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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001381-14 | EudraCT Number |
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The objectives of Part 1 of the study were:
The objective of the extension (Part 2) was:
-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg | Experimental | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
| Lymphoid Blast Crisis 400 mg | Experimental | Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
| Acute Lymphoblastic Leukemia 400 mg | Experimental | Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg | Experimental | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STI571 400 mg | Drug | STI571 capsules and tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC). | Up to 3 years after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Bone marrow (BM) cytogenetic analysis was required at baseline, after 12 weeks (visit 22) and after 24 weeks (visit 28) to evaluate Ph chromosome positivity. In several participants, this was also done after 4 and 8 weeks. Based on the percentage of Philadelphia chromosome positive (Ph+) cells = (positive cells/examined cells)x100, at each BM assessment the cytogenetic response was classified as: Complete, 0% Ph+ cells; Partial, >0 - 35% Ph+ cells; Minor, >35 - 65% Ph+ cells; Minimal, >65 - 95% Ph+ cells; None, >95% Ph+ cells; Not done: <20 metaphases were examined and/or response could not be assigned. Cytogenetic response was defined as confirmed complete or partial response. A BM sample was considered as assessable for cytogenetic response only if it contained ≥20 metaphases. However, an assessment of partial response was retained in a sample with <20 metaphases when it was immediately preceded or followed by a complete or partial response in another sample with ≥20 metaphases. |
Not provided
Inclusion Criteria:
Male or female participants, aged ≥18 years, with a histologically confirmed diagnosis of Ph+ leukemia of one of the following types:
With serum serum glutamate oxaloacetate transaminase (aspartate aminotransferase) and serum glutamate pyruvate transaminase (alanine aminotransferase) not more than 3 x upper limit of normal (ULN) (or not more than 5xULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2xULN, and total serum bilirubin level not more than 3xULN (bilirubin limit was 1.5xULN before protocol amendment 1)
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Faber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| New York Presbyterian Hospital |
On July 31, 2002, the core study was completed and 76 participants on study medication were enrolled to the extension protocol #1 (E1), and as of July 31, 2004, 42 participants were still on treatment and were enrolled in a further extension protocol #2 (E2).
Participants took part in this study at 14 investigative sites in France, Germany, Italy, United Kingdom, Switzerland and United States from August 9, 1999 to September 23, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lymphoid Blast Crisis 600 mg | Experimental | Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
| Acute Lymphoblastic Leukemia 600 mg | Experimental | Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
| Acute Myeloid/Myelogenous Leukemia 600 mg | Experimental | Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
|
| STI571 600 mg | Drug | STI571 capsules and tablets |
|
|
| Up to 3 years after start of treatment |
| Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Time to response was defined for all participants as the time until first documented response (which was confirmed ≥4 weeks later). | Up to 3 years after start of treatment |
| Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Duration of response was defined as the time between first documented response (which was confirmed ≥4 weeks later) and the earliest date of the following: loss of response (when any of the criteria for response were no longer fulfilled); progression to blast crisis (≥30% blasts in peripheral blood or bone marrow, extramedullary involvement other than liver/spleen enlargement); discontinuation due to adverse event, laboratory abnormality, unsatisfactory therapeutic effect or death. | Up to 3 years after start of treatment |
| Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Progression to blast crisis was defined as ≥30% blasts in peripheral blood or bone marrow or as extramedullary involvement other than liver or spleen enlargement. | Up to 3 years after start of treatment |
| Overall Survival by Disease | To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date. | 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatment |
| Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date. | 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatment |
| 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 | 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 | Monza | Italy |
| Novartis Investigative Site | London | United Kingdom |
| FG001 |
| Lymphoid Blast Crisis 400 mg |
Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| FG002 | Acute Lymphoblastic Leukemia 400 mg | Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| FG003 | Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| FG004 | Lymphoid Blast Crisis 600 mg | Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| FG005 | Acute Lymphoblastic Leukemia 600 mg | Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| FG006 | Acute Myeloid/Myelogenous Leukemia 600 mg | Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Completed Part 1 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-treat (ITT) population consisted of all enrolled participants. Baseline characteristics were collected and reported together for each disease and dose groups (Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg, Lymphoid Blast Crisis 400 mg or 600 mg, Acute Lymphoblastic Leukemia 400 mg or 600 mg, and Acute Myeloid/Myelogenous Leukemia 600 mg) of participants, as pre-specified in the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | STI571 | Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC). | ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years after start of treatment |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Bone marrow (BM) cytogenetic analysis was required at baseline, after 12 weeks (visit 22) and after 24 weeks (visit 28) to evaluate Ph chromosome positivity. In several participants, this was also done after 4 and 8 weeks. Based on the percentage of Philadelphia chromosome positive (Ph+) cells = (positive cells/examined cells)x100, at each BM assessment the cytogenetic response was classified as: Complete, 0% Ph+ cells; Partial, >0 - 35% Ph+ cells; Minor, >35 - 65% Ph+ cells; Minimal, >65 - 95% Ph+ cells; None, >95% Ph+ cells; Not done: <20 metaphases were examined and/or response could not be assigned. Cytogenetic response was defined as confirmed complete or partial response. A BM sample was considered as assessable for cytogenetic response only if it contained ≥20 metaphases. However, an assessment of partial response was retained in a sample with <20 metaphases when it was immediately preceded or followed by a complete or partial response in another sample with ≥20 metaphases. | ITT population consists of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years after start of treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Time to response was defined for all participants as the time until first documented response (which was confirmed ≥4 weeks later). | ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Median | 95% Confidence Interval | months | Up to 3 years after start of treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Duration of response was defined as the time between first documented response (which was confirmed ≥4 weeks later) and the earliest date of the following: loss of response (when any of the criteria for response were no longer fulfilled); progression to blast crisis (≥30% blasts in peripheral blood or bone marrow, extramedullary involvement other than liver/spleen enlargement); discontinuation due to adverse event, laboratory abnormality, unsatisfactory therapeutic effect or death. | ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Median | 95% Confidence Interval | months | Up to 3 years after start of treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | Progression to blast crisis was defined as ≥30% blasts in peripheral blood or bone marrow or as extramedullary involvement other than liver or spleen enlargement. | ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Median | 95% Confidence Interval | months | Up to 3 years after start of treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival by Disease | To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date. | ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants by disease groups. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Number | 95% Confidence Interval | percentage of participants | 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia | To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date. | ITT population consisted of all enrolled participants. The overall survival was calculated as per initial dose (400 mg or 600 mg) only for participants with Accelerated Phase Chronic Myeloid/Myelogenous Leukemia, as pre-specified in the protocol. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further. | Posted | Number | 95% Confidence Interval | percentage of participants | 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatment |
|
Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
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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 | STI571 | Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported. | 20 | 293 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Systematic Assessment | Sudden death |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | 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 |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D010677 | Philadelphia Chromosome |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014178 | Translocation, Genetic |
| D002869 | Chromosome Aberrations |
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
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| OG001 | Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
|
|
|
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
|
|
|
| OG002 | Acute Lymphoid Leukemia | Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| OG003 | Acute Myeloid/Myelogenous Leukemia | Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
|
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg |
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
|
|