Skip to main content
OpenTrials
Completed

NCT Number: NCT02736721

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelogenous Leukemia, Chronic Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Freiburg im Breisgau, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a

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.

Other names: Pegasys

Primary outcomes

  1. Number of Participants With Complete Hematologic Response

    Time frame: Up to approximately 7 years

    Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to less than (<) 10*10^9 per liter (/L) with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.

  2. Time to Loss of Previous Hematologic Response

    Time frame: Up to approximately 7 years

    Time to loss of previous hematologic response was defined as the interval between the first day of treatment in the study and the first day of loss of previous hematologic response during elapsed time of study. Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to <10*10^9/L with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.

  3. Number of Participants With Major Cytogenetic Response (CyR)

    Time frame: Up to approximately 7 years

    CyR was based on the prevalence of Philadelphia chromosome-positive (Ph+) bone marrow cells in metaphase determined from reverse transcriptase polymerase chain reaction (RT-PCR). Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34 percent (%) of bone marrow cells were Ph+.

  4. Time to Loss of Previous CyR

    Time frame: Up to approximately 7 years

    Time to loss of previous CyR was defined as the interval between the first day of treatment in the study and the first day of loss of previous CyR. CyR is based on the prevalence of Ph+ bone marrow cells in metaphase. Major CyR was categorized as either CCyR or PCyR. CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34% of bone marrow cells were Ph+.

  5. Number of Participants With Molecular Response (MR)

    Time frame: Up to approximately 7 years

    MR was assessed using breakpoint cluster region - Abelson (BCR-ABL) proto-oncogene transcript levels measured by RT-PCR from peripheral blood. Number of participants with BCR-ABL/ABL ratio less than or equal to 10 (%) was reported.

  6. Time to Loss of Previous MR

    Time frame: Up to approximately 7 years

    Time to loss of previous MR was defined as the interval between the first day of treatment in the study and the first day of loss of previous MR. MR was assessed using BCR-ABL transcript levels measured by RT-PCR from peripheral blood.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2016
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.