Trial · NCT01758588
Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis
NCT01758588, Phase 2, Terminated, Weill Medical College of Cornell University; results first posted 2018-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis. Trials, record NCT01758588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01758588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis
- NCT number
- NCT01758588
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Myelofibrosis
- Interventions
- Peginterferon alfa-2a
- First posted
- 2013-01-01
- Last updated
- 2018-07-24
- Results first posted
- 2018-07-24
- Limitations and caveats
- Due to early termination of the trial, there is not enough data to evaluate All-Cause Mortality. Therefore, it is reported that 0 subjects were affected out of 8 subjects at risk.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Improvement | One year | Clinical improvement (CI) Requires one of the following in the absence of both disease progression (as outlined below) and Complete Response (CR)/Partial Response (PR) assignment (CI response is validated only if it lasts for no fewer than 8 weeks) i. A minimum 20-g/L increase in hemoglobin level or becoming transfusion independent (applicable only for patients with baseline hemoglobin level of less than 100 g/L). ii. Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable. iii. A minimum 100% increase in platelet count and an absolute platelet count of at least 50 000 109/L (applicable only for patients with baseline platelet count below 50 109/L). iv. A minimum 100% increase in Absolute Neutrophil Count (ANC) and an ANC of at least 0.5 109/L (applicable only for patients with baseline absolute neutrophil count below 1 109/L). |
| Secondary | Progression Free Survival | Week 21 | Progression free survival is the measure of subject survival in the absence of disease progression. Disease progression is defined as progression to the next higher International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Dynamic International Prognostic Scoring System (DIPSS) stage from diagnosis. The IWG-MRT DIPSS stratifies primary myelofibrosis (PMF) into four risk categories (low, intermediate 1, intermediate 2, and high risk), based on 5 clinical factors; Age\>65, Hemoglobin \<10gm/dL, white blood cell (WBC)\>25,000/uL, peripheral blasts\>1%, and constitutional symptoms. Progression free survival will be assessed at 21 weeks from time of study entry. |
| Secondary | Overall Survival | Week 21 | Overall survival measures subject survival regardless of disease progression. Overall survival will be assessed at 21 weeks from time of study entry. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Improvement | One year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival | Week 21 | Analysis population includes subjects who were evaluable at 21 weeks from time of study entry. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Week 21 | Due to early termination of the trial, there is not enough data to evaluate overall survival. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Improvement | Treatment Arm | Achieved Clinical Improvement (CI) | 1 | Participants | |
| Clinical Improvement | Observation Arm | Achieved Clinical Improvement (CI) | 0 | Participants | |
| Clinical Improvement | Treatment Arm | Did not achieve Clinical Improvement (CI) | 2 | Participants | |
| Clinical Improvement | Observation Arm | Did not achieve Clinical Improvement (CI) | 2 | Participants | |
| Clinical Improvement | Treatment Arm | Not evaluable | 2 | Participants | |
| Clinical Improvement | Observation Arm | Not evaluable | 1 | Participants | |
| Progression Free Survival | Treatment Arm | Disease did not progress | 2 | Participants | |
| Progression Free Survival | Observation Arm | Disease did not progress | 3 | Participants | |
| Progression Free Survival | Treatment Arm | Disease progressed | 2 | Participants | |
| Progression Free Survival | Observation Arm | Disease progressed | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm | 5 | |
| Overall Study | STARTED | Observation Arm | 3 | |
| Overall Study | COMPLETED | Treatment Arm | 5 | |
| Overall Study | COMPLETED | Observation Arm | 3 | |
| Overall Study | NOT COMPLETED | Treatment Arm | 0 | |
| Overall Study | NOT COMPLETED | Observation Arm | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Depression | Psychiatric disorders | Treatment Arm | 1 | 5 | 1 |
| other | Depression | Psychiatric disorders | Observation Arm | 0 | 3 | 0 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Treatment Arm | 1 | 5 | 1 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Observation Arm | 0 | 3 | 0 |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Treatment Arm | 1 | 5 | 1 |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Observation Arm | 0 | 3 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm | 0 | 5 |
| Total, all-cause mortality | Observation Arm | 0 | 3 |
| Total, other adverse events | Treatment Arm | 1 | 5 |
| Total, other adverse events | Observation Arm | 0 | 3 |
| Total, serious adverse events | Treatment Arm | 2 | 5 |
| Total, serious adverse events | Observation Arm | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Arm vs Observation Arm: deaths from any cause | Trial comparisons |
| Treatment Arm vs Observation Arm: serious adverse events | Trial comparisons |
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/NCT01758588
GET https://conductscience.org/api/trials/v1/NCT01758588/registered