Phase 3
N=41
Expanded Access Study With Peginterferon Alfa-2a (Pegasys) in Participants With Chronic Myelogenous Leukemia (CML)
Myelogenous Leukemia, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02736721 ↗Enrolled (actual)
41
Serious AEs
31.7%
Results posted
Aug 2016
Primary outcome: Primary: Number of Participants With Complete Hematologic Response — 40 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Peginterferon alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Hematologic Response |
40 | — |
| PRIMARY Time to Loss of Previous Hematologic Response |
NA | — |
| PRIMARY Number of Participants With Major Cytogenetic Response (CyR) |
40 | — |
| PRIMARY Time to Loss of Previous CyR |
NA | — |
| PRIMARY Number of Participants With Molecular Response (MR) |
38 | — |
| PRIMARY Time to Loss of Previous MR |
NA | — |
Summary
This study will evaluate the efficacy, safety and tolerability of long-term use of peginterferon alfa-2a in participants with CML who have previously participated in peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and treating physician has decided to continue treatment with peginterferon alfa-2a within the frame of another clinical study.
Eligibility Criteria
Inclusion Criteria
- Participants with CML
- Previous participation in studies: ML16544, NO16006 or ML17228; for which the treating physician recommends a continuation of the study drug according to defined minimal criteria
Exclusion Criteria
- Major protocol violator in the participated study prior to participation in this study
Data sourced from ClinicalTrials.gov (NCT02736721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.