A Study to Evaluate IONIS-TMPRSS6-LRx (ISIS 702843) in Patients with Polycythemia Vera

Overview

About this study

The main purpose of this study is to evaluate the effectiveness of IONIS-TMPRSS6-LRx in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis.

2. Participant must be phlebotomy dependent.

3. The participant's cytoreductive therapy must either be discontinued at least 3 months prior to Screening, OR participant must be on a stable dose for at least 3 months
prior to Screening.

Exclusion Criteria:

1. Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment.
(IWG-MRT).

2. Moderate to severe splenic pain or spleen-related organ obstruction.

3. Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP).

4. Known primary or secondary immunodeficiency.

5. Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.

6. Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection.

7. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or non-metastatic prostate cancer that has been
successfully treated.

8. Surgery requiring general anesthesia within 1 month prior to Screening.

Eligibility last updated 8/26/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available