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
Public ClinicalTrials.gov record NCT04468984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C - Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04468984
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2020 (Actual)
- Primary completion
- Jan 29, 2025 (Actual)
- Completion
- Dec 2026 (Estimated)
- Last update posted
- Jan 9, 2026
2020 – 2026
United States locations
- U.S. sites
- 41
- U.S. states
- 22
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer & Res Ctr /ID# 222162 | Chandler | Arizona | 85224-5665 | — |
| Highlands Oncology Group, PA /ID# 221826 | Springdale | Arkansas | 72762 | — |
| City of Hope /ID# 218996 | Duarte | California | 91010 | — |
| Providence - St. Jude Medical Center /ID# 271382 | Fullerton | California | 92835 | — |
| Moores Cancer Center /ID# 271596 | La Jolla | California | 92037 | — |
| Moores Cancer Center at UC San Diego /ID# 219009 | La Jolla | California | 92093 | — |
| Long Beach Memorial Medical Ct /ID# 224542 | Long Beach | California | 90806-1701 | — |
| Icri /Id# 221967 | Whittier | California | 90603 | — |
| St. Mary's Hospital Regional Cancer Center /ID# 224229 | Grand Junction | Colorado | 81501-6132 | — |
| Augusta University Georgia Cancer Center /ID# 219051 | Augusta | Georgia | 30912-0003 | — |
| Columbus Regional Research Institute /ID# 224410 | Columbus | Georgia | 31904-8915 | — |
| University of Chicago Medical Center /ID# 271373 | Chicago | Illinois | 60637 | — |
| Northwest Oncology & Hematology - Elk Grove Village /ID# 222818 | Elk Grove Village | Illinois | 60007-3361 | — |
| Loyola University Medical Ctr /ID# 219048 | Maywood | Illinois | 60153 | — |
| Indiana Blood & Marrow Transpl /ID# 221587 | Indianapolis | Indiana | 46237 | — |
| Tulane Medical Center - New Orleans /ID# 222940 | New Orleans | Louisiana | 70112-2600 | — |
| Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777 | New Orleans | Louisiana | 70121 | — |
| American Oncology Partners of Maryland /ID# 222836 | Bethesda | Maryland | 20817 | — |
| Dana-Farber Cancer Institute /ID# 218998 | Boston | Massachusetts | 02215 | — |
| University of Michigan /ID# 218463 | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital /ID# 221190 | Detroit | Michigan | 48202 | — |
| William Beaumont Hospital /ID# 222705 | Royal Oak | Michigan | 48073-6710 | — |
| Saint Louis University Cancer Center /ID# 222287 | St Louis | Missouri | 63110-2539 | — |
| Summit Medical Group-Florham Park /ID# 222620 | Florham Park | New Jersey | 07932-1049 | — |
| Hackensack Univ Med Ctr /ID# 219047 | Hackensack | New Jersey | 07601 | — |
| The Cancer Institute at St. Francis Hospital /ID# 231782 | Greenvale | New York | 11548-1219 | — |
| Manhattan Hematology Oncology MHO Associates /ID# 223193 | New York | New York | 10016-6028 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081 | New York | New York | 10065-6007 | — |
| Atrium Health Wake Forest Baptist Medical Center /ID# 222899 | Winston-Salem | North Carolina | 27157-0001 | — |
| MetroHealth Medical Center /ID# 222650 | Cleveland | Ohio | 44109 | — |
| Pennsylvania Cancer Specialists & Research Institute /ID# 271376 | Gettysburg | Pennsylvania | 17325 | — |
| Hospital of the University of Pennsylvania /ID# 219001 | Philadelphia | Pennsylvania | 19104-4238 | — |
| Fox Chase Cancer Center /ID# 223955 | Philadelphia | Pennsylvania | 19111 | — |
| Texas Oncology - Abilene - Antilley Road /ID# 271379 | Abilene | Texas | 79606 | — |
| Duplicate_Houston Methodist Hospital /ID# 223103 | Houston | Texas | 77030 | — |
| University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942 | San Antonio | Texas | 78229 | — |
| Utah Cancer Specialists Salt Lake Clinic /ID# 221962 | Salt Lake City | Utah | 84106 | — |
| Virginia Cancer Specialists - Fairfax /ID# 223016 | Fairfax | Virginia | 22031 | — |
| Providence Everett /ID# 223130 | Everett | Washington | 98201 | — |
| Yakima Valley Memorial Hosp /ID# 224368 | Yakima | Washington | 98902-6388 | — |
| HSHS St. Vincent Hospital /ID# 224468 | Green Bay | Wisconsin | 54301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 188 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04468984, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 9, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04468984 live on ClinicalTrials.gov.