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Recruiting NCT07007962

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

Phase III Interventional Immune Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rilzabrutinib.
Who it may be relevant to
Registry conditions: Immune Thrombocytopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Czechia, France, Germany +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

Overview

This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.

Interventions

  • Drug rilzabrutinib
    Pharmaceutical form:Tablet-Route of administration:Oral

Primary outcome measures

  • Durable platelet response [Time frame: Until Week 28]
Secondary outcome measures (6)
  • Overall platelet response [Time frame: Until Week 28]
  • Duration of platelet response [Time frame: Until Week 28]
  • Change from baseline in the immune thrombocytopenia bleeding scale (IBLS) score at the end of week 28 [Time frame: Until Week 28]
  • Percentage of participants able to discontinue or reduce CS dose by at least 50% or to <5 mg/day (prednisone equivalent) from baseline at the end of week 28 [Time frame: Until Week 28]
  • Frequency and severity of treatment emergent adverse events (TEAEs, including serious adverse events [SAEs], bleeding TEAEs, adverse event of special interest [AESI] and adverse events leading to discontinuation) [Time frame: Until Week 80]
  • Percentage of participants with potential clinical significant abnormal (PCSA) [Time frame: Until Week 80]

Eligibility criteria

Inclusion criteria

  • Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history
  • Participant received at least one course of first-line therapy and had a history of response while on treatment
  • Participant has loss of response, relapse, or steroid dependency

Exclusion criteria

  • Participants with Secondary ITP
  • Participants with Evans syndrome or history of myelodysplastic syndrome
  • Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.
  • Participants with history of solid organ transplant
  • Participants with history of coagulation or bleeding disorders other than ITP, including genetic conditions, other than ITP
  • Participant received advanced therapy for ITP or was splenectomized
  • Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncol — Clovis
  • University of Southern California (USC) — Los Angeles
  • Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400 — New Orleans
  • Massachusetts General Hospital Cancer Center — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • Mass General Brigham Cancer Institute — Danvers
  • University of Michigan Health - Michigan Medicine - University Hospital-Investigational Si — Ann Arbor
  • Mayo Clinic_Investigational Site Number: 8400009 — Rochester
  • … and 4 more centers
Spain · 7 centers
  • Investigational Site Number : 7240001 — Barcelona
  • Investigational Site Number : 7240002 — Burgos
  • Investigational Site Number : 7240007 — Madrid
  • Investigational Site Number : 7240008 — Madrid
  • Investigational Site Number : 7240005 — Murcia
  • Investigational Site Number : 7240003 — San Cristóbal de La Laguna
  • Investigational Site Number : 7240004 — Seville
Italy · 5 centers
  • Investigational Site Number : 3800002 — Meldola
  • Investigational Site Number : 3800004 — Milan
  • Investigational Site Number : 3800006 — Naples
  • Investigational Site Number : 3800007 — Torino
  • Investigational Site Number : 3800003 — Vicenza
France · 4 centers
  • Investigational Site Number: 2500003 — Créteil
  • Investigational Site Number : 2500001 — Dijon
  • Investigational Site Number : 2500002 — Pessac
  • Investigational Site Number : 2500004 — Toulouse
Poland · 3 centers
  • Investigational Site Number : 6160002 — Gdansk
  • Investigational Site Number : 6160003 — Skorzewo
  • Investigational Site Number : 6160004 — Słupsk
Hungary · 2 centers
  • Investigational Site Number : 3480001 — Budapest
  • Investigational Site Number : 3480002 — Kaposvár
Austria · 1 center
  • Investigational Site Number : 0400001 — Vienna
Czechia · 1 center
  • Investigational Site Number : 2030002 — Prague
Germany · 1 center
  • Investigational Site Number : 2760004 — Leipzig

Identifiers

NCT: NCT07007962 · LPS18573 · U1111-1320-4669

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗