Trial · NCT01259856
Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
NCT01259856, Phase 3, Completed, Ronald Hoffman; results first posted 2018-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET). Trials, record NCT01259856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01259856
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
- NCT number
- NCT01259856
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 168 participants, actual
- Lead sponsor
- Ronald Hoffman
- Conditions
- High Risk Polycythemia Vera, High Risk Essential Thrombocythemia
- Interventions
- PEGASYS, Hydroxyurea, Aspirin
- First posted
- 2010-12-14
- Last updated
- 2019-04-30
- Results first posted
- 2018-07-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Remission (CR) | 12 months | Number of participants with Complete Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Complete remission means no evidence of disease. |
| Primary | Number of Participants With Partial Remission (PR) | 12 months | Number of participants with Partial Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Partial Remission means decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. |
| Secondary | Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events | 4 years | Number of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea). |
| Secondary | Change in the Total Symptom Score (TSS) | baseline and 12 months | Change in the Total Symptom Score which assessed improvement in disease symptoms measured by the change in TSS from the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) instrument being used in this study from baseline to 12 months. This 19 item instrument includes the previously validated 9 item brief fatigue inventory (BFI), symptoms related to splenomegaly, inactivity, cough, night sweats, pruritus, bone pains, fevers, weight loss, and an overall quality of life assessment. Each item is scored from 0-10 with full scale from 0-190, with higher scores mean worse symptoms. |
| Secondary | JAK2 Allele Burden | 4 years | To compare the impact of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) on key biomarkers of the disease(s) by measuring the JAK2 allele burden. |
| Secondary | Allele Burden | 4 years | The impact of PEGASYS on JAK2 will be measured by the allele burden; hematopoietic cell clonality will be measured by whether patients with clonal disease return to polyclonal; bone marrow histopathology will be measured by going from abnormal to normal; cytogenetic abnormalities will be measured by seeing if the cytogenetics go from abnormal to normal.To compare the impact of therapy on JAK2-V617F (JAK2), CALR, hematopoietic cell clonality in platelets and granulocytes in females, bone marrow histopathology, and cytogenetic abnormalities. |
| Secondary | Number of Participants With Progression of Disease or Death | 4 years | Survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy To estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) by capturing the rate of progression to a more advanced myeloid malignancy. |
| Secondary | Number of Participants With Major Cardiovascular Events After Therapy | 4 years |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Remission (CR) | 12 months | there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Partial Remission (PR) | 12 months | there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events | 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in the Total Symptom Score (TSS) | baseline and 12 months | score on a scale | MEAN | |
| SECONDARY | JAK2 Allele Burden | 4 years | data not collected | ||
| SECONDARY | Allele Burden | 4 years | data not collected | ||
| SECONDARY | Number of Participants With Progression of Disease or Death | 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Major Cardiovascular Events After Therapy | 4 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Remission (CR) | PEGASYS | Essential Thrombocythemia | 17 | Participants | |
| Number of Participants With Complete Remission (CR) | Hydroxyurea | Essential Thrombocythemia | 19 | Participants | |
| Number of Participants With Complete Remission (CR) | PEGASYS | Polycythemia Vera | 12 | Participants | |
| Number of Participants With Complete Remission (CR) | Hydroxyurea | Polycythemia Vera | 13 | Participants | |
| Number of Participants With Partial Remission (PR) | PEGASYS | Essential Thrombocythemia | 10 | Participants | |
| Number of Participants With Partial Remission (PR) | Hydroxyurea | Essential Thrombocythemia | 11 | Participants | |
| Number of Participants With Partial Remission (PR) | PEGASYS | Polycythemia Vera | 25 | Participants | |
| Number of Participants With Partial Remission (PR) | Hydroxyurea | Polycythemia Vera | 17 | Participants | |
| Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events | PEGASYS | Grade 3 Hematological event | 3 | Participants | |
| Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events | Hydroxyurea | Grade 3 Hematological event | 2 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PEGASYS | 82 | |
| Overall Study | STARTED | Hydroxyurea | 86 | |
| Overall Study | COMPLETED | PEGASYS | 13 | |
| Overall Study | COMPLETED | Hydroxyurea | 12 | |
| Overall Study | NOT COMPLETED | PEGASYS | 69 | |
| Overall Study | NOT COMPLETED | Hydroxyurea | 74 |
Source ClinicalTrials.gov
Adverse events436
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 | Abdominal Distenstion | Gastrointestinal disorders | PEGASYS | 0 | 82 | |
| other | Abdominal Distenstion | Gastrointestinal disorders | Hydroxyurea | 1 | 86 | |
| other | Abdominal hernias and other abdominal wall conditions | Gastrointestinal disorders | PEGASYS | 0 | 82 | |
| other | Abdominal hernias and other abdominal wall conditions | Gastrointestinal disorders | Hydroxyurea | 1 | 86 | |
| other | Abdominal Pain | Gastrointestinal disorders | PEGASYS | 0 | 82 | |
| other | Abdominal Pain | Gastrointestinal disorders | Hydroxyurea | 1 | 86 | |
| other | Administration site reactions | General disorders | PEGASYS | 15 | 82 | |
| other | Administration site reactions | General disorders | Hydroxyurea | 0 | 86 | |
| other | Administration site reactions | Injury, poisoning and procedural complications | PEGASYS | 1 | 82 | |
| other | Administration site reactions | Injury, poisoning and procedural complications | Hydroxyurea | 0 | 86 |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEGASYS | 0 | 82 |
| Total, all-cause mortality | Hydroxyurea | 1 | 86 |
| Total, other adverse events | PEGASYS | 79 | 82 |
| Total, other adverse events | Hydroxyurea | 76 | 86 |
| Total, serious adverse events | PEGASYS | 14 | 82 |
| Total, serious adverse events | Hydroxyurea | 4 | 86 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA108671 | Myeloproliferative Neoplasms-Research Consortium | HOFFMAN, RONALD | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2006 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PEGASYS vs Hydroxyurea: Number of Participants With Major Cardiovascular Events After Therapy | Trial comparisons |
| PEGASYS vs Hydroxyurea: deaths from any cause | Trial comparisons |
| PEGASYS vs Hydroxyurea: 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/NCT01259856
GET https://conductscience.org/api/trials/v1/NCT01259856/results?page=2