Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

A Phase 2 Single-Arm, Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis

Keywords

Myelofibrosis (MF) Post-polycythemia vera MF (PPV-MF) Post-essential thrombocythemia (PET-MF) ruxolitinib navitoclax splenic volume Primary Myelofibrosis Jakafi enlarged spleen splenomegaly ABT 263 bone marrow fibrosis Navitoclax + ruxolitinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants with documented diagnosis of 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
  • Participant must have received ruxolitinib therapy for at least 24 weeks and be currently on a stable dose of >= 10 mg BID of ruxolitinib for >= 8 weeks prior to the 1st dose of navitoclax, ECOG of 0,1, or 2.

You CAN'T join if...

  • Splenic irradiation within 12 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.

Locations

  • Ucsd /Id# 164084 accepting new patients
    La Jolla California 92037 United States
  • Usc /Id# 164095 accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03222609
Phase
Phase 2
Study Type
Interventional
Last Updated
July 31, 2018