A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase — From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)
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).
Trial sites (92)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Takeda trials in Italy
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 Italy