Trial · NCT04468984
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, Phase 3, Active not recruiting, AbbVie
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT04468984. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04468984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04468984
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 330 participants, estimated
- Lead sponsor
- AbbVie
- Conditions
- Myelofibrosis (MF)
- Interventions
- Navitoclax, Ruxolitinib, Best Available Therapy (BAT)
- First posted
- 2020-07-13
- Last updated
- 2026-01-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) | At Week 24 | Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria. |
| Secondary | Arms A and B: Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS) | Baseline (Week 0) Up to Week 24 | Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. |
| Secondary | Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time | Baseline (Week 0) Up to Week 97 | Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria. |
| Secondary | Arms A and B: Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis | Baseline (Week 0) Up to Week 97 | Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed. |
| Secondary | Arms A and B: Percentage of Participants with Anemia Response | Baseline (Week 0) Up to Week 97 | Anemia response per International Working Group (IWG) criteria will be assessed. |
| Secondary | Arms A and B: Percentage of Participants with Overall Survival | Last Visit Up to 5 Years | Overall survival is defined as the time from start of study to the date of death from any cause. |
| Secondary | Arms A and B: Percentage of Participants with Leukemia-free Survival | Last Visit Up to 5 Years | Leukemia free survival is the time from start of study to the date of development of leukemia. |
| Secondary | Arms A and B: Percentage of Participants with Change in Fatigue | Baseline (Week 0) Up to Week 24 | Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a. |
| Secondary | Arms A and B: Time to Deterioration of Physical Functioning | Baseline (Week 0) Up to Week 97 | Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death. |
| Secondary | Arms A and B: Percentage of Participants with at Least 50% Reduction in TSS | Baseline (Week 0) Up to Week 97 | At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42842696 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04468984
GET https://conductscience.org/api/trials/v1/NCT04468984/registered