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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03589326

Studienbeginn:
August 2018

Letztes Update:
24.06.2021

Wirkstoff:
Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine, Methotrexate, Prednisone

Indikation (Clinical Trials):
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphoid, Philadelphia Chromosome

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Takeda

Collaborator:
-

Studienleiter

Study Director
Study Director
Takeda

Kontakt

Studienlocations
(3 von 124)

Hospital Italiano de Buenos Aires
C1181ACH Ciudad Autonoma de Buenos Aires
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Phone: +5401149590348
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Minsk Scientific and Practical Center of Surgery, Transplantation and Haematology
220045 Minsk
BelarusRekrutierend» Google-Maps
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Phone: +3758172727091
E-Mail: ponatinib.mspc@gmail.com
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Republican Scientific and Practical Center of Children's Oncology, Hematology and Immunology
223053 Minsk
BelarusRekrutierend» Google-Maps
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Phone: +3758172024222
E-Mail: aleinikova2004@mail.ru
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Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo
14048-900 Ribeirao Preto
BrazilRekrutierend» Google-Maps
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Phone: +551636022956
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HEMORIO Instituto Estadual de Hematologia
20211-030 Rio de Janeiro
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Phone: +5521233286112141
E-Mail: diretor.tecnico@hemorio.rj.gov.br
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Fundacao Antonio Prudente - A.C.Camargo Cancer Center
01509-900 Sao Paulo
BrazilRekrutierend» Google-Maps
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Phone: +551121895017
E-Mail: jayr.filho@accamargo.org.br
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University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
1431 Sofia
BulgariaRekrutierend» Google-Maps
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Phone: +359024034838
E-Mail: aradinoff@hotmail.com
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University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
5800 Pleven
BulgariaRekrutierend» Google-Maps
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Phone: +359064886335
E-Mail: ntzvetkov50@gmail.com
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The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital
215006 Suzhou
ChinaRekrutierend» Google-Maps
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Phone: +8651267783686
E-Mail: qiuhuiying@aliyun.com
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Institut Universitaire du Cancer de Toulouse Oncopole
31059 Toulouse Cedex 09
FranceRekrutierend» Google-Maps
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Phone: +33531156269
E-Mail: huguet.francoise@iuct-oncopole.fr
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University General Hospital of Heraklion Panepistimiako Geniko Nosokomeio Irakleiou
71110 Heraklion
GreeceRekrutierend» Google-Maps
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Phone: +302813402805
E-Mail: epapadak@med.uoc.gr
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
47014 Meldola
ItalyRekrutierend» Google-Maps
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Phone: +390516364077
E-Mail: giovanni.martinelli@irst.emr.it
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Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
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Phone: +390516363827
E-Mail: cristina.papayannidis@gmail.com
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Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
90146 Palermo
ItalyRekrutierend» Google-Maps
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Phone: +390916802023
E-Mail: francesco.fabbiano@villasofia.it
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Centro di Ematologia Policlinico Umberto I Universita Sapienza di Roma
00161 Roma
ItalyRekrutierend» Google-Maps
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Phone: +3906441639824
E-Mail: chiaretti@bce.uniroma1.it
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The Catholic University of Korea St. Vincent's Hospital
16247 Suwon
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Phone: +820312497114
E-Mail: jakimapril@gmail.com
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Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie - Oddzial w Gliwicach
44-101 Gliwice
PolandRekrutierend» Google-Maps
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Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs
10-228 Olsztyn
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City Clinical Hospital named after Vikentiy Vikentyevich Veresaev
127644 Moscow
Russian FederationRekrutierend» Google-Maps
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Phone: +79216365472
E-Mail: shuvaev77@mail.ru
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City Clinical Hospital No. 52 of the Moscow Healthcare Department
123182 Moscow
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Phone: +74991961788
E-Mail: misyurina_elena@mail.ru
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National Research Center for Hematology, Dept. of Hematology/Oncology and BMT
125167 Moscow
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Phone: +784956122123
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Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation
197341 Saint Petersburg
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Phone: +78127023765
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Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
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Alle anzeigen

Studien-Informationen

Detailed Description:

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Number of Participants with Minimal Residual Disease (MRD)-Negative Complete Remission (CR) (Time Frame - From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length is equal to [=] 28 days)):
MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: less than or equal to (<=) 0.01 percent (%) breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with greater than or equal to (>=) 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) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).



Secondary outcome:

1. Event-free survival (EFS) (Time Frame - Baseline up to approximately 3 to 6 years):
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.

2. Percentage of Participants with CR and Incomplete Complete Remission (CRi) (Time Frame - 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)):
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.

3. Percentage of Participants with Molecular Response (Time Frame - 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)):
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.

4. Percentage of Participants with Primary Induction Failure (PIF) (Time Frame - Up to 3 months):
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.

5. Percentage of Participants with Overall Response Rate (ORR) (Time Frame - Up to 3 months):
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.

6. Percentage of MRD-Negative CR (Time Frame - Up to approximately 3 to 6 years):
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.

7. Duration of MRD-Negative CR (Time Frame - Up to approximately 3 to 6 years):
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.

8. Duration of CR (Time Frame - Up to approximately 3 to 6 years):
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.

9. Time to Treatment Failure (Time Frame - Up to approximately 6 years):
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).

10. Duration of MR4.5 (Time Frame - Up to approximately 3 to 6 years):
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.

11. Percentage of On-Study Participants with Overall Survival (OS) (Time Frame - Up to approximately 3 to 6 years):
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.

12. Percentage of On-Study Participants with Relapse From CR (Time Frame - Up to approximately 3 to 6 years):
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.

13. Overall Survival (OS) (Time Frame - Up to approximately 3 to 6 years):
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.

Studien-Arme

  • Experimental: Cohort A: Ponatinib 30 milligram (mg)
    Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 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 and Days 11 to 14 for up to 3 cycles (each cycle will be of 28-days) in induction phase followed by ponatinib last dose of induction phase 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 Cycles 2, 4, and 6, (cytarabine dose will be reduced/ discontinued in case of impaired renal function) and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (>=60 yrs), IV infusion, on Day 1 of cycles 1, 3, and 5 in consolidation phase followed by ponatinib last dose of consolidation phase, tablets, orally, QD, with vincristine 1.4 mg/m^2, 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.
  • Active Comparator: Cohort B: Imatinib 600 mg
    Imatinib 600 mg,tablets, orally,QD,along 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 through 4 and Days 11 through 14 in each 28-day cycle up to 3 cycles in induction phase followed by imatinib 600 mg,tablets,orally,QD, along 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), (cytarabine dose reduced/discontinued for participant with impaired renal function) 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.

Geprüfte Regime

  • Ponatinib (Iclusig):
    Ponatinib Tablets.
  • Imatinib (Gleevec):
    Imatinib Tablets.
  • Vincristine:
    Vincristine IV injection.
  • Dexamethasone:
    Dexamethasone Tablets.
  • Cytarabine:
    Cytarabine IV infusion.
  • Methotrexate:
    Methotrexate IV infusion.
  • Prednisone:
    Prednisone Tablets.

Quelle: ClinicalTrials.gov


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