Evaluation of Parsaclisib plus Ruxolitinib in patients with Myelofibrosis who have not responded to Ruxolitinib alone

Purpose

The purpose of this study is to study whether the condition of patients with myelofibrosis who have previously not responded to a treatment on Ruxolitinib would improve on Parsaclisib plus Ruxolitinib.

Costs

Participation in the clinical trial is free of charge.

Condition

Myelofibrosis

Trial phase

Phase 3 trial (what are the 4 phases of clinical trials?)

Countries

Austria, Belgium, Finland, France, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Romania, Spain, Turkey, UK

Which Myelofibrosis patients can access this clinical trial?

Patients who wish to participate in this clinical trial need to fulfill a number of eligibility criteria. Some are very specific and we will require the medical records from your doctor.

You could be eligible if:

  • You can take part in the trial in Austria, Belgium, Finland, France, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Romania, Spain, Turkey, UK;
  • You have a diagnosis of Primary Myelofibrosis (PMF), Post-polycytemia vera (PPV-MF), or Post-essential thrombocythemia (PET-MF);
  • You have a DIPSS (Dynamic International Prognostic Scoring System for myelofibrosis) risk category of intermediate-1, intermediate-2, or high;
  • You have been treated with ruxolitinib for more than 3 months with a stable dose for at least 8 weeks (acceptable doses are 5 mg BID to 25 mg BID, split doses are allowed [total daily dose at least 10 mg], QD dosing is not allowed);
  • You have had a suboptimal response to ruxolitinib (a palpable spleen of ≥ 5 cm below the left subcostal margin plus active symptoms of MF;

If you meet all of these conditions you might be allowed to enter the screening process.

You are not eligible if:

  • You are not receiving treatment in one of the countries specified for this study;
  • You have been under treatment with a drug similar to parsaclisib such as: idelalisib, duvelisib, buparlisib, copanlisib and umbralisib;
  • You have been under treatment with an experimental drug therapy for MF or any other standard drug used for MF (eg, danazol, hydroxyurea) with the exception of ruxolitinib, within 3 months of starting this study;
  • You have an active Hepatitis B or C infection that requires treatment or are at risk for HBV reactivation;
  • You have an HIV infection;
  • You have a severe or unstable cardiac disease;
  • You have had a splenic irradiation within 6 months before starting this study;
  • You have a history of Grade 3 or 4 irAEs from prior immunotherapy (if you have had Grade 1 or 2, it must be resolved before starting this study).

If you meet all of these conditions you might be allowed to enter the screening process.

Learn how to access this clinical trial

If you meet the conditions and you would like to participate in this study, please register your interest by filling in the Participation Form and we will contact you shortly with additional information on the screening process.

Be fully informed before you show interest in taking part in this study

Joining a clinical trial study can be unnerving for both you and your loved ones, which is why you first need to consult your treating doctor to weigh up the pros and cons. We will try to give you all the information you and your doctor need, so you and your doctor can make the best decision for you.

Please be aware that as part of the screening process you and your doctor will need to send us your medical records.

Be aware:

  • Being selected for the study depends on whether you are eligible for the trial;
  • At all times your data will be kept safe and protected;
  • If you join the trial, you could be randomly assigned to a placebo group.

Yes, I want to participate

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Thank you for registering your interest in this clinical trial!

We will get in touch with you shortly at . If you have any questions, send an email to [email protected]

459 Evaluation of Parsaclisib plus Ruxolitinib in patients with Myelofibrosis who have not responded to Ruxolitinib alone
US