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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1206-2370 | Other Identifier | World Health Organization | |
| HC6-24-c220300 | Registry Identifier | Health Canada | |
| jRCT2031210230 | Registry Identifier | jRCT | |
| 2023-508463-71-00 | EU Trial (CTIS) Number |
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In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib.
The main aim of this study is to compare the number of participants on each treatment that show no signs of disease.
Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.
The drug being tested in this study is called ponatinib. Ponatinib is being tested to treat people who have newly diagnosed Ph+ ALL. This study will look at the efficacy of ponatinib in participants in addition to standard care.
The study will enroll approximately 230 participants. Participants will be randomized in a 2:1 ratio to receive oral ponatinib or imatinib (Cohort A and Cohort B, respectively) daily throughout the study.
All participants will be asked to take ponatinib or imatinib at the same time each day with reduced-intensity chemotherapy in induction phase (Cycles 1 to 3), consolidation phase (Cycles 4 to 9) and maintenance phase (Cycles 10 to 20). At the end of the 20 cycles, participants will remain on ponatinib or imatinib (administered as a single agent). The dose of ponatinib in consolidation and maintenance phase will start with the last dose given in the previous phase. The dose can be modified based on MRD-negative CR results.
This multi-center trial will be conducted in Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, France, Mexico, Greece, Italy, Japan, Korea, Republic Of, Poland, Romania, Russia, Spain, Taiwan, Province Of China, Turkey, Finland and the United States. Participants including those who achieve a clinical response, may receive study drug until they are deceased, have failed to achieve the primary endpoint, have experienced relapse from CR or have progressive disease, have an unacceptable toxicity, have withdrawn consent, have proceeded to HSCT, or until the sponsor terminates the study, whichever occurs first. After disease progression, all participants will be contacted every 3 months for survival follow-up. Participants will be followed until completion of the study or until the participant's death has been reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Ponatinib 30 milligram (mg) | Experimental | Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (<60 years [yrs]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m^2 as 2-hour IV infusion (<60 yrs) and 250 mg/m^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022. |
|
| Cohort B: Imatinib 600 mg | Active Comparator | Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour-IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponatinib | Drug | Ponatinib Tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) > 1000 per microliter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). | From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | EFS is defined as the dates of randomization until death due to any cause or failure to achieve CR by end of induction or relapse from CR. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).Relapse from CR: reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope - Duarte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40165400 | Derived | Ashaye A, Shi L, Aldoss I, Montesinos P, Vachhani P, Rocha V, Papayannidis C, Leonard JT, Baer MR, Ribera JM, McCloskey J, Wang J, Rane D, Guo S. Quality-Adjusted Time Without Symptoms of Disease or Toxicity (Q-TWiST) in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Comparison of Ponatinib Versus Imatinib. Cancer Med. 2025 Apr;14(7):e70780. doi: 10.1002/cam4.70780. | |
| 38722621 |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) were enrolled in a 2:1 ratio to receive ponatinib or imatinib.
Participants took part in the study at 77 investigative sites in Australia, China, Korea, Taiwan, Austria, France, Greece, Italy, Poland, Russia, Spain, Turkey, United States, Canada, Mexico, Argentina and Brazil from 04 October 2018 to 31 July 2027. This study is ongoing. The data is reported for primary outcome measures up to 12 August 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Ponatinib 30 mg | Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (<60 years [yrs]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m^2 as 2-hour IV infusion (<60 yrs) and 250 mg/m^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| IP (Cycles 1-3) (Cycle Length=28 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2021 | Aug 11, 2023 |
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It is an open-label trial, therefore investigators and participants are unblinded.
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| Imatinib | Drug | Imatinib Tablets. |
|
|
| Vincristine | Drug | Vincristine IV injection. |
|
| Dexamethasone | Drug | Dexamethasone Tablets. |
|
| Cytarabine | Drug | Cytarabine IV infusion. |
|
| Methotrexate | Drug | Methotrexate IV infusion. |
|
| Prednisone | Drug | Prednisone Tablets. |
|
| Baseline up to approximately 3 to 6 years |
| Percentage of Participants With CR and Incomplete Complete Remission (CRi) | CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC. | End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days) |
| Percentage of Participants With Molecular Response | Molecule response is assessed by 3-Log Reduction (MR3), Molecular Response 4-Log Reduction (MR4) and Molecular Response 4.5-Log Reduction (MR4.5). MR3 is defined as molecular response 3-log reduction (<=0.1% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=1000 ABL1 transcripts. MR4 is defined as molecular response 4-log reduction (<=0.01% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. MR4.5 is defined as Molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts. | End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days) |
| Percentage of Participants With Primary Induction Failure (PIF) | PIF is defined as participants who received treatment for ALL but never achieved CR or CRi by the end of induction. PIF is not limited by the number of unsuccessful treatments; this disease status only applies to recipients who have never been in CR or CRi. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC. | Up to 3 months |
| Percentage of Participants With Overall Response Rate (ORR) | ORR is defined as CR + CRi by end of induction. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC. | Up to 3 months |
| Percentage of MRD-Negative CR | MRD is defined as the percentage of participants achieving CR who are MRD-negative at multiple intervals after end of induction. MRD negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Up to approximately 3 to 6 years |
| Duration of MRD-Negative CR | Duration of MRD-negative CR is defined as interval between the first assessment at which the criteria for MRD-negative CR are met until the earliest date at which loss of MRD negativity or relapse from CR occurs. MRD negativity (MR4): <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Up to approximately 3 to 6 years |
| Duration of CR | Duration of CR is defined as interval between the first assessment at which the criteria for CR are met until the earliest date at which relapse from CR occurs. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Up to approximately 3 to 6 years |
| Time to Treatment Failure | Time to treatment failure is defined as time to end of study randomized treatment (except for hematopoietic stem cell transplantation [HSCT] without loss of MRD-negative CR) due to safety and efficacy reasons. MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). | Up to approximately 6 years |
| Duration of MR4.5 | Duration of MR4.5 is defined as interval between the first assessment at which the criteria for MR4.5 are met until the earliest date at which loss of MR4.5 occurs. MR4.5 is molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts. | Up to approximately 3 to 6 years |
| Percentage of On-Study Participants With Overall Survival (OS) | On-study participants with or without HSCT will be evaluated. OS is defined as interval between randomization and death due to any cause, censored at the last contact date when the participant was alive. | Up to approximately 3 to 6 years |
| Percentage of On-Study Participants With Relapse From CR | On-study participants with or without HSCT will be evaluated. Relapse from CR is defined as reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Up to approximately 3 to 6 years |
| Overall Survival (OS) | OS is defined as interval between the randomization and death due to any cause, censored at the last contact date when the participant was alive. | Up to approximately 3 to 6 years |
| Duarte |
| California |
| 91010 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Augusta University Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Indiana Blood & Marrow Transplantation | Indianapolis | Indiana | 46237 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Monter Cancer Center | New Hyde Park | New York | 11042 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Hospital Privado Centro Medico de Cordoba | Córdoba | X5014KEH | Argentina |
| Royal North Shore Hospital | Saint Leonards | New South Wales | 2065 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Hanusch Krankenhaus Wiener Gebietskrankenkasse | Vienna | State of Vienna | 1140 | Austria |
| Ordensklinikum Linz Elisabethinen | Linz | Upper Austria | 4020 | Austria |
| Universitaetsklinik Fuer Innere Medizin I | Vienna | 1090 | Austria |
| Hospital Sao Rafael-Monte Tabor | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Hospital Erasto Gaertner | Curitiba | Paraná | 81520-060 | Brazil |
| Hospital da Cidade | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Hemocentro Campinas Unicamp | Campinas | São Paulo | 130383-878 | Brazil |
| Fundacao Doutor Amaral Carvalho | Jaú | São Paulo | 17210-120 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| HEMORIO Instituto Estadual de Hematologia Arthur Siqueira de Cavalcanti | Rio de Janeiro | 20211-030 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246-000 | Brazil |
| Fundacao Antonio Prudente - A.C.Camargo Cancer Center | São Paulo | 01509-900 | Brazil |
| University Multiprofile Hospital for Active Treatment Saint Ivan Rilski | Sofia | Sofia | 1431 | Bulgaria |
| 855 West 12th Avenue | Vancouver | British Columbia | V5Z 1M9 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Hopital Charles-LeMoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital | Suzhou | Jiangsu | 215006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Institute of Hematology & Blood Diseases Hospital of CAMS & PUMC | Tianjin | 300041 | China |
| Helsingin ja Uudenmaan sairaanhoitopiiri | Helsinki | 00029 HUS | Finland |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
| Institut Universitaire du Cancer de Toulouse Oncopole | Toulouse | Midi-pyrenees | 31059 | France |
| Center Hospitalier Universitaire d'Angers | Angers | Pays de la Loire Region | 49933 | France |
| Centre Hospitalier de Versailles Hopital Andre Mignot | Le Chesnay | Île-de-France Region | 78157 | France |
| University General Hospital of Athens Attikon | Chaïdári | Attica | 12462 | Greece |
| Evaggelismos General Hospital | Athens | Ipsiladou 45-47 | 10676 | Greece |
| General University Hospital of Patras Panagia I Voithia | Pátrai | Rio | 26504 | Greece |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Forli-cesena | 47014 | Italy |
| Azienda Policlinico San Martino | Genoa | Liguria | 16132 | Italy |
| Azienda Ospedaliera San Gerardo di Monza | Monza | Monza E Brianza | 20090 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | Reggio Nella Emilia | 42123 | Italy |
| Ospedale dell'Angelo | Mestre | Venezia | 30174 | Italy |
| Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera Vito Fazzi | Lecce | 73100 | Italy |
| Istituto Scientifico Universitario San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliero-Universitaria di Modena Policlinico | Modena | 41124 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello | Palermo | 90146 | Italy |
| Azienda USL della Romagna | Ravenna | 48121 | Italy |
| Centro di Ematologia Policlinico Umberto I Universita Sapienza di Roma | Roma | 00161 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| Chiba Aoba Municipal Hospital | Chiba | Chiba | 260-0852 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| Aiiku Hospital | Sapporo | Hokkaido | 064-0804 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Szpital Uniwersytecki w Krakowie | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Uniwersytecki Szpital Kliniczny we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs | Olsztyn | Warmian-Masurian Voivodeship | 10-228 | Poland |
| City Clinical Hospital named after Vikentiy Vikentyevich Veresaev | Moscow | Moscow CITY | 127644 | Russia |
| Sverdlovsk Regional Clinical Hospital #1 | Yekaterinburg | Sverdlovsk Oblast | 620102 | Russia |
| National Research Center for Hematology, Dept. of Hematology/Oncology and BMT | Moscow | 125167 | Russia |
| Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation | Saint Petersburg | 197341 | Russia |
| The Catholic University of Korea St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Kyungpook National University Hospital | Daegu | Gyeongsangbuk-do | 41944 | South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Yeungnam University Hospital | Daegu | 42415 | South Korea |
| Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol | Badalona | Catalonia | 08916 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hualien Tzu Chi Hospital | Hualien City | Hualien | 970 | Taiwan |
| China Medical University Hospital | Taichung | Taichung CITY | 40447 | Taiwan |
| National Cheng Kung University Hospital | Tainan | Tainan CITY | 70403 | Taiwan |
| Ankara Universitesi Tp Fakultesi | Ankara | 06590 | Turkey (Türkiye) |
| Derived |
| Jabbour E, Kantarjian HM, Aldoss I, Montesinos P, Leonard JT, Gomez-Almaguer D, Baer MR, Gambacorti-Passerini C, McCloskey J, Minami Y, Papayannidis C, Rocha V, Rousselot P, Vachhani P, Wang ES, Wang B, Hennessy M, Vorog A, Patel N, Yeh T, Ribera JM. Ponatinib vs Imatinib in Frontline Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2024 Jun 4;331(21):1814-1823. doi: 10.1001/jama.2024.4783. |
| FG001 | Cohort B: Imatinib 600 mg | Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour-IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022. |
| Efficacy Evaluable Population | Efficacy evaluable population was defined as all participants in the ITT population with BCR:ABL1 dominant variant of p190 or p210 confirmed by central lab. |
|
| Safety Population | The safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| CP (Cycles 4-9) (Cycle Length=28 Days) |
|
| MP (Cycles 10-20) (Cycle Length=28 Days) |
|
ITT analysis set was defined as all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Ponatinib 30 mg | Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (<60 years [yrs]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m^2 as 2-hour IV infusion (<60 yrs) and 250 mg/m^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022. |
| BG001 | Cohort B: Imatinib 600 mg | Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour-IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Number analyzed are the number of participants available for height at baseline. | Mean | Standard Deviation | centimeters (cm) |
| ||||||||||||||
| Weight | Number analyzed are the number of participants available for weight at baseline. | Mean | Standard Deviation | kilograms (kg) |
| ||||||||||||||
| Body Surface Area (BSA) | Number analyzed are the number of participants available for BSA at baseline. | Mean | Standard Deviation | meters squared (m^2) |
|
| 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 | Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) > 1000 per microliter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). | ITT population with p190/p210 variant was defined as all participants in the ITT population who were identified by the central laboratory as having baseline breakpoint cluster region-Abelson1 (BCR-ABL1) dominant variants of p190 or p210. | Posted | Count of Participants | Participants | From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days) |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) | EFS is defined as the dates of randomization until death due to any cause or failure to achieve CR by end of induction or relapse from CR. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).Relapse from CR: reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Not Posted | Jul 2028 | Baseline up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR and Incomplete Complete Remission (CRi) | CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC. | Not Posted | Jul 2028 | End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Molecular Response | Molecule response is assessed by 3-Log Reduction (MR3), Molecular Response 4-Log Reduction (MR4) and Molecular Response 4.5-Log Reduction (MR4.5). MR3 is defined as molecular response 3-log reduction (<=0.1% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=1000 ABL1 transcripts. MR4 is defined as molecular response 4-log reduction (<=0.01% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. MR4.5 is defined as Molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts. | Not Posted | Jul 2028 | End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Primary Induction Failure (PIF) | PIF is defined as participants who received treatment for ALL but never achieved CR or CRi by the end of induction. PIF is not limited by the number of unsuccessful treatments; this disease status only applies to recipients who have never been in CR or CRi. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC. | Not Posted | Jul 2028 | Up to 3 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response Rate (ORR) | ORR is defined as CR + CRi by end of induction. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC. | Not Posted | Jul 2028 | Up to 3 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of MRD-Negative CR | MRD is defined as the percentage of participants achieving CR who are MRD-negative at multiple intervals after end of induction. MRD negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of MRD-Negative CR | Duration of MRD-negative CR is defined as interval between the first assessment at which the criteria for MRD-negative CR are met until the earliest date at which loss of MRD negativity or relapse from CR occurs. MRD negativity (MR4): <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CR | Duration of CR is defined as interval between the first assessment at which the criteria for CR are met until the earliest date at which relapse from CR occurs. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time to treatment failure is defined as time to end of study randomized treatment (except for hematopoietic stem cell transplantation [HSCT] without loss of MRD-negative CR) due to safety and efficacy reasons. MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). | Not Posted | Jul 2028 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of MR4.5 | Duration of MR4.5 is defined as interval between the first assessment at which the criteria for MR4.5 are met until the earliest date at which loss of MR4.5 occurs. MR4.5 is molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of On-Study Participants With Overall Survival (OS) | On-study participants with or without HSCT will be evaluated. OS is defined as interval between randomization and death due to any cause, censored at the last contact date when the participant was alive. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of On-Study Participants With Relapse From CR | On-study participants with or without HSCT will be evaluated. Relapse from CR is defined as reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as interval between the randomization and death due to any cause, censored at the last contact date when the participant was alive. | Not Posted | Jul 2028 | Up to approximately 3 to 6 years | Participants |
From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: Ponatinib 30 mg | Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (<60 years [yrs]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m^2 as 2-hour IV infusion (<60 yrs) and 250 mg/m^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022. | 21 | 163 | 97 | 163 | 159 | 163 |
| EG001 | Cohort B: Imatinib 600 mg | Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour-IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022. | 13 | 81 | 45 | 81 | 80 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Mucormycosis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| SARS-CoV-2 viraemia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Stenotrophomonas bacteraemia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| pH urine decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm ruptured | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Brachiocephalic vein thrombosis | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
| |
| Psychomotor retardation | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
| |
| Immunisation reaction | Immune system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA25.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA25.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical | Director | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2022 | Aug 11, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C545373 | ponatinib |
| D000068877 | Imatinib Mesylate |
| D014750 | Vincristine |
| D003907 | Dexamethasone |
| D003561 | Cytarabine |
| D008727 | Methotrexate |
| D011241 | Prednisone |
| 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 |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D011244 | Pregnadienediols |
Not provided
Not provided
|
|
|
| Non-Hispanic and Latino |
|
|
| Not reported |
|
|
| Unknown |
|
|
|
| China |
|
|
| Korea, South |
|
|
| Taiwan |
|
|
| Austria |
|
|
| France |
|
|
| Greece |
|
|
| Italy |
|
|
| Poland |
|
|
| Russia |
|
|
| Spain |
|
|
| Turkey |
|
|
| Canada |
|
|
| Mexico |
|
|
| United States |
|
|
| Argentina |
|
|
| Brazil |
|
|
|
|
|