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

NCT ID: NCT02736721

Last Updated: 2016-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myelogenous Leukemia, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peginterferon alfa-2a

Participants will receive peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator.

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Pegasys

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Freiburg im Breisgau, , Germany

Site Status

Mainz, , Germany

Site Status

Mannheim, , Germany

Site Status

Marburg, , Germany

Site Status

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML17395

Identifier Type: -

Identifier Source: org_study_id

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