Trial · NCT00934544
Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
NCT00934544, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial. Trials, record NCT00934544. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00934544
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
- NCT number
- NCT00934544
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 219 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Myelofibrosis
- Interventions
- Ruxolitinib, Best Available Therapy (BAT)
- First posted
- 2009-07-08
- Last updated
- 2019-08-19
- Other registries' IDs
- eudract:2009-009858-24
- Results first posted
- 2012-05-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 | Baseline, Week 48 | The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group. |
| Secondary | Duration of Maintenance of Spleen Volume Reduction (Median) | Baseline, up to Year 5 | DoMSR is defined as the interval between the first spleen volume measurement that is \>=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a \>25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume. |
| Secondary | Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Baseline, up to Year 5 | This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume. |
| Secondary | Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24 | Baseline, Week 24 | The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group. |
| Secondary | Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis) | Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume | This is defined as the interval between randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume |
| Secondary | Progression-free Survival (PFS) | Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death | Median of time progression free survival (95% CI), years |
| Secondary | Leukemia-free Survival (LFS) | Time from randomization and earliest of either leukemia or death | Time from randomization and earliest of either (1) date of bone marrow blast count of 20% or greater; (2) date of first peripheral blast count of 20% or greater that was subsequently confirmed to sustain for at least 8 weeks; (3) date of death from any cause |
| Secondary | Overall Survival (OS) | From randomization until death from any cause | Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first. OS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints |
| Secondary | Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis) | 48 weeks | This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used. Fibrosis grades: 0 Scattered linear reticulin with no intersections corresponding to normal bone marrow ; 1 Loose network of reticulin with many intersections, especially in perivascular areas; 2 Diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; 3 Diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis |
| Secondary | Bone Marrow Histomorphology | Baseline, once a year | Shift table from baseline to last available postbaseline fibrosis grade by treatment The grade gives an indication of the activity or amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is assigned a number based on the degree of inflammation, which is usually scored from 0-4 with 0 being no activity and 3 or 4 considered severe activity |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 at Least 35% Reduction in Spleen Volume From Baseline at Week 48 | Baseline, Week 48 | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Maintenance of Spleen Volume Reduction (Median) | Baseline, up to Year 5 | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization. | years | MEDIAN |
| SECONDARY | Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Baseline, up to Year 5 | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization. | probability of response | NUMBER |
| SECONDARY | Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24 | Baseline, Week 24 | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis) | Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume | Full analysis set (FAS) | probability of response | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization. | years | MEDIAN |
| SECONDARY | Leukemia-free Survival (LFS) | Time from randomization and earliest of either leukemia or death | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization. | Years | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until death from any cause | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization. | Years | MEDIAN |
| SECONDARY | Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis) | 48 weeks | Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. | Percentage of participants | NUMBER |
| SECONDARY | Bone Marrow Histomorphology | Baseline, once a year | Full Analysis Set (FAS)~Numbers of Participants Analyzed reflect only those participants who were randomized to either Ruxolitinib or Best Available Therapy and do not count those participants who could have crossed over to Ruxolitinib | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group110
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 at Least 35% Reduction in Spleen Volume From Baseline at Week 48 | Ruxolitinib | 28.5 | Percentage of Participants | ||
| Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 | Best Available Therapy (BAT) | 0 | Percentage of Participants | ||
| Duration of Maintenance of Spleen Volume Reduction (Median) | Ruxolitinib | 3.22 | 95% Confidence Interval 1.65 to NA | years | |
| Duration of Maintenance of Spleen Volume Reduction (Median) | Best Available Therapy (BAT) | NA | 95% Confidence Interval NA to NA | years | |
| Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Ruxolitinib | 1.0 year | 0.72 | 95% Confidence Interval .60 to .81 | probability of response |
| Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Best Available Therapy (BAT) | 1.0 year | NA | 95% Confidence Interval NA to NA | probability of response |
| Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Ruxolitinib | 1.5 years | 0.67 | 95% Confidence Interval 0.55 to 0.77 | probability of response |
| Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Best Available Therapy (BAT) | 1.5 years | NA | 95% Confidence Interval NA to NA | probability of response |
| Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Ruxolitinib | 2.0 years | 0.63 | 95% Confidence Interval 0.50 to 0.73 | probability of response |
| Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) | Best Available Therapy (BAT) | 2.0 years | NA | 95% Confidence Interval NA to NA | probability of response |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Endpoint Analysis (Interim) | STARTED | Ruxolitinib | 146 | |
| Primary Endpoint Analysis (Interim) | STARTED | Best Available Therapy (BAT) | 73 | |
| Primary Endpoint Analysis (Interim) | STARTED | Ruxolitinib After BAT (Cross-over) | 0 | |
| Primary Endpoint Analysis (Interim) | COMPLETED | Ruxolitinib | 91 | |
| Primary Endpoint Analysis (Interim) | COMPLETED | Best Available Therapy (BAT) | 31 | |
| Primary Endpoint Analysis (Interim) | COMPLETED | Ruxolitinib After BAT (Cross-over) | 0 | |
| Primary Endpoint Analysis (Interim) | NOT COMPLETED | Ruxolitinib | 55 | |
| Primary Endpoint Analysis (Interim) | NOT COMPLETED | Best Available Therapy (BAT) | 42 | |
| Primary Endpoint Analysis (Interim) | NOT COMPLETED | Ruxolitinib After BAT (Cross-over) | 0 | |
| Overall Disposition at 5 Year Follow-up | STARTED | Ruxolitinib | 146 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,300
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 | Ruxolitinib Randomized | 61 | 146 | |
| other | Anaemia | Blood and lymphatic system disorders | Ruxolitinib Randomized + Extension Phase | 71 | 146 | |
| other | Anaemia | Blood and lymphatic system disorders | BAT Randomized | 8 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Ruxolitinib Cross-over | 19 | 45 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Ruxolitinib Randomized | 7 | 146 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Ruxolitinib Randomized + Extension Phase | 8 | 146 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BAT Randomized | 0 | 73 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Ruxolitinib Cross-over | 2 | 45 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib Randomized | 67 | 146 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib Randomized + Extension Phase | 77 | 146 |
1 to 10 of 1,300Source ClinicalTrials.gov
See all 1,300 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib Randomized | ||
| Total, all-cause mortality | Ruxolitinib Randomized + Extension Phase | ||
| Total, all-cause mortality | BAT Randomized | ||
| Total, all-cause mortality | Ruxolitinib Cross-over | ||
| Total, other adverse events | Ruxolitinib Randomized | 145 | 146 |
| Total, other adverse events | Ruxolitinib Randomized + Extension Phase | 145 | 146 |
| Total, other adverse events | BAT Randomized | 64 | 73 |
| Total, other adverse events | Ruxolitinib Cross-over | 42 | 45 |
| Total, serious adverse events | Ruxolitinib Randomized | 51 | 146 |
| Total, serious adverse events | Ruxolitinib Randomized + Extension Phase | 85 | 146 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
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/NCT00934544
GET https://conductscience.org/api/trials/v1/NCT00934544/results?page=2