Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
Public ClinicalTrials.gov record NCT04472598. 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
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.
Study identification
- NCT ID
- NCT04472598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 252 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
- Sep 29, 2020 (Actual)
- Primary completion
- Apr 13, 2023 (Actual)
- Completion
- Jan 29, 2025 (Actual)
- Last update posted
- Mar 23, 2026
2020 – 2025
United States locations
- U.S. sites
- 35
- U.S. states
- 21
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group, PA /ID# 221824 | Springdale | Arkansas | 72762 | — |
| Providence - St. Jude Medical Center /ID# 241646 | Fullerton | California | 92835 | — |
| Moores Cancer Center at UC San Diego /ID# 218012 | La Jolla | California | 92093 | — |
| Rocky Mountain Cancer Centers - Littleton /ID# 222562 | Littleton | Colorado | 80120 | — |
| Lynn Cancer Institute, Boca /ID# 230687 | Boca Raton | Florida | 33486 | — |
| Florida Cancer Specialist - South /ID# 221726 | Fort Myers | Florida | 33901-8108 | — |
| Florida Cancer Specialists - North /ID# 221727 | St. Petersburg | Florida | 33705-1449 | — |
| Florida Cancer Specialists - East /ID# 221728 | West Palm Beach | Florida | 33401 | — |
| Duplicate_Emory University /ID# 221562 | Atlanta | Georgia | 30322-1013 | — |
| Augusta University Georgia Cancer Center /ID# 221551 | Augusta | Georgia | 30912-0003 | — |
| Columbus Regional Research Institute /ID# 227272 | Columbus | Georgia | 31904-8915 | — |
| Duplicate_Rush University Medical Center /ID# 221581 | Chicago | Illinois | 60612 | — |
| Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204 | Normal | Illinois | 61761 | — |
| Indiana Blood & Marrow Transpl /ID# 221586 | Indianapolis | Indiana | 46237 | — |
| University of Kansas Cancer Center /ID# 218144 | Fairway | Kansas | 66205-2528 | — |
| Massachusetts General Hospital /ID# 221559 | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center /ID# 224261 | Boston | Massachusetts | 02215-5400 | — |
| Dana-Farber Cancer Institute /ID# 218010 | Boston | Massachusetts | 02215 | — |
| University of Michigan /ID# 221658 | Ann Arbor | Michigan | 48109-5000 | — |
| Minnesota Oncology Hematology /ID# 227357 | Edina | Minnesota | 55435 | — |
| MidAmerica Division, Inc. /ID# 221743 | Kansas City | Missouri | 64132 | — |
| Hackensack Univ Med Ctr /ID# 221654 | Hackensack | New Jersey | 07601 | — |
| Northwell Health - Monter Cancer Center /ID# 222996 | Lake Success | New York | 11042 | — |
| Weill Cornell Medical College /ID# 220933 | New York | New York | 10065 | — |
| Gabrail Cancer Center Research /ID# 230488 | Canton | Ohio | 44718 | — |
| Oncology Hematology Care, Inc. /ID# 222556 | Cincinnati | Ohio | 45236-2725 | — |
| The Ohio State University /ID# 221584 | Columbus | Ohio | 43210 | — |
| UPMC Hillman Cancer Ctr /ID# 218134 | Pittsburgh | Pennsylvania | 15232 | — |
| Thompson Cancer Survival Ctr /ID# 231689 | Knoxville | Tennessee | 37916 | — |
| University of Texas MD Anderson Cancer Center /ID# 217994 | Houston | Texas | 77030 | — |
| Texas Oncology - Northeast Texas /ID# 241813 | Tyler | Texas | 75702 | — |
| Utah Cancer Specialists Salt Lake Clinic /ID# 221961 | Salt Lake City | Utah | 84106 | — |
| University of Utah /ID# 221009 | Salt Lake City | Utah | 84112-5500 | — |
| Virginia Cancer Specialists - Fairfax /ID# 242682 | Fairfax | Virginia | 22031 | — |
| VA Puget Sound Health Care System /ID# 231691 | Seattle | Washington | 98108-1597 | — |
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 159 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04472598, 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 Mar 23, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04472598 live on ClinicalTrials.gov.