Clinical Trial Results:
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
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Summary
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EudraCT number |
2010-022946-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
05 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
05 May 2017
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First version publication date |
05 May 2017
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Other versions |
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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
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Sponsor protocol code |
AALL0622
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00720109 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Children’s Oncology Group
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Sponsor organisation address |
222 E Huntington Dr, Suite 100, Monrovia, United States, 91016
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Public contact |
Peter C. Adamson - COG Group Chair, The Children’s Hospital of Philadelphia, 1 (215) 590-6359, Adamson@email.chop.edu
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Scientific contact |
Peter C. Adamson - COG Group Chair, The Children’s Hospital of Philadelphia, 1 (215) 590-6359, Adamson@email.chop.edu
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000567-PIP01-09 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Mar 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Mar 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objectives of this trial were to determine the feasibility and toxicity of dasatinib in combination with intensified chemotherapy in young patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia and to determine whether the intensification of tyrosine kinase inhibition (TKI) through the addition of dasatinib to induction therapy (on days 15-28) and the substitution of dasatinib for imatinib mesylate during post-induction therapy will lead to a 3-year event-free survival (EFS) in ≥ 60% of these patients.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
The CA180204 (COG AALL0622) chemotherapy backbone was administered by the investigating site’s standard prescribing procedures according to country availability and specific regulatory requirements. Initially, to compensate for elimination of prophylactic cranial radiotherapy, intrathecal (IT) methotrexate (MTX) was changed to triple intrathecal therapy (ITT, consisting of cytarabine, MTX, and hydrocortisone) on day 29 of induction, and an additional dose of ITT was added on the first day of Consolidation 1. This increased the number of IT chemotherapy treatments from 18 to 20. Reductions in the chemotherapy backbone were implemented by Amendment during the course of the study. These changes were reduction of high-dose (HD) MTX infusions from 9 to 7 and reduction of IT chemotherapy administrations from 20 to 18. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 56
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Country: Number of subjects enrolled |
Canada: 4
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Country: Number of subjects enrolled |
Australia: 2
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Country: Number of subjects enrolled |
New Zealand: 1
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Worldwide total number of subjects |
63
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
3
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Children (2-11 years) |
37
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Adolescents (12-17 years) |
16
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Adults (18-64 years) |
7
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 47 sites in 4 countries. | ||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 63 subjects were enrolled and 62 were treated. Reason for non-treatment was physician determined it was not in subject's best interest. | ||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Induction Period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dasatinib, discontinuous (Cohort 1) | ||||||||||||||||||||||||||||||
Arm description |
Subjects in Cohort 1 (discontinuous dasatinib) received 70 weeks of dasatinib treatment (of the total of 131 weeks of chemotherapy). During induction (4 weeks) Dasatinib was administered during weeks 3-4. During consolidation (2 blocks of 3 weeks each) Dasatinib was administered during weeks 6-7, 9-10. During Re-Induction / Intensification Dasatinib was administered during weeks 12-13, 15-16, 18-19, 21-22, 24-25, 27-28, 30-31, 33-34. During Maintenance Dasatinib was administered during weeks 36-37, 40-41, 44-45, 48-49, 52-53, 56-57, 60-61, 64-65, 68-69, 72-73, 76-77, 80-81, 84-85, 88-89, 92-93, 96-97, 100-101, 104-105, 108-109, 112-113, 116-117, 120-121, 124-125, 128-129. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dasatinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received Dasatinib tablets orally at a dose of 60 mg/m2 once daily (QD). If dasatinib at a dose of 60 mg/m2 daily was not well tolerated, subjects received dasatinib treatment at 48 mg/m2 daily. If necessary to permit administration in young children, the intact tablets could be placed (and allowed to dissolve) in 1 ounce of lemonade (a double strength juice is recommended to obscure the bitter taste), or 1 ounce of preservative-free apple juice, or 1 ounce of preservative-free orange juice. mg=milligram
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Arm title
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Dasatinib, continuous (Cohort 2) | ||||||||||||||||||||||||||||||
Arm description |
Subjects in Cohort 2 (continuous dasatinib) received a total of 128 weeks of dasatinib treatment (of the 131 weeks of chemotherapy). During induction (4 weeks), Dasatinib was administered during weeks 3-4. During consolidation (2 blocks of 3 weeks each), Dasatinib was administered during weeks 6-11. During Re-Induction / Intensification, Dasatinib was administered during weeks 12-35. During Maintenance, Dasatinib was administered during weeks 36-131. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dasatinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received Dasatinib tablets orally at a dose of 60 mg/m2 once daily (QD). If dasatinib at a dose of 60 mg/m2 daily was not well tolerated, subjects received dasatinib treatment at 48 mg/m2 daily. If necessary to permit administration in young children, the intact tablets could be placed (and allowed to dissolve) in 1 ounce of lemonade (a double strength juice is recommended to obscure the bitter taste), or 1 ounce of preservative-free apple juice, or 1 ounce of preservative-free orange juice. mg=milligram
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Out of 63 subjects who were enrolled only 62 subjects were treated. |
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Period 2
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Period 2 title |
Risk Stratification Period
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dasatinib, discontinuous (Cohort 1) | ||||||||||||||||||||||||||||||
Arm description |
The Risk Stratification period followed the Induction period. During Risk Stratification, the minimal residual disease (MRD) classified subjects into risk groups. All High-Risk subjects and all Standard-Risk subjects with matched sibling donors were urged to proceed to hematopoietic stem cell transplant (HSCT). All subjects who did not proceed to HSCT continued on study and received chemotherapy plus Dasatinib. Subjects in Cohort 1 (discontinuous dasatinib) received 70 weeks of dasatinib treatment (of the total of 131 weeks of chemotherapy) during the Induction period. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dasatinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received Dasatinib tablets orally at a dose of 60 mg/m2 once daily (QD). If dasatinib at a dose of 60 mg/m2 daily was not well tolerated, subjects received dasatinib treatment at 48 mg/m2 daily. If necessary to permit administration in young children, the intact tablets could be placed (and allowed to dissolve) in 1 ounce of lemonade (a double strength juice is recommended to obscure the bitter taste), or 1 ounce of preservative-free apple juice, or 1 ounce of preservative-free orange juice. mg=milligram
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Arm title
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Dasatinib, continuous (Cohort 2) | ||||||||||||||||||||||||||||||
Arm description |
The Risk Stratification period followed the Induction period. During Risk Stratification, the minimal residual disease (MRD) was used to classify subjects into risk groups. All High-Risk subjects and all Standard-Risk subjects with matched sibling donors were urged to proceed to hematopoietic stem cell transplant (HSCT). All subjects who did not proceed to HSCT continued on study and received chemotherapy plus Dasatinib. Subjects in Cohort 2 (continuous dasatinib) received a total of 128 weeks of Dasatinib treatment (of the 131 weeks of chemotherapy) during the Induction period. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dasatinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received Dasatinib tablets orally at a dose of 60 mg/m2 once daily (QD). If dasatinib at a dose of 60 mg/m2 daily was not well tolerated, subjects received dasatinib treatment at 48 mg/m2 daily. If necessary to permit administration in young children, the intact tablets could be placed (and allowed to dissolve) in 1 ounce of lemonade (a double strength juice is recommended to obscure the bitter taste), or 1 ounce of preservative-free apple juice, or 1 ounce of preservative-free orange juice. mg=milligram
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Baseline characteristics reporting groups
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Reporting group title |
Dasatinib, discontinuous (Cohort 1)
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Reporting group description |
Subjects in Cohort 1 (discontinuous dasatinib) received 70 weeks of dasatinib treatment (of the total of 131 weeks of chemotherapy). During induction (4 weeks) Dasatinib was administered during weeks 3-4. During consolidation (2 blocks of 3 weeks each) Dasatinib was administered during weeks 6-7, 9-10. During Re-Induction / Intensification Dasatinib was administered during weeks 12-13, 15-16, 18-19, 21-22, 24-25, 27-28, 30-31, 33-34. During Maintenance Dasatinib was administered during weeks 36-37, 40-41, 44-45, 48-49, 52-53, 56-57, 60-61, 64-65, 68-69, 72-73, 76-77, 80-81, 84-85, 88-89, 92-93, 96-97, 100-101, 104-105, 108-109, 112-113, 116-117, 120-121, 124-125, 128-129. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dasatinib, continuous (Cohort 2)
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Reporting group description |
Subjects in Cohort 2 (continuous dasatinib) received a total of 128 weeks of dasatinib treatment (of the 131 weeks of chemotherapy). During induction (4 weeks), Dasatinib was administered during weeks 3-4. During consolidation (2 blocks of 3 weeks each), Dasatinib was administered during weeks 6-11. During Re-Induction / Intensification, Dasatinib was administered during weeks 12-35. During Maintenance, Dasatinib was administered during weeks 36-131. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Standard-Risk Cohort 2
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Standard-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with a bone marrow status M1 (< 5% lymphoblasts; complete response in bone marrow) and with minimal residual disease (MRD) < 1% at the end of Induction and MRD < 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
High-Risk Cohort 2
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
High-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with minimal residual disease (MRD) ≥ 1% at the end of Induction or MRD ≥ 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
Standard-Risk Cohort 1
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Standard-Risk Cohort 1 is defined as the population of subjects in Cohort 1 with a bone marrow status M1 (< 5% lymphoblasts; complete response in bone marrow) and with minimal residual disease (MRD) < 1% at the end of Induction and MRD < 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
High-Risk Cohort 1
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
High-Risk Cohort 1 is defined as the population of subjects in Cohort 1 with minimal residual disease (MRD) ≥ 1% at the end of Induction or MRD ≥ 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
Any Risk, Cohort 2
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Any Risk Cohort 2 combines the population of subjects in Standard-Risk Cohort 2 and High-Risk Cohort 2.
Standard-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with a bone marrow status M1 (< 5% lymphoblasts; complete response in bone marrow) and with minimal residual disease (MRD) < 1% at the end of Induction and MRD < 0.01% at the end of Consolidation Block 2.
High-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with minimal residual disease (MRD) ≥ 1% at the end of Induction or MRD ≥ 0.01% at the end of Consolidation Block 2.
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End points reporting groups
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Reporting group title |
Dasatinib, discontinuous (Cohort 1)
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Reporting group description |
Subjects in Cohort 1 (discontinuous dasatinib) received 70 weeks of dasatinib treatment (of the total of 131 weeks of chemotherapy). During induction (4 weeks) Dasatinib was administered during weeks 3-4. During consolidation (2 blocks of 3 weeks each) Dasatinib was administered during weeks 6-7, 9-10. During Re-Induction / Intensification Dasatinib was administered during weeks 12-13, 15-16, 18-19, 21-22, 24-25, 27-28, 30-31, 33-34. During Maintenance Dasatinib was administered during weeks 36-37, 40-41, 44-45, 48-49, 52-53, 56-57, 60-61, 64-65, 68-69, 72-73, 76-77, 80-81, 84-85, 88-89, 92-93, 96-97, 100-101, 104-105, 108-109, 112-113, 116-117, 120-121, 124-125, 128-129. | ||
Reporting group title |
Dasatinib, continuous (Cohort 2)
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Reporting group description |
Subjects in Cohort 2 (continuous dasatinib) received a total of 128 weeks of dasatinib treatment (of the 131 weeks of chemotherapy). During induction (4 weeks), Dasatinib was administered during weeks 3-4. During consolidation (2 blocks of 3 weeks each), Dasatinib was administered during weeks 6-11. During Re-Induction / Intensification, Dasatinib was administered during weeks 12-35. During Maintenance, Dasatinib was administered during weeks 36-131. | ||
Reporting group title |
Dasatinib, discontinuous (Cohort 1)
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Reporting group description |
The Risk Stratification period followed the Induction period. During Risk Stratification, the minimal residual disease (MRD) classified subjects into risk groups. All High-Risk subjects and all Standard-Risk subjects with matched sibling donors were urged to proceed to hematopoietic stem cell transplant (HSCT). All subjects who did not proceed to HSCT continued on study and received chemotherapy plus Dasatinib. Subjects in Cohort 1 (discontinuous dasatinib) received 70 weeks of dasatinib treatment (of the total of 131 weeks of chemotherapy) during the Induction period. | ||
Reporting group title |
Dasatinib, continuous (Cohort 2)
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Reporting group description |
The Risk Stratification period followed the Induction period. During Risk Stratification, the minimal residual disease (MRD) was used to classify subjects into risk groups. All High-Risk subjects and all Standard-Risk subjects with matched sibling donors were urged to proceed to hematopoietic stem cell transplant (HSCT). All subjects who did not proceed to HSCT continued on study and received chemotherapy plus Dasatinib. Subjects in Cohort 2 (continuous dasatinib) received a total of 128 weeks of Dasatinib treatment (of the 131 weeks of chemotherapy) during the Induction period. | ||
Subject analysis set title |
Standard-Risk Cohort 2
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Standard-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with a bone marrow status M1 (< 5% lymphoblasts; complete response in bone marrow) and with minimal residual disease (MRD) < 1% at the end of Induction and MRD < 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
High-Risk Cohort 2
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
High-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with minimal residual disease (MRD) ≥ 1% at the end of Induction or MRD ≥ 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
Standard-Risk Cohort 1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Standard-Risk Cohort 1 is defined as the population of subjects in Cohort 1 with a bone marrow status M1 (< 5% lymphoblasts; complete response in bone marrow) and with minimal residual disease (MRD) < 1% at the end of Induction and MRD < 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
High-Risk Cohort 1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
High-Risk Cohort 1 is defined as the population of subjects in Cohort 1 with minimal residual disease (MRD) ≥ 1% at the end of Induction or MRD ≥ 0.01% at the end of Consolidation Block 2.
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Subject analysis set title |
Any Risk, Cohort 2
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Any Risk Cohort 2 combines the population of subjects in Standard-Risk Cohort 2 and High-Risk Cohort 2.
Standard-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with a bone marrow status M1 (< 5% lymphoblasts; complete response in bone marrow) and with minimal residual disease (MRD) < 1% at the end of Induction and MRD < 0.01% at the end of Consolidation Block 2.
High-Risk Cohort 2 is defined as the population of subjects in Cohort 2 with minimal residual disease (MRD) ≥ 1% at the end of Induction or MRD ≥ 0.01% at the end of Consolidation Block 2.
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End point title |
Percent of Standard Risk Cohort 2 Subjects with 3-Year Event Free Survival (EFS) [1] | ||||||||
End point description |
EFS = time from entry on study until an event occurred. Events for EFS = first occurrence of the following: induction failure, relapse at any site, secondary malignancy, or death.
Induction failure = disease progression during Induction. A bone marrow evaluation took place at the end of Induction, and disease progression was concluded if the lymphoblast count was > 25% (M3 bone marrow status).
Relapse = any recurrence of disease, whether in the marrow or extramedullary site: - Central Nervous System (CNS) relapse: Positive cytomorphology and 5 or more white blood cells/microliter in cerebral spinal fluid, or any signs of CNS leukemia such a facial nerve palsy, brain/eye involvement, or hypothalamic syndrome. - Testicular relapse: Must be documented by testicular biopsy, in the absence of concomitant bone marrow relapse. - Bone marrow relapse: Subjects with M3 marrow (>25% blasts) at any point after the beginning of re-Induction.
A 1-sided 95% confidence interval was reported.
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End point type |
Primary
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End point timeframe |
Day 1 up to Year 3
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| 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: Only descriptive summary statistics were planned for this outcome measure. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percent of Subjects with 3-Year Event Free Survival (EFS) | ||||||||||||||||||||||||
End point description |
EFS = time from entry on study until an event occurred. Events for EFS = first occurrence of the following: induction failure, relapse at any site, secondary malignancy, or death.
Induction failure = disease progression during Induction. A bone marrow evaluation took place at the end of Induction, and disease progression was concluded if the lymphoblast count was > 25% (M3 bone marrow status).
Relapse = any recurrence of disease, whether in the marrow or extramedullary site: - Central Nervous System (CNS) relapse: Positive cytomorphology and 5 or more white blood cells/microliter in cerebral spinal fluid, or any signs of CNS leukemia such a facial nerve palsy, brain/eye involvement, or hypothalamic syndrome. - Testicular relapse: Must be documented by testicular biopsy, in the absence of concomitant bone marrow relapse. - Bone marrow relapse: Subjects with M3 marrow (>25% blasts) at any point after the beginning of re-Induction.
A 1-sided 95% confidence interval was reported.
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End point type |
Secondary
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End point timeframe |
Day 1 up to Year 3
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percent of Subjects in Cohort 2 with Minimal Residual Disease (MRD) at the End of Induction [2] | ||||||||
End point description |
Minimal residual disease levels were the proportion of leukemic cells in a sample at a specific time point. Percentage MRD was also categorized as follows: < 0.01%, 0.01%-0.099%, and >= 0.1%.
MRD-positive was defined as having a minimal residual disease > 0.01%. Induction therapy was conducted between days 15-28. A 1-sided 95% confidence interval was reported.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only the specified arms was planned to be reported for this outcome measure. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percent of Subjects in Cohort 2 with Minimal Residual Disease (MRD) at the End of Consolidation [3] | ||||||||
End point description |
Minimal residual disease levels were the proportion of leukemic cells in a sample at a specific time point. Percentage MRD was also categorized as follows: < 0.01%, 0.01%-0.099%, and >= 0.1%.
MRD-positive was defined as having a minimal residual disease > 0.01%. Consolidation therapy in Cohort 2 was conducted between weeks 6-11. A 1-sided 95% confidence interval was reported.
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End point type |
Secondary
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End point timeframe |
Week 11
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| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only the specified arms was planned to be reported for this outcome measure. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percent of Subjects with Overall Survival (OS) at Year 3 | ||||||||||||
End point description |
Overall survival was defined as time in months from the date of entry on study to the date of death due to any cause. Subjects who had not died or who were lost to follow-up were censored on the last date the subject was known to be
alive. A 1-sided 95% confidence interval was reported.
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End point type |
Secondary
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End point timeframe |
Year 3
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From 1st dose date through last dose date plus 30 days (approx. 3 years)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Dasatinib
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Reporting group description |
Dasatinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
