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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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+. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freiburg im Breisgau | 79106 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a | Participants who have previously participated in study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a | Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis population included all enrolled participants. | Posted | Number | participants | Up to approximately 7 years |
|
Up to approximately 7 years
Analysis population included all enrolled participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peginterferon Alfa-2a | Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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|
| 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. | 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. | Up to approximately 7 years |
| Mainz |
| 55101 |
| Germany |
| Mannheim | 68167 | Germany |
| Marburg | 35043 | Germany |
| Tübingen | 72076 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 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. | Analysis population included all enrolled participants. | Posted | Median | 95% Confidence Interval | months | Up to approximately 7 years |
|
|
|
| Primary | 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+. | Analysis population included all enrolled participants. | Posted | Number | participants | Up to approximately 7 years |
|
|
|
| Primary | 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+. | Analysis population included all enrolled participants. | Posted | Median | 95% Confidence Interval | years | Up to approximately 7 years |
|
|
|
| Primary | 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. | Analysis population included all enrolled participants. | Posted | Number | participants | Up to approximately 7 years |
|
|
|
| Primary | 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. | Analysis population included all enrolled participants. | Posted | Median | 95% Confidence Interval | years | Up to approximately 7 years |
|
|
|
| 13 |
| 41 |
| 35 |
| 41 |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Colostomy | Surgical and medical procedures | MedDRA (13.1) | Non-systematic Assessment |
|
| Finger amputation | Surgical and medical procedures | MedDRA (13.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |