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Clinical Trials in the USA / NCT03589326
Active, not recruiting Phase 3

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

NCT03589326 · tracked via the Priya Life Science USA tracker
Sponsor
Takeda
Phase
Phase 3
Started
2018-10-04
Last updated
2025-11-26

Condition(s) studied

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Investigational drug(s) / intervention(s)

PonatinibImatinibVincristineDexamethasoneCytarabineMethotrexatePrednisone

Ponatinib: Ponatinib Tablets.

Imatinib: Imatinib Tablets.

Vincristine: Vincristine IV injection.

Dexamethasone: Dexamethasone Tablets.

Cytarabine: Cytarabine IV infusion.

Methotrexate: Methotrexate IV infusion.

Prednisone: Prednisone Tablets.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines. 2. Eastern Cooperative Oncology Group (ECOG) performance status of \<=2. Exclusion Criteria: 1. With a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML). 2. Prior/current treatment with any systemic anticancer therapy (including but not limited to any tyrosine kinase inhibitor \[TKI\]) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than 1 cycle), which should be discussed with the sponsor's medical monitor/designee. 3. Currently taking drugs that are known to have a risk of causing prolonged corrected QT (QTc) or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued). 4. Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within at least 14 days before the first dose of study drug. 5. Uncontrolled active serious infection that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 6. Major surgery within 28 days before randomization (minor surgical procedures such as catheter placement or BM biopsy are not exclusionary criteria). 7. Known human immunodeficiency virus (HIV) seropositivity, known active hepatitis B or C infection. 8. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis. 9. Uncontrolled hypertriglyceridemia (triglycerides \>450 milligram per deciliter \[mg/dL\]). 10. Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 11. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. 12. Clinical manifestations of CNS or extramedullary involvement with ALL other than lymphadenopathy or hepatosplenomegaly. 13. Autoimmune disease with potential CNS involvement. 14. Known significant neuropathy of Grade \>=2 severity. 15. Clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thrombotic/embolic event (VTE) disease. 16. Have a significant bleeding disorder unrelated to ALL.

Primary outcome measure(s)

Trial sites (92)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
City of Hope - Duarte Duarte California
University of California Los Angeles Los Angeles California
Augusta University Georgia Cancer Center Augusta Georgia
Indiana University Indianapolis Indiana
Indiana Blood & Marrow Transplantation Indianapolis Indiana
University of Kansas Medical Center Research Institute Kansas City Kansas
University of Maryland Medical Center Baltimore Maryland
Hackensack University Medical Center Hackensack New Jersey
Roswell Park Cancer Institute Buffalo New York
Monter Cancer Center New Hyde Park New York
Stony Brook University Medical Center Stony Brook New York
Oregon Health and Science University Portland Oregon
The University of Texas MD Anderson Cancer Center Houston Texas
Methodist Hospital San Antonio Texas
Sanatorio Allende Córdoba Argentina
Hospital Privado Centro Medico de Cordoba Córdoba Argentina
Royal North Shore Hospital Saint Leonards New South Wales
Box Hill Hospital Box Hill Victoria
Monash Medical Centre Clayton Victoria
Hanusch Krankenhaus Wiener Gebietskrankenkasse Vienna State of Vienna
Ordensklinikum Linz Elisabethinen Linz Upper Austria
Universitaetsklinik Fuer Innere Medizin I Vienna Austria
Hospital Sao Rafael-Monte Tabor Salvador Estado de Bahia
Hospital Erasto Gaertner Curitiba Paraná
Hospital da Cidade Passo Fundo Rio Grande do Sul
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
Hemocentro Campinas Unicamp Campinas São Paulo
Fundacao Doutor Amaral Carvalho Jaú São Paulo
Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo Ribeirão Preto São Paulo
HEMORIO Instituto Estadual de Hematologia Arthur Siqueira de Cavalcanti Rio de Janeiro Brazil
Instituto do Cancer do Estado de Sao Paulo São Paulo Brazil
Fundacao Antonio Prudente - A.C.Camargo Cancer Center São Paulo Brazil
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski Sofia Sofia
855 West 12th Avenue Vancouver British Columbia
The Ottawa Hospital Ottawa Ontario
Hopital Charles-LeMoyne Greenfield Park Quebec
Hopital Maisonneuve-Rosemont Montreal Quebec
Henan Cancer Hospital Zhengzhou Henan
The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital Suzhou Jiangsu

+ 52 more sites — see the full list on the official registry below.

On this site

📄 Gleevec (imatinib) drug profile → 📄 Deltasone (prednisone) drug profile →

More Takeda trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03589326 on ClinicalTrials.gov ↗ ← All trials in the USA