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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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.
Unnamed facility
Freiburg im Breisgau, Germany
Unnamed facility
Mainz, Germany
Unnamed facility
Mannheim, Germany
Unnamed facility
Marburg, Germany
Unnamed facility
Tübingen, Germany
Number of Participants With Complete Hematologic Response
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.
Time frame: Up to approximately 7 years
Time to Loss of Previous Hematologic Response
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.
Time frame: Up to approximately 7 years
Number of Participants With Major Cytogenetic Response (CyR)
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+.
Time frame: Up to approximately 7 years
Time to Loss of Previous CyR
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+.
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Time frame: Up to approximately 7 years
Number of Participants With Molecular Response (MR)
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.
Time frame: Up to approximately 7 years
Time to Loss of Previous MR
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.
Time frame: Up to approximately 7 years