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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03007147
Registration number
NCT03007147
Ethics application status
Date submitted
28/12/2016
Date registered
2/01/2017
Date last updated
15/08/2024
Titles & IDs
Public title
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
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Scientific title
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
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Secondary ID [1]
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NCI-2016-01588
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Secondary ID [2]
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AALL1631
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia
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B Acute Lymphoblastic Leukemia
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Mixed Phenotype Acute Leukemia
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T Acute Lymphoblastic Leukemia
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Allogeneic Hematopoietic Stem Cell Transplantation
Treatment: Drugs - Calaspargase Pegol
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexrazoxane Hydrochloride
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Etoposide
Treatment: Other - Filgrastim
Treatment: Drugs - Ifosfamide
Treatment: Drugs - Imatinib Mesylate
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Methylprednisolone
Treatment: Drugs - Pegaspargase
Treatment: Drugs - Prednisolone
Other interventions - Questionnaire Administration
Treatment: Drugs - Therapeutic Hydrocortisone
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate
Experimental: Arm A (imatinib mesylate, EsPhALL chemotherapy) - See Detailed Description
Experimental: Arm B (imatinib mesylate, COG/BFM chemotherapy) - See Detailed Description.
Experimental: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT) - See Detailed Description
Treatment: Surgery: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HSCT
Treatment: Drugs: Calaspargase Pegol
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IV, SC, or IT
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
Given PO or IV
Treatment: Drugs: Dexrazoxane Hydrochloride
Given IV
Treatment: Drugs: Doxorubicin
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Other: Filgrastim
Given IV
Treatment: Drugs: Ifosfamide
Given IV
Treatment: Drugs: Imatinib Mesylate
Given PO
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin Calcium
Given PO or IV
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IT
Treatment: Drugs: Methylprednisolone
Given IV
Treatment: Drugs: Pegaspargase
Given IV
Treatment: Drugs: Prednisolone
Given PO
Other interventions: Questionnaire Administration
Ancillary studies
Treatment: Drugs: Therapeutic Hydrocortisone
Given IT
Treatment: Drugs: Thioguanine
Given PO
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Treatment: Other
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Intervention code [4]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)
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Assessment method [1]
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Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [1]
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DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients)
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Assessment method [1]
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Three-year DFS (time from randomization to relapse, second malignancy, or death in complete remission) and 95% CI of SR pediatric Ph+ and ABL-class fusion positive patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients
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Assessment method [2]
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The proportion of patients who receive at least 75% of intended doses.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate
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Assessment method [3]
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Three-year EFS and 95% CI for high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate. EFS is defined as the time from the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event (resistant disease \[MRD \>= 10-2 or morphologic residual disease at end of consolidation block 3\], relapse, progressive disease \[i.e., MRD \>= 10-2 at two post-HSCT time points separated by at least 2 weeks\], second malignancy, or death in complete remission), or time to last follow-up for patients without events.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms
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Assessment method [4]
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Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The rate of infections during the post IB/pre-maintenance phases of treatment will be described for each randomization group.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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EFS of all Ph+ patients
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Assessment method [5]
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Three-year EFS and 95% CI for Ph+ ALL patients. EFS here is defined as the time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignant, or death, whichever occurs first.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Overall survival (OS) of all Ph+ patients
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Assessment method [6]
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Three-year OS and 95% CI for Ph+ ALL patients. OS is defined as the time from study enrollment to death from any cause.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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OS of SR Ph+ patients
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Assessment method [7]
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Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients
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Timepoint [7]
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Up to 3 years
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Secondary outcome [8]
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OS of SR Ph+ patients by randomization group
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Assessment method [8]
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Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients by randomization group: treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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OS of high risk Ph+ patients
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Assessment method [9]
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Three-year OS (time from the date of MRD assessment at end-IB to death from any cause) and 95% CI of HR pediatric Ph+ patients.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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EFS of all eligibility ABL-class fusion positive ALL patients
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Assessment method [10]
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Three-year EFS (time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignancy, or death, whichever occurs first) and 95% CI of ABL-class fusion positive patients.
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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OS of all eligibility ABL-class fusion positive ALL patients
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Assessment method [11]
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Three-year OS (the time from study enrollment to death from any cause) and 95% CI of ABL-class fusion positive patients.
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Timepoint [11]
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Up to 3 years
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Eligibility
Key inclusion criteria
* For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
* For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe
* In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or ABL-class fusion must be submitted for rapid central review within 72 hours of study enrollment
* >= 1 year (365 days) and =< 21 years at ALL diagnosis
* Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or molecular methodologies
* ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization (FISH, e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
* Ph+ patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
* Ph+ patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vinCRIStine
* Ph+ patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
* ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy (Induction IA phase)
* ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vinCRIStine dose
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
* Direct bilirubin =< 2.0 mg/dL
* Shortening fraction of >= 27% by echocardiogram
* Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
* Corrected QT interval, QTc < 480 msec
* Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis, before study enrollment
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as follows:
* 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
* 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
* 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
* 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
* 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
* >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
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Minimum age
1
Year
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known history of chronic myelogenous leukemia (CML)
* ALL developing after a previous cancer treated with cytotoxic chemotherapy
* Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
* Down syndrome
* Pregnancy and breast feeding
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol
* Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
* Prior treatment with dasatinib, or any TKI other than imatinib
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/08/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2027
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Actual
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Sample size
Target
475
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Hunter Regional Mail Centre
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Sydney Children's Hospital - Randwick
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The Children's Hospital at Westmead - Westmead
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Queensland Children's Hospital - South Brisbane
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Princess Margaret Hospital for Children - Perth
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Recruitment hospital [6]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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2310 - Hunter Regional Mail Centre
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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6008 - Perth
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Recruitment postcode(s) [6]
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6009 - Perth
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Recruitment outside Australia
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Alabama
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San Juan
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Saudi Arabia
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Riyadh
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Sweden
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Scania
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Switzerland
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Zurich
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Other
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EsPhALL
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
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Trial website
https://clinicaltrials.gov/study/NCT03007147
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Lewis B Silverman
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Children's Oncology Group
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03007147
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