Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis (NCT04468984)
🩺 Plain-English Summary (8th-Grade Level)
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. In Arm C, participants will receive navitoclax tablet by mouth once daily. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (5 items).
Location: Ironwood Cancer & Res Ctr /ID# 222162 — Chandler, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Received prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, phosphoinositide 3- kinase and telomerase inhibitors (e.g., parsaclisib), prior use of \> 1 JAK2 inhibitor or stem cell transplant.
- Eligible for stem cell transplantation at the time of study entry.
- Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).
- Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (229 Sites)
- Ironwood Cancer & Res Ctr /ID# 222162 — Chandler, Arizona
- Highlands Oncology Group, PA /ID# 221826 — Springdale, Arkansas
- City of Hope /ID# 218996 — Duarte, California
- Providence - St. Jude Medical Center /ID# 271382 — Fullerton, California
- Moores Cancer Center /ID# 271596 — La Jolla, California
- Moores Cancer Center at UC San Diego /ID# 219009 — La Jolla, California
- Long Beach Memorial Medical Ct /ID# 224542 — Long Beach, California
- Icri /Id# 221967 — Whittier, California
- St. Mary's Hospital Regional Cancer Center /ID# 224229 — Grand Junction, Colorado
- Augusta University Georgia Cancer Center /ID# 219051 — Augusta, Georgia
- Columbus Regional Research Institute /ID# 224410 — Columbus, Georgia
- University of Chicago Medical Center /ID# 271373 — Chicago, Illinois
- Northwest Oncology & Hematology - Elk Grove Village /ID# 222818 — Elk Grove Village, Illinois
- Loyola University Medical Ctr /ID# 219048 — Maywood, Illinois
- Indiana Blood & Marrow Transpl /ID# 221587 — Indianapolis, Indiana
- Tulane Medical Center - New Orleans /ID# 222940 — New Orleans, Louisiana
- Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777 — New Orleans, Louisiana
- American Oncology Partners of Maryland /ID# 222836 — Bethesda, Maryland
- Dana-Farber Cancer Institute /ID# 218998 — Boston, Massachusetts
- University of Michigan /ID# 218463 — Ann Arbor, Michigan
- Henry Ford Hospital /ID# 221190 — Detroit, Michigan
- William Beaumont Hospital /ID# 222705 — Royal Oak, Michigan
- Saint Louis University Cancer Center /ID# 222287 — St Louis, Missouri
- Summit Medical Group-Florham Park /ID# 222620 — Florham Park, New Jersey
- Hackensack Univ Med Ctr /ID# 219047 — Hackensack, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.