Prove cliniche Nct
Clinical Trial Results:
A phase II open-label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive chronic myeloid leukemia in myeloid blast crisis extended for in total of 11 years (Extension 1: 2002-2004 and Extension 2: 2004- 2013)
| Summary | |
EudraCT number | 2005-001380-61 |
Trial protocol | IT |
Global end of trial date | 22 Apr 2013 |
| Results information | |
Results version number | v1(current) |
This version publication date | 28 Jul 2018 |
First version publication date | 28 Jul 2018 |
Other versions | |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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| Trial identification | |||
Sponsor protocol code | CSTI571A0102E2 | ||
| Additional study identifiers | |||
ISRCTN number | - | ||
US NCT number | NCT00171158 | ||
WHO universal trial number (UTN) | - | ||
| Sponsors | |||
Sponsor organisation name | Novartis Pharma AG | ||
Sponsor organisation address | CH-4002, Basel, Switzerland, | ||
Public contact | Clinical Disclosure Office, Novartis Pharma AG, +41 613241111, | ||
Scientific contact | Clinical Disclosure Office, Novartis Pharma AG, +41 613241111, | ||
| Paediatric regulatory details | |||
Is trial part of an agreed paediatric investigation plan (PIP) | No | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? | No | ||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? | No | ||
| Results analysis stage | |||
Analysis stage | Final | ||
Date of interim/final analysis | 22 Apr 2013 | ||
Is this the analysis of the primary completion data? | No | ||
Global end of trial reached? | Yes | ||
Global end of trial date | 22 Apr 2013 | ||
Was the trial ended prematurely? | No | ||
| General information about the trial | |||
Main objective of the trial | To enable patients to have access to study drug, continue study treatment and to decrease data collection to include overall survival and serious adverse events. | ||
Protection of trial subjects | The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. | ||
Background therapy | - | ||
Evidence for comparator | - | ||
Actual start date of recruitment | 26 Mar 2004 | ||
Long term follow-up planned | No | ||
Independent data monitoring committee (IDMC) involvement? | No | ||
| Population of trial subjects | |||
Number of subjects enrolled per country | |||
Country: Number of subjects enrolled | France: 17 | ||
Country: Number of subjects enrolled | Germany: 62 | ||
Country: Number of subjects enrolled | Switzerland: 5 | ||
Country: Number of subjects enrolled | United Kingdom: 35 | ||
Country: Number of subjects enrolled | United States: 126 | ||
Country: Number of subjects enrolled | Italy: 15 | ||
Worldwide total number of subjects | 260 | ||
EEA total number of subjects | 129 | ||
Number of subjects enrolled per age group | |||
In utero | 0 | ||
Preterm newborn - gestational age | 0 | ||
Newborns (0-27 days) | 0 | ||
Infants and toddlers (28 days-23 months) | 0 | ||
Children (2-11 years) | 0 | ||
Adolescents (12-17 years) | 0 | ||
Adults (18-64 years) | 199 | ||
From 65 to 84 years | 61 | ||
85 years and over | 0 | ||
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| Recruitment | |||||||||||||||||||||||||||||
Recruitment details | - | ||||||||||||||||||||||||||||
| Pre-assignment | |||||||||||||||||||||||||||||
Screening details | Patients recruited were adults with Philadelphia chromosome-positive (Ph+) CML transformed into myeloid BC. Patients that completed extension study #1 could enter into the extension study #2. | ||||||||||||||||||||||||||||
| Period 1 | |||||||||||||||||||||||||||||
Period 1 title | Overall Trial | ||||||||||||||||||||||||||||
Is this the baseline period? | Yes | ||||||||||||||||||||||||||||
Allocation method | Not applicable | ||||||||||||||||||||||||||||
Blinding used | Not blinded | ||||||||||||||||||||||||||||
| Arms | |||||||||||||||||||||||||||||
| Arm title | All subjects | ||||||||||||||||||||||||||||
Arm description | STI571 was originally provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect. | ||||||||||||||||||||||||||||
Arm type | Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name | STI571 | ||||||||||||||||||||||||||||
Investigational medicinal product code | |||||||||||||||||||||||||||||
Other name | imatinib, Glivec®, Gleevec® | ||||||||||||||||||||||||||||
Pharmaceutical forms | Tablet | ||||||||||||||||||||||||||||
Routes of administration | Oral use | ||||||||||||||||||||||||||||
Dosage and administration details | STI571 was supplied as 25 mg, 50 mg and 100 mg tablets, taken orally, once a day with 250 ml of water after breakfast for 400 mg/day and 600 mg/day doses, or twice a day after breakfast and the evening meal for 800 mg/day (2 x 400 mg/day) dose. | ||||||||||||||||||||||||||||
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| Period 2 | |||||||||||||||||||||||||||||
Period 2 title | Overall Trial - E2 extension | ||||||||||||||||||||||||||||
Is this the baseline period? | No | ||||||||||||||||||||||||||||
Allocation method | Not applicable | ||||||||||||||||||||||||||||
Blinding used | Not blinded | ||||||||||||||||||||||||||||
| Arms | |||||||||||||||||||||||||||||
| Arm title | All subjects - Extension phase | ||||||||||||||||||||||||||||
Arm description | STI571 was provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect. | ||||||||||||||||||||||||||||
Arm type | Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name | STI571 | ||||||||||||||||||||||||||||
Investigational medicinal product code | imatinib mesylate | ||||||||||||||||||||||||||||
Other name | imatinib, Glivec®, Gleevec® | ||||||||||||||||||||||||||||
Pharmaceutical forms | Tablet | ||||||||||||||||||||||||||||
Routes of administration | Oral use | ||||||||||||||||||||||||||||
Dosage and administration details | STI571 was supplied as 25 mg, 50 mg and 100 mg tablets, taken orally, once a day with 250 ml of water after breakfast for 400 mg/day and 600 mg/day doses, or twice a day after breakfast and the evening meal for 800 mg/day (2 x 400 mg/day) dose. | ||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: In Extension 1 (E1) of the study, 13 subjects discontinued. Reasons are unknown. | |||||||||||||||||||||||||||||
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| Baseline characteristics reporting groups | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Overall Trial | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| End points reporting groups | |||
Reporting group title | All subjects | ||
Reporting group description | STI571 was originally provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect. | ||
Reporting group title | All subjects - Extension phase | ||
Reporting group description | STI571 was provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect. | ||
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End point title | Summary overall survival (ITT) [1] | ||||||||||
End point description | Overall survival was defined as the time from first dose of STI571 to death of the patient. | ||||||||||
End point type | Primary | ||||||||||
End point timeframe | From first dose until death of the patient, up to 11 years. | ||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses have been reported for this primary end point | |||||||||||
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| Notes [2] - Intent-to-treat (ITT) population. | |||||||||||
| No statistical analyses for this end point | |||||||||||
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End point title | Summary of overall survival (by month) [3] | ||||||||||||||||||||||||||||||
End point description | Kaplan-Meier estimates per month. | ||||||||||||||||||||||||||||||
End point type | Primary | ||||||||||||||||||||||||||||||
End point timeframe | From first dose until death of the patient, up to 11 years. | ||||||||||||||||||||||||||||||
| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses have been reported for this primary end point | |||||||||||||||||||||||||||||||
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| Notes [4] - Intent-to-treat (ITT) population | |||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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| Adverse events information [1] | |||||||||||
Timeframe for reporting adverse events | Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. | ||||||||||
Adverse event reporting additional description | After 31-Jul-2002 no safety data was collected in the clinical database and Serious adverse events (SAEs) were reported in the safety database. No drug-related SAEs leading to discontinuation or drug-related deaths were reported after 31-Jul-2002 in the safety database. | ||||||||||
Assessment type | Systematic | ||||||||||
| Dictionary used for adverse event reporting | |||||||||||
Dictionary name | MedDRA | ||||||||||
Dictionary version | 16.0 | ||||||||||
| Reporting groups | |||||||||||
Reporting group title | All subjects | ||||||||||
Reporting group description | STI571 was originally provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect. | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: After 31-Jul-2002 no safety data was collected in the clinical database and Serious adverse events (SAEs) were reported in the safety database. | |||||||||||
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Substantial protocol amendments (globally) | |||
| Were there any global substantial amendments to the protocol? Yes | |||
Date | Amendment | ||
01 Mar 2004 | To allow patients to receive study drug for as long as the patient should require it. Also, it changed the frequency of bone marrow cytogenetics for those patients maintaining a complete cytogenetic response to annually from twice yearly until the patient reached month 48 of the extension or 31-July-2006, whichever date came first. | ||
01 Mar 2008 | To accommodate patient site visits on a yearly (±3 months) basis rather than every six months. In addition, a new section was added to include new protocol deviation language which stated that under no circumstances were protocol deviations allowed. | ||
Interruptions (globally) | |||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats | |||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||