A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (HEMA-MED)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with Myelofibrosis. The main questions it aims to answer is to evaluate the safety and tolerability of roginolisib when administered in combination with ruxolitinib.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years of age inclusive, at the time of signing the informed consent.

• Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Diagnosis of MF, Post-Polycythaemia Vera Myelofibrosis MF (PPV-MF), or post-essential thrombocythemia MF (PET-MF)

• Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1, intermediate-2, or high

• Treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for a minimum of 8 weeks prior to Day 1. Furthermore, patients must show an unsatisfactory spleen reduction, such as a reduction of less than 25%, and spleen must be palpable ≥ 10 cm below the left costal margin on physical examination

• Did not receive experimental drug therapy for MF or any other drug considered as an effective treatment for MF (e.g., danazol, hydroxyurea, interferon products) with the exception of ruxolitinib, within 3 months of starting study drug (except in conditions where other effective treatments for MF were completed 6 months prior to starting ruxolitinib)

• Independent of spleen size, active symptoms of MF at the screening visit, as demonstrated by the presence of a Total Symptom Score (TSS) of ≥ 10 using the Screening Symptom Form.

• Peripheral blast count \< 10%

⁃ Act to avoid pregnancy or fathering children based on the criteria below:

∙ Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age).

‣ Women of childbearing potential who had a negative serum pregnancy test at screening and who agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up, at least 1 month after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed.

‣ Men who agree to take appropriate precautions to avoid fathering from screening through safety follow-up, at least 1 month after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix 3) should be communicated to the patient and their understanding confirmed.

Locations
Other Locations
Italy
Azienda Ospedaliero Universitaria Careggi Firenze, Struttura Complessa di Ematologia
RECRUITING
Florence
IRCCS Clinical Institute Humanitas
RECRUITING
Rozzano
Spain
Avigunda Gran via de l'Hospitalet 199-203, 08908 L'Hospitalet de Llobregat
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Tracey Hammett, RN
t.hammett@ionctura.com
+44 7776498978
Backup
Karen Tonge
k.tonge@ionctura.com
+44 7770678446
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2028-07
Participants
Target number of participants: 26
Treatments
Experimental: Single Arm
Roginolisib and ruxolitinib
Related Therapeutic Areas
Sponsors
Leads: iOnctura

This content was sourced from clinicaltrials.gov