 3|
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.
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.
- 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).
- To assess the safety of study treatment, especially infectious episodes (induction & maintenance phases).
- To assess bleeding complications during the study (induction & maintenance phases).
- To assess the use of rescue medications and other platelet-elevating therapies during the study (induction & maintenance phases).
- To determine rate of Complete Response (CR) during induction phase and sustained CR during maintenance phase (induction & maintenance phases).
- To determine the duration of overall response and CR (induction & maintenance phases).
- To assess health-related quality of life and fatigue (induction & maintenance phases).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prolonging the Response by Low-dose Rituximab Maintenance Therapy in Immune Thrombocytopenia: a Randomized Placebo-controlled Trial - the PROLONG Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
Comparing the effect of Rituximab infusion With or without Dexamethasone
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
Comparing maintenance dose of 500mg Rituximab at week 1 and week 24 to Placebo
Other Name: Mabthera
No Intervention: Maintenance phase: Placebo
Infusion of normal saline 0,9% in week 1 ande week 24 in second randomization.
- Sustained of overall response [ Time Frame: 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).
- Improvement at overall response rate in week 24 [ Time Frame: 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) [ Time Frame: 24 weeks and 52 weeks ]Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases).
- Grade of bleeding during the study (during both phases) [ Time Frame: 24 weeks and 52 weeks ]Grade of bleeding (this endpoint applies to both phases).
- Sustained Complete Response (CR) during maintenance phase [ Time Frame: 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
- Complete Response during induction phase [ Time Frame: 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)
- Rescue medication or other elevating platelet therapy [ Time Frame: after 12 weeks in induction phase and 40 weeks in maintenance phase ]
Administration of rescue medication or other elevating platelet therapy
- After week 12 (induction phase)
- During maintenance phase (maintenance phase).
- Platelet count Levels > 50 x 109/L during maintenance phase [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010202
|Contact: Waleed Ghanima, PhD||+47 email@example.com|
|Contact: Pål André Holme, PhD|
|Ostfold Hospital Trust||Recruiting|
|Sarpsborg, Norway, 1714|
|Contact: Waleed Ghanima, PhD|
|Principal Investigator:||Waleed Ghanima, PhD||Ostfold Hospital Trust|