Trial · NCT03222609
A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
NCT03222609, Phase 2, Completed, AbbVie; results first posted 2025-03-12
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis. Trials, record NCT03222609. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03222609
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
- NCT number
- NCT03222609
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 191 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Myelofibrosis (MF)
- Interventions
- Ruxolitinib, Navitoclax
- First posted
- 2017-07-19
- Last updated
- 2026-01-20
- Other registries' IDs
- eudract:2017-001398-17
- Results first posted
- 2025-03-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Baseline, Week 24 | Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT). |
| Secondary | Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | Baseline, Week 24 | TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0. Participants complete a symptom diary and rate the following seven MF symptoms: fatigue, night sweats, abdominal discomfort, pruritus, pain under the ribs on the left side, early satiety, and bone pain daily using a scale from 0 (absent) to 10 (worst imaginable), and the scores are averaged over 7 days, with a minimum of 4 days required to calculate the average score. Participants for whom a valid average score cannot be calculated either at baseline or post-baseline are considered non-responders. The TSS reflects the sum of the scores of these symptoms, for a maximum possible score of 70 (i.e., most severe symptom experience). |
| Secondary | Percentage of Participants Achieving Anemia Response | Up to 254 weeks | For a participant who is transfusion independent (TI) at Baseline with hemoglobin value \< 10 g/dL, anemia response is achieved if the post-Baseline hemoglobin level increases by ≥2 g/dL without receiving packed red blood cells (PRBC) transfusion (for any reason) within 2 weeks and without any erythropoietin or mimetics within the last 4 weeks prior to the increase in hemoglobin level by ≥2g/dL was observed. Hemoglobin values more than 30 days after the last dose of study treatment or after the start of post-study treatment or disease progression, whichever is earlier, will not be considered in the analysis of anemia response. For a participant who is transfusion dependent (TD) at Baseline, anemia response is defined as a period of at least 12 consecutive weeks without PRBC transfusion at any time after the first dose of study drug and on or prior to 30 days post last dose of study drug, the start of post-study treatment, disease progression or death, whichever occurs earlier. |
| Secondary | Percentage of Participants With ≥ 1 Grade Reduction From Baseline in Fibrosis Grade At Any Time | Up to 254 weeks | Bone marrow grading is assessed according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. |
| Secondary | Time to First Reduction in Fibrosis Grade | Up to 254 weeks | Grade of bone marrow fibrosis was assessed by investigators according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. The time to first achieving a reduction of at least 1 grade in bone marrow fibrosis from Baseline was summarized. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Baseline, Week 24 | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | Baseline, Week 24 | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Anemia Response | Up to 254 weeks | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax; participants who were Baseline transfusion independent with baseline hemoglobin of ≥10 g/dL were excluded from the analysis since they were not evaluable for anemia response. Missing post-Baseline anemia response in Full Analysis Set applicable to evaluation of anemia response are considered as non-responders of anemia response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 1 Grade Reduction From Baseline in Fibrosis Grade At Any Time | Up to 254 weeks | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax; participants with missing bone marrow fibrosis grade (either Baseline or post-Baseline) or those with bone marrow fibrosis Grade 0 at Baseline were excluded from the analysis for the change in bone marrow fibrosis grade | percentage of participants | NUMBER |
| SECONDARY | Time to First Reduction in Fibrosis Grade | Up to 254 weeks | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax; participants with Baseline bone marrow fibrosis grade \>0 and post-Baseline bone marrow fibrosis grade are included in the analysis | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Navitoclax + Ruxolitinib (Cohort 1a) | 26.47 | 95% Confidence Interval 12.88 to 44.36 | percentage of participants | |
| Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Navitoclax + Ruxolitinib (Cohort 1b) | 21.98 | 95% Confidence Interval 13.97 to 31.88 | percentage of participants | |
| Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Navitoclax (Cohort 2) | 11.76 | 95% Confidence Interval 3.30 to 27.45 | percentage of participants | |
| Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Navitoclax + Ruxolitinib (Cohort 3) | 62.50 | 95% Confidence Interval 43.69 to 78.90 | percentage of participants | |
| Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | Navitoclax + Ruxolitinib (Cohort 1a) | 20.59 | 95% Confidence Interval 8.70 to 37.90 | percentage of participants | |
| Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | Navitoclax + Ruxolitinib (Cohort 1b) | 25.27 | 95% Confidence Interval 16.75 to 35.47 | percentage of participants | |
| Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | Navitoclax (Cohort 2) | 8.82 | 95% Confidence Interval 1.86 to 23.68 | percentage of participants | |
| Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | Navitoclax + Ruxolitinib (Cohort 3) | 34.38 | 95% Confidence Interval 18.57 to 53.19 | percentage of participants | |
| Percentage of Participants Achieving Anemia Response | Navitoclax + Ruxolitinib (Cohort 1a) | Baseline transfusion independent with Baseline HGB <10 g/dL | 28.57 | 95% Confidence Interval 3.67 to 70.96 | percentage of participants |
| Percentage of Participants Achieving Anemia Response | Navitoclax + Ruxolitinib (Cohort 1b) | Baseline transfusion independent with Baseline HGB <10 g/dL | 23.68 | 95% Confidence Interval 11.44 to 40.24 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Navitoclax + Ruxolitinib (Cohort 1a) | 34 | |
| Overall Study | STARTED | Navitoclax + Ruxolitinib (Cohort 1b) | 91 | |
| Overall Study | STARTED | Navitoclax (Cohort 2) | 34 | |
| Overall Study | STARTED | Navitoclax + Ruxolitinib (Cohort 3) | 32 | |
| Overall Study | COMPLETED | Navitoclax + Ruxolitinib (Cohort 1a) | 0 | |
| Overall Study | COMPLETED | Navitoclax + Ruxolitinib (Cohort 1b) | 0 | |
| Overall Study | COMPLETED | Navitoclax (Cohort 2) | 0 | |
| Overall Study | COMPLETED | Navitoclax + Ruxolitinib (Cohort 3) | 0 | |
| Overall Study | NOT COMPLETED | Navitoclax + Ruxolitinib (Cohort 1a) | 34 | |
| Overall Study | NOT COMPLETED | Navitoclax + Ruxolitinib (Cohort 1b) | 91 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,012
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 1a) | 11 | 34 | 23 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 1b) | 47 | 91 | 81 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax (Cohort 2) | 13 | 34 | 26 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 3) | 21 | 32 | 51 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 1a) | 0 | 34 | 0 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 1b) | 0 | 91 | 0 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | Navitoclax (Cohort 2) | 0 | 34 | 0 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 3) | 2 | 32 | 2 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 1a) | 2 | 34 | 8 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Navitoclax + Ruxolitinib (Cohort 1b) | 5 | 91 | 7 |
1 to 10 of 1,012Source ClinicalTrials.gov
See all 1,012 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Navitoclax + Ruxolitinib (Cohort 1a) | 20 | 34 |
| Total, all-cause mortality | Navitoclax + Ruxolitinib (Cohort 1b) | 39 | 91 |
| Total, all-cause mortality | Navitoclax (Cohort 2) | 18 | 34 |
| Total, all-cause mortality | Navitoclax + Ruxolitinib (Cohort 3) | 10 | 32 |
| Total, other adverse events | Navitoclax + Ruxolitinib (Cohort 1a) | 34 | 34 |
| Total, other adverse events | Navitoclax + Ruxolitinib (Cohort 1b) | 91 | 91 |
| Total, other adverse events | Navitoclax (Cohort 2) | 34 | 34 |
| Total, other adverse events | Navitoclax + Ruxolitinib (Cohort 3) | 32 | 32 |
| Total, serious adverse events | Navitoclax + Ruxolitinib (Cohort 1a) | 21 | 34 |
| Total, serious adverse events | Navitoclax + Ruxolitinib (Cohort 1b) | 35 | 91 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT03222609
GET https://conductscience.org/api/trials/v1/NCT03222609/results?page=2