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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001382-33 | EudraCT Number |
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During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants With Chronic Myeloid Leukemia | Experimental | Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STI571 | Drug | STI571 oral capsules or tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cytogenetic Response (Complete Cytogenetic Response and Major Cytogenetic Response) to STI571 | Response was evaluated from bone marrow aspirates and biopsy samples. Bone marrow cytogenetic studies were performed every 3 months during the core phase of the study, then twice yearly, then annually to evaluate Philadelphia chromosome positive (Ph+). Cytogenetic response was defined as the best response the participant achieved during study. Based on the percentage of Ph+ cells = (positive cells/ examined cells) x100, at each BM assessment the cytogenetic response was classified as: Complete Cytogenetic Response (CCyR):, 0% Ph+ cells; Partial Cytogenetic Response (PCyR):, >0 - 35% Ph+ cells; Minor: >35 - 65% Ph+ cells; and Minimal: >65 - 95% Ph+ cells, None: >95 % Ph+ cells and Not done: <20 metaphases were examined and/or response could not be assigned. Major Cytogenetic Response (MCyR) was defined as sum of the CCyR plus PCyR rates. | Up to 6 years after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Hematologic Response to STI571 | Hematologic response was evaluated from hematology measurements in the peripheral blood. Complete hematological response was defined as normalization of peripheral blood counts [WBC and platelet count < upper limit of normal (ULN) at the laboratory where the analysis was performed], with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks. |
Not provided
Inclusion Criteria:
Participants included in the study were:
Consenting males or females greater than or equal to (≥)18 years of age with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
With a documented failure of interferon-alpha (IFN) or an IFN-containing therapy, characterized as resistance or refractoriness defined as any of the following:
In this report all refractory populations were referred to as "relapsed" populations.
Exclusion Criteria:
Participants excluded from the study were:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hematologic Failure | Participants failed to achieve a complete hematologic response, defined as lasting for at least 1 month despite 6 or more months of an interferon-alpha containing regimen, or had a rising white blood cell count (WBC) [to a level 20 x 10^9/L] confirmed by two samples taken at least two weeks apart after achieving a complete hematological response while receiving an interferon- alpha containing regimen of at least 25 million international units (MIU) per week. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 milligrams (mg). During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
Not provided
| 12 months after the start of treatment |
| Duration of Complete Hematologic Response to STI571 | Duration of hematologic response was defined as the time from the first documentation of the complete hematologic response to the date the loss of complete hematologic response is documented. Loss of complete hematological response was defined as a rising WBC count (increased to a level above the ULN at the laboratory where the analysis was performed confirmed by two samples obtained one month apart). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. Complete hematological response was defined as normalization of peripheral blood counts (WBC and platelet count < ULN at the laboratory where the analysis was performed), with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks. | 12 months after the start of treatment |
| Time to Complete Hematologic Response to STI571 | Time to Complete Hematologic Response was defined for all participants with calculated confirmed complete hematologic response as the time until first documented response (which was confirmed >= 4 weeks). Complete hematological response was defined as normalization of peripheral blood counts (WBC and platelet count < ULN at the laboratory where the analysis was performed), with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks. | 12 months after the start of treatment |
| Number of Participants With Common Toxicity Criteria Grade 3 or 4 Cancer-related Symptoms | National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each adverse event (AE) term, the Common Toxicity Criteria (CTC). Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. Cancer-related symptoms included fever, night sweats, bone pain, arthralgia, abdominal discomfort, fatigue and anorexia. | Up to 9 months after the start of treatment |
| Number of Participants With Grade 3 or 4 Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status was recorded at baseline and every 3 months during the core study. The ECOG Performance Scale has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. | Up to 9 months after the start of treatment |
| Percentage of Participants Alive Over Time Based on Kaplan-Meier Estimates | Overall survival was defined as the time from the first dose of STI571 to the death of the participant. If a participant is not known to have died, survival was censored at the time of last contact. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. | 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 and 156 months |
| Tampa |
| Florida |
| 33612 |
| United States |
| Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21231 | United States |
| Dana Faber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University/Kamanos Cancer Center | Detroit | Michigan | 48201 | United States |
| C/O V. Ward - Washington Univ. school of Medicine | St Louis | Missouri | 63110 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Oregon Health & sciences University | Portland | Oregon | 97239 | United States |
| MD Anderson Cancer Center, University of Texas | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Lille | France |
| Novartis Investigative Site | Pessac | France |
| Novartis Investigative Site | Poitiers | France |
| Novartis Investigative Site | Frankfurt | Germany |
| Novartis Investigative Site | Leipzig | Germany |
| Novartis Investigative Site | Mainz | Germany |
| Novartis Investigative Site | Mannheim | Germany |
| Novartis Investigative Site | Bologna | Italy |
| Novartis Investigative Site | Milan | Italy |
| Novartis Investigative Site | Monza | Italy |
| Novartis Investigative Site | Orbassano | Italy |
| Novartis Investigative Site | Pavia | Italy |
| Novartis Investigative Site | Rome | Italy |
| Novartis Investigative Site | Udine | Italy |
| Novartis Investigative Site | Basel | Switzerland |
| Novartis Investigative Site | London | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | United Kingdom |
| FG001 | Cytogenetic Failure | Participants' bone marrow (BM) cytogenetics showed greater than or equal to (>=) 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| FG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented greater than (>) Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| COMPLETED | Disposition data is reported till end of study. |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hematologic Failure | Participants failed to achieve a complete hematologic response, defined as lasting for at least 1 month despite 6 or more months of an interferon-alpha containing regimen, or had a rising WBC (to a level 20 x 10^9/L) confirmed by two samples taken at least two weeks apart after achieving a complete hematological response while receiving an interferon- alpha containing regimen of at least 25 MIU per week. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| BG001 | Cytogenetic Failure | Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| BG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Cytogenetic Response (Complete Cytogenetic Response and Major Cytogenetic Response) to STI571 | Response was evaluated from bone marrow aspirates and biopsy samples. Bone marrow cytogenetic studies were performed every 3 months during the core phase of the study, then twice yearly, then annually to evaluate Philadelphia chromosome positive (Ph+). Cytogenetic response was defined as the best response the participant achieved during study. Based on the percentage of Ph+ cells = (positive cells/ examined cells) x100, at each BM assessment the cytogenetic response was classified as: Complete Cytogenetic Response (CCyR):, 0% Ph+ cells; Partial Cytogenetic Response (PCyR):, >0 - 35% Ph+ cells; Minor: >35 - 65% Ph+ cells; and Minimal: >65 - 95% Ph+ cells, None: >95 % Ph+ cells and Not done: <20 metaphases were examined and/or response could not be assigned. Major Cytogenetic Response (MCyR) was defined as sum of the CCyR plus PCyR rates. | Intent-To-Treat (ITT) population included all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 years after the start of treatment |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Hematologic Response to STI571 | Hematologic response was evaluated from hematology measurements in the peripheral blood. Complete hematological response was defined as normalization of peripheral blood counts [WBC and platelet count < upper limit of normal (ULN) at the laboratory where the analysis was performed], with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks. | ITT population included all enrolled participants. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months after the start of treatment |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Hematologic Response to STI571 | Duration of hematologic response was defined as the time from the first documentation of the complete hematologic response to the date the loss of complete hematologic response is documented. Loss of complete hematological response was defined as a rising WBC count (increased to a level above the ULN at the laboratory where the analysis was performed confirmed by two samples obtained one month apart). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. Complete hematological response was defined as normalization of peripheral blood counts (WBC and platelet count < ULN at the laboratory where the analysis was performed), with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks. | ITT population included all enrolled participants. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Error | months | 12 months after the start of treatment |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Complete Hematologic Response to STI571 | Time to Complete Hematologic Response was defined for all participants with calculated confirmed complete hematologic response as the time until first documented response (which was confirmed >= 4 weeks). Complete hematological response was defined as normalization of peripheral blood counts (WBC and platelet count < ULN at the laboratory where the analysis was performed), with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks. | ITT population included all enrolled participants. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | months | 12 months after the start of treatment |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Common Toxicity Criteria Grade 3 or 4 Cancer-related Symptoms | National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each adverse event (AE) term, the Common Toxicity Criteria (CTC). Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. Cancer-related symptoms included fever, night sweats, bone pain, arthralgia, abdominal discomfort, fatigue and anorexia. | ITT population included all enrolled participants. | Posted | Count of Participants | Participants | Up to 9 months after the start of treatment |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or 4 Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status was recorded at baseline and every 3 months during the core study. The ECOG Performance Scale has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. | ITT population included all enrolled participants. | Posted | Count of Participants | Participants | Up to 9 months after the start of treatment |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive Over Time Based on Kaplan-Meier Estimates | Overall survival was defined as the time from the first dose of STI571 to the death of the participant. If a participant is not known to have died, survival was censored at the time of last contact. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. | ITT population included all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 and 156 months |
|
Up to approximately 14 years
Safety population included all participants who received at least 1 dose of study drug. Serious adverse events were not collected separately for each disease group (hematologic failure, cytogenetic failure and interferon-alpha intolerant) of participants. All the participants were properly combined for analysis, regardless of the disease groups. Other non-serious adverse events were not collected during the extension phase within the clinical database.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants With Chronic Myeloid Leukemia | Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). | 13 | 532 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Prostate Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
Not provided
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D010677 | Philadelphia Chromosome |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
| D014178 | Translocation, Genetic |
| D002869 | Chromosome Aberrations |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| >= 50 to <= 60 years |
|
| >= 60 to <= 70 years |
|
| >= 70 years |
|
| Male |
|
|
| OG001 | Cytogenetic Failure | Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| OG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
|
|
| OG001 | Cytogenetic Failure | Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| OG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
|
|
| OG001 | Cytogenetic Failure | Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| OG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
|
|
| Cytogenetic Failure |
Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| OG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
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| OG001 | Cytogenetic Failure | Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| OG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
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Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
| OG002 | Interferon-alpha Intolerance | Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years). |
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