Expanded Access Study With Peginterferon Alfa-2a (Pegasys) in Participants With Chronic Myelogenous Leukemia (CML)

Myelogenous Leukemia, Chronic Clinical Trial

Official title:

Multicenter Open Label Expanded Access-Program of Pegylated Interferon Alfa-2a (Pegasys) in Patients With Chronic Myelogenous Leukemia (CML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736721
• Other study ID #: ML17395
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2016
• Last updated: April 18, 2016
• Start date: September 2003
• Est. completion date: November 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Myelogenous Leukemia, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Peginterferon alfa-2a in doses between 90 and 450 mcg, will be administered subcutaneously once weekly until medically indicated as judged by the treating investigator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Hematologic Response Based on White Blood Cell Count, Platelet Count and Signs and Symptoms of Disease		up to approximately 7 years	No
Primary	Time to Loss of Previous Hematologic Response Based on White Blood Cell Count, Platelet Count and Signs and Symptoms of Disease		up to approximately 7 years	No
Primary	Number of Participants With Major Cytogenetic Response Based on Philadelphia Chromosome Positive Bone Marrow Cells		up to approximately 7 years	No
Primary	Time to Loss of Cytogenetic Response Based on Philadelphia Chromosome Positive Bone Marrow Cells		up to approximately 7 years	No
Primary	Number of Participants With Molecular Response Based on Breakpoint Cluster Region-Abelson (BCR-ABL)/ABL Ratio Determined From Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)		up to approximately 7 years	No
Primary	Time to Loss of Molecular Response Based on BCR-ABL/ABL Ratio Determined From Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)		up to approximately 7 years	No
Secondary	Number of Participants With Adverse Events		up to approximately 7 years	No