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

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ClinicalTrials.gov Identifier: NCT02736721
Recruitment Status : Completed
First Posted : April 13, 2016
Results First Posted : August 5, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Myelogenous Leukemia, Chronic Drug: Peginterferon alfa-2a Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Open Label Expanded Access-Program of Pegylated Interferon Alfa-2a (Pegasys) in Patients With Chronic Myelogenous Leukemia (CML)
Study Start Date : September 2003
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Other Name: Pegasys


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736721


Locations
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Germany
Freiburg, Germany, 79106
Mainz, Germany, 55101
Mannheim, Germany, 68167
Marburg, Germany, 35043
Tübingen, Germany, 72076
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02736721    
Other Study ID Numbers: ML17395
First Posted: April 13, 2016    Key Record Dates
Results First Posted: August 5, 2016
Last Update Posted: September 20, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents