Education and Training

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease.

This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Idelalisib
  • drug: Ruxolitinib

Eligibility


Key Inclusion Criteria:

   - Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior
   to study entry

   - Individuals with PMF, post-PV MF, or post-ET MF classified as high risk or
   intermediate risk as defined by the Dynamic International Prognostic Scoring System
   (DIPSS) for PMF or DIPSS Plus, if cytogenetics are available

   - Individuals with PMF, post-PV MF, or post-ET MF who are receiving ruxolitinib and meet
   2013 Revised International Working Group for Myelofibrosis Research and Treatment
   (IWG-MRT) and European Leukemia Net (ELN) response criteria with progressive and
   relapsed disease, with modifications for progressive disease complete remission (CR),
   partial remission (PR), or clinical improvement (CI)

   - European Cooperative Oncology Group (ECOG) performance status of ≤ 2

   - Required screening laboratory values as described in the protocol

   - Willing and able to comply with scheduled visits, drug administration plan, imaging
   studies, laboratory tests, other study procedures, and study restrictions including
   mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP)

   - Able to understand and willing to sign the informed consent form

Key Exclusion Criteria:

   - Individuals on a stable ruxolitinib dose of 5 mg once daily

   - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

   - Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic
   steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by
   cholelithiasis, cirrhosis of the liver

   - Ongoing drug-induced pneumonitis

   - Ongoing inflammatory bowel disease

   - Ongoing alcohol or drug addiction

   - Symptomatic congestive heart failure (New York Heart Association Classification >
   Class II), unstable angina, or unstable cardiac arrhythmia requiring medication

   - Known hypersensitivity to the study investigational medicinal product (IMP), the
   metabolites, or formulation excipients

   - Unwilling or unable to take oral medication

   - Unresolved non-hematologic toxicities from prior therapies that are > Common
   terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of
   alopecia [Grade 1 or 2 permitted])

   - Pregnant or lactating females

   - Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28
   days

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting