A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis

  • STATUS
    Recruiting
  • End date
    Feb 2, 2029
  • participants needed
    164
  • sponsor
    AbbVie
Updated on 29 April 2021

Summary

www.MyelofibrosisResearch.com

This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

Description


Details
Condition Myelofibrosis
Treatment Ruxolitinib, Navitoclax
Clinical Study IdentifierNCT03222609
SponsorAbbVie
Last Modified on29 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis
Participant must be ineligible or unwilling to undergo stem cell transplantation at time of study entry
Eastern Cooperative Oncology Group (ECOG) of 0,1, or 2
Participant must have either received prior treatment with ruxolitinib OR another Janus Kinase 2 (JAK-2) inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor or BET inhibitor
Participant has splenomegaly as defined in the protocol
Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol

Exclusion Criteria

Splenic irradiation within 6 months prior to screening, or prior splenectomy
Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy)
Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin
Prior therapy with a BH3 mimetic compound
Participant has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note