Trial · NCT03547154
Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)
NCT03547154, Phase 2, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2019-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026). Trials, record NCT03547154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03547154
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)
- NCT number
- NCT03547154
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 344 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Myelogenous Leukemia
- Interventions
- Pegylated interferon alfa-2b, Interferon alfa-2b
- First posted
- 2018-06-06
- Last updated
- 2019-08-12
- Results first posted
- 2019-08-12
- Limitations and caveats
- AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 10.0
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | Up to 12 months | Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses. |
| Secondary | Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months | 6 months | Cytogenetic response (CR) at 6 months, as at 12 months, was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. The determination of CR at 6 months was based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete (0%), Partial (1-34%), Minor (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses. |
| Secondary | Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months | 6 months | Hematologic response at 6 months was assessed, while the hematologic response was measured at 3, 6, 9 and 12 months during the first year of study treatment. To be considered a hematologic responder a participant must have met all of the following criteria for a minimum of 28 days: WBC count \<10,000/μL; platelet count \<450,000/L; normal differential count in peripheral blood (manual differential count); no palpable spleen. Participants achieving a complete hematologic response at 3 months had the cytogenetic response evaluated at 3 months as well. Participants who achieved a complete hematologic response by 6 months continued treatment for another 6 months. Participants who failed to achieve a complete hematologic response after 6 months of treatment were considered treatment failures, and further treatment for this group was at the discretion of the treating physician. Participants may have continued to receive their assigned study medication for an additional 6 months. |
| Secondary | Number of Participants With Overall Survival | Up to 2 years (24 months), and beyond | Participants were followed for survival; those who did not achieve a major cytogenetic response were discontinued from the study. For participants who completed 1 year of study treatment and continued to Year 2 and beyond, survival and disease progression every 3 months were assessed, and serious adverse events (SAEs) were reported. Participants were followed until resolution of any drug-related nonserious adverse event, and any SAE occurring while on the study or within 30 days of last dose of study drug. Participant death during survival follow-up was reported to the drug safety unit of the Sponsor. Each participant (whether discontinued or still on treatment) was followed every 3 months for survival and disease progression information. Overall survival was analyzed using the log-rank statistic, and the hazard ratio (HR) and 95% confidence interval (CI) for the HR were obtained using Cox's proportional hazards model. |
Source ClinicalTrials.gov
Outcomes4
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 Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | Up to 12 months | All randomized participants analyzed on an intent-to-treat basis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months | 6 months | All randomized participants who received at least one dose of assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months | 6 months | All randomized participants who received at least one dose of assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Survival | Up to 2 years (24 months), and beyond | All randomized participants who received at least one dose of assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | INTRON A (Interferon Alfa-2b) | Complete Response | 13 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | PEG Intron (Pegylated Interferon Alfa-2b) | Complete Response | 13 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | INTRON A (Interferon Alfa-2b) | Partial Response | 35 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | PEG Intron (Pegylated Interferon Alfa-2b) | Partial Response | 26 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | INTRON A (Interferon Alfa-2b) | Minor Respnse | 31 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | PEG Intron (Pegylated Interferon Alfa-2b) | Minor Respnse | 24 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | INTRON A (Interferon Alfa-2b) | No Respnse | 15 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | PEG Intron (Pegylated Interferon Alfa-2b) | No Respnse | 25 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | INTRON A (Interferon Alfa-2b) | Discontinued or No Hematologic CR at Month 6 | 78 | Participants | |
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | PEG Intron (Pegylated Interferon Alfa-2b) | Discontinued or No Hematologic CR at Month 6 | 83 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | INTRON A (Interferon Alfa-2b) | 173 | |
| Overall Study | STARTED | PEG Intron (Pegylated Interferon Alfa-2b) | 171 | |
| Overall Study | COMPLETED | INTRON A (Interferon Alfa-2b) | 50 | |
| Overall Study | COMPLETED | PEG Intron (Pegylated Interferon Alfa-2b) | 55 | |
| Overall Study | NOT COMPLETED | INTRON A (Interferon Alfa-2b) | 123 | |
| Overall Study | NOT COMPLETED | PEG Intron (Pegylated Interferon Alfa-2b) | 116 |
Source ClinicalTrials.gov
Adverse events492
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 | INTRON A, 5 MIU/m^2 Daily | 8 | 173 | 10 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG-Intron, 6.0 mcg/kg Weekly | 21 | 171 | 43 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | INTRON A, 5 MIU/m^2 Daily | 19 | 173 | 32 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | PEG-Intron, 6.0 mcg/kg Weekly | 19 | 171 | 38 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | INTRON A, 5 MIU/m^2 Daily | 6 | 173 | 7 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | PEG-Intron, 6.0 mcg/kg Weekly | 13 | 171 | 13 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | INTRON A, 5 MIU/m^2 Daily | 9 | 173 | 11 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | PEG-Intron, 6.0 mcg/kg Weekly | 12 | 171 | 29 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | INTRON A, 5 MIU/m^2 Daily | 35 | 173 | 65 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | PEG-Intron, 6.0 mcg/kg Weekly | 34 | 171 | 74 |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INTRON A, 5 MIU/m^2 Daily | 15 | 173 |
| Total, all-cause mortality | PEG-Intron, 6.0 mcg/kg Weekly | 17 | 171 |
| Total, other adverse events | INTRON A, 5 MIU/m^2 Daily | 170 | 173 |
| Total, other adverse events | PEG-Intron, 6.0 mcg/kg Weekly | 168 | 171 |
| Total, serious adverse events | INTRON A, 5 MIU/m^2 Daily | 62 | 173 |
| Total, serious adverse events | PEG-Intron, 6.0 mcg/kg Weekly | 74 | 171 |
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 |
|---|---|
| INTRON A, 5 MIU/m^2 Daily vs PEG-Intron, 6.0 mcg/kg Weekly: deaths from any cause | Trial comparisons |
| INTRON A, 5 MIU/m^2 Daily vs PEG-Intron, 6.0 mcg/kg Weekly: 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/NCT03547154
GET https://conductscience.org/api/trials/v1/NCT03547154/results?page=2