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JOURNAL ONKOLOGIE – STUDIE

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Rekrutierend

NCT-Nummer:
NCT03007147

Studienbeginn:
August 2017

Letztes Update:
11.04.2024

Wirkstoff:
Calaspargase Pegol, Cyclophosphamide, Cytarabine, Daunorubicin hydrochloride, Dexamethasone, Dexrazoxane Hydrochloride, Doxorubicin, Etoposide, Filgrastim, ifosfamide, Imatinib Mesylate, Leucovorin Calcium, Mercaptopurine, Methotrexate, Methylprednisolone, Pegaspargase, prednisolone, Therapeutic Hydrocortisone, Thioguanine, Vincristine sulfate

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

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Children's Oncology Group

Collaborator:
EsPhALL Network/ BFM Study Group, National Cancer Institute (NCI),

Studienleiter

Lewis B Silverman
Principal Investigator
Children's Oncology Group
Prof. Andrea Biondi
Principal Investigator
EsPhALL Network/ BFM Study Group

Studienlocations
(3 von 227)

University Medical Center chleswig- Campus Kiel
24105 Kiel
(Schleswig-Holstein)
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Dr. M. Schrappe
Phone: 49(0) 431-500 20100/20102
E-Mail: m.schrappe@pediatrics.uni-kiel.de

Dr. G. Cairo
Phone: 49(0) 431-500 20100/20102
E-Mail: Gunnar.Cario@uksh.de» Ansprechpartner anzeigen
Providence Alaska Medical Center
99508 Anchorage
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Phone: 907-212-6871
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94304 Palo Alto
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MedStar Georgetown University Hospital
20007 Washington
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20010 Washington
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33908 Fort Myers
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University of Florida Health Science Center - Gainesville
32610 Gainesville
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
33021 Hollywood
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Palms West Radiation Therapy
33470 Loxahatchee Groves
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University of Miami Miller School of Medicine-Sylvester Cancer Center
33136 Miami
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33607 Tampa
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31404 Savannah
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60637 Chicago
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Tufts Children's Hospital
02111 Boston
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01655 Worcester
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48236 Detroit
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Helen DeVos Children's Hospital at Spectrum Health
49503 Grand Rapids
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Mayo Clinic in Rochester
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89135 Las Vegas
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08903 New Brunswick
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University of New Mexico Cancer Center
87102 Albuquerque
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Phone: 505-925-0348
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
10032 New York
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New York Medical College
10595 Valhalla
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UNC Lineberger Comprehensive Cancer Center
27599 Chapel Hill
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Duke University Medical Center
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58122 Fargo
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ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
43606 Toledo
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Dell Children's Medical Center of Central Texas
78723 Austin
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UT Southwestern/Simmons Cancer Center-Dallas
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Cook Children's Medical Center
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
77030 Houston
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Methodist Children's Hospital of South Texas
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University of Texas Health Science Center at San Antonio
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University of Virginia Cancer Center
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Providence Sacred Heart Medical Center and Children's Hospital
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Saint Vincent Hospital Cancer Center Green Bay
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Princess Margaret Hospital for Children
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Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM
20900 Monza
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Phone: 39-039-233 6816/3513
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Princess Máxima Center for Pediatric Oncology
3584 CT Utrecht
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HIMA San Pablo Oncologic Hospital
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San Jorge Children's Hospital
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Alle anzeigen

Studien-Informationen

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare disease-free survival (DFS) of standard risk (SR) pediatric Philadelphia

chromosome (Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate

(imatinib) combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy

backbone or the more intensive European (Es)PhALL chemotherapy backbone.

SECONDARY OBJECTIVES:

I. To compare DFS of SR pediatric Ph+ and ABL-class fusion positive ALL patients treated with

continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the

more intensive EsPhALL chemotherapy backbone.

II. To determine the feasibility of administration of imatinib after allogeneic hematopoietic

stem cell transplantation (HSCT) in high risk Ph+ ALL patients.

III. To determine event-free survival (EFS) of HR pediatric Ph+ ALL patients treated with

EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.

IV. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients

between the two randomized arms.

V. To evaluate event free survival (EFS) and overall survival (OS) of all eligible Ph+ALL

patients enrolled on the study.

VI. To evaluate OS in SR Ph+ ALL patients. VII. To evaluate OS in HR Ph+ ALL patients. VIII.

To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the

study.

EXPLORATORY OBJECTIVES:

I. To describe the toxicities associated with post-HSCT administration of imatinib in HR

Ph+ALL patients.

II. To evaluate the long-term toxicities in SR Ph+ ALL patients treated with chemotherapy

plus imatinib (no transplant), overall and between both randomized arms.

III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at

various time points during therapy.

IIIa. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals

post-HSCT and explore the association of these measurements with long-term outcome.

IIIb. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase

chain reaction (PCR) assay and next generation sequencing (NGS) assays.

IV. To determine prognostic significance of IKZF1 gene aberrations and deletions in Ph+ ALL.

V. To determine frequency and prognostic significance of p190 and p210 BCR-ABL1 fusion

variants in pediatric Ph+ ALL.

VI. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine, and

methotrexate) during the maintenance phase in SR Ph+ ALL patients.

VIa. To identify factors associated with poor adherence. VIb. To determine association

between relapse risk and adherence to each oral chemotherapeutic agent (separately and

combined).

VII. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and

identify factors associated with poor adherence.

VIII. To compare DFS of SR ABL-class fusion positive ALL patients treated with continuous

imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive

EsPhALL chemotherapy backbone.

OUTLINE:

INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days

1-14.

INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice

daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone

intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22,

daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate

intrathecally (IT) on day 29.

INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide

IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or

subcutaneously (SC) on days 3-6, 10-13, 17-20, and 24-27, and methotrexate IT on days 10 and

24.

POST-INDUCTION THERAPY: Patients classified as standard risk are randomized to 1 of 2 arms.

Patients with high risk are assigned to Arm C.

ARM A:

CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21,

methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose

methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6,

dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4,

leucovorin calcium PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and

pegaspargase or calaspargase pegol IV over 1-2 hours on day 5, and filgrastim SC on days 7-11

in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21,

methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose

methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine

sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin

calcium PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 5-15 minutes and

daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase or calaspargase pegol

IV over 1-2 hours on day 6, and filgrastim SC on days 7-11 in the absence of disease

progression or unexpected toxicity.

CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high

dose cytarabine IV over 3 hours on days 1-3, dexamethasone PO BID or IV on days 1-5,

etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic

hydrocortisone IT on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6,

and filgrastim SC on days 7-11 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days

1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine

sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV

over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over

1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63,

cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV

over 1-30 minutes or SC on days 38-41 and 45-48, and methotrexate IT on days 38 and 45in the

absence of disease progression or unexpected toxicity.

INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28,

methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence

of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days

1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine

sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV

over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over

1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49,

cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV

over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the

absence of disease progression or unexpected toxicity.

MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO

once weekly (QW) and IT on days 1 and 43 of cycles 1, 2, and 3, and mercaptopurine PO on days

1-84. Cycles with imatinib mesylate and mercaptopurine repeat every 84 days for up to 104

weeks from the start of Induction IA in the absence of disease progression or unexpected

toxicity.

ARM B:

INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63,

vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1,

15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,

mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of

disease progression or unexpected toxicity.

DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28,

methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine

sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV

over 1-15 minutes on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2

hours or IM on day 4 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56,

cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV

over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36,

vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase or calaspargase

pegol IV over 1-2 hours on day 43 in the absence of disease progression or unexpected

toxicity.

INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or

BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes

on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or

calaspargase pegol IV over 1-2 hours on days 2 and 22 in the absence of disease progression

or unexpected toxicity.

MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine

sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV

for cycle 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84,

methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for cycle 1 and 2). Cycles

repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of

disease progression or unexpected toxicity.

ARM C:

CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine,

therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone,

leucovorin calcium, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A

Consolidation Block 1, and filgrastim SC on day 7 in the absence of disease progression or

unexpected toxicity.

CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine,

therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate,

ifosfamide, leucovorin calcium, dexrazoxane hydrochloride, daunorubicin hydrochloride,

pegaspargase or calaspargase pegol, and filgrastim as Arm A Consolidation Block 2 in the

absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide,

methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase or calaspargase pegol, and

filgrastim as in Arm A Consolidation Block 3, and high dose cytarabine IV over 3 hours on

days 1-2 in the absence of disease progression or unexpected toxicity.

HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed

Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm

A.

POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in

the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every year for 3 years.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required

diagnostic bone marrow sample has been fulfilled

- For patients who have not previously enrolled on APEC14B1 prior to enrollment on

AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if

marrow sample unavailable) must be available to develop an MRD probe

- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or

ABL-class fusion must be submitted for rapid central review within 72 hours of

study enrollment

- >= 1 year (365 days) and =< 21 years at ALL diagnosis

- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed

phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]

definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in

situ hybridization (FISH) and/or molecular methodologies

- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.

ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,

CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization

(FISH, e.g. using break-apart or colocalization signals probes), multiplex or

singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole

transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA

Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)

- Ph+ patients must have previously started Induction therapy, which includes

vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or

other standard cytotoxic chemotherapy

- Ph+ patients have not received more than 14 days of multiagent Induction therapy

beginning with the first dose of vinCRIStine

- Ph+ patients may have started imatinib prior to study entry but have not received more

than 14 days of imatinib

- ABL-class fusion patients must have previously completed the 4 or 5 weeks of

multiagent Induction chemotherapy (Induction IA phase)

- ABL-class fusion patients may have started imatinib during Induction IA, at the same

time of or after the first vinCRIStine dose

- Patients must have a performance status corresponding to Eastern Cooperative Oncology

Group (ECOG) scores of 0, 1, or 2

- Direct bilirubin =< 2.0 mg/dL

- Shortening fraction of >= 27% by echocardiogram

- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram

- Corrected QT interval, QTc < 480 msec

- Note: Repeat echocardiogram and electrocardiogram are not required if they were

performed at or after initial ALL diagnosis, before study enrollment

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70

mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as

follows:

- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)

- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)

- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)

- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)

- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)

- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

Exclusion Criteria:

- Known history of chronic myelogenous leukemia (CML)

- ALL developing after a previous cancer treated with cytotoxic chemotherapy

- Active, uncontrolled infection, or active systemic illness that requires ongoing

vasopressor support or mechanical ventilation

- Down syndrome

- Pregnancy and breast feeding

- Female patients who are pregnant since fetal toxicities and teratogenic effects

have been noted for several of the study drugs; a pregnancy test is required for

female patients of childbearing potential

- Lactating females who plan to breastfeed their infants

- Sexually active patients of reproductive potential who have not agreed to use an

effective contraceptive method for the duration of treatment according to

protocol

- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart

block

- Prior treatment with dasatinib, or any TKI other than imatinib

Studien-Rationale

Primary outcome:

1. Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients) (Time Frame - Up to 3 years):
Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.



Secondary outcome:

1. DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients) (Time Frame - Up to 3 years):
Three-year DFS (time from randomization to relapse, second malignancy, or death in complete remission) and 95% CI of SR pediatric Ph+ and ABL-class fusion positive patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

2. Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients (Time Frame - Up to 2 years):
The proportion of patients who receive at least 75% of intended doses.

3. Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate (Time Frame - Up to 3 years):
Three-year EFS and 95% CI for high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate. EFS is defined as the time from the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event (resistant disease [MRD >= 10-2 or morphologic residual disease at end of consolidation block 3], relapse, progressive disease [i.e., MRD >= 10-2 at two post-HSCT time points separated by at least 2 weeks], second malignancy, or death in complete remission), or time to last follow-up for patients without events.

4. Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms (Time Frame - Up to 3 years):
Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The rate of infections during the post IB/pre-maintenance phases of treatment will be described for each randomization group.

5. EFS of all Ph+ patients (Time Frame - Up to 3 years):
Three-year EFS and 95% CI for Ph+ ALL patients. EFS here is defined as the time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignant, or death, whichever occurs first.

6. Overall survival (OS) of all Ph+ patients (Time Frame - Up to 3 years):
Three-year OS and 95% CI for Ph+ ALL patients. OS is defined as the time from study enrollment to death from any cause.

7. OS of SR Ph+ patients (Time Frame - Up to 3 years):
Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients

8. OS of SR Ph+ patients by randomization group (Time Frame - Up to 3 years):
Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients by randomization group: treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

9. OS of high risk Ph+ patients (Time Frame - Up to 3 years):
Three-year OS (time from the date of MRD assessment at end-IB to death from any cause) and 95% CI of HR pediatric Ph+ patients.

10. EFS of all eligibility ABL-class fusion positive ALL patients (Time Frame - Up to 3 years):
Three-year EFS (time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignancy, or death, whichever occurs first) and 95% CI of ABL-class fusion positive patients.

11. OS of all eligibility ABL-class fusion positive ALL patients (Time Frame - Up to 3 years):
Three-year OS (the time from study enrollment to death from any cause) and 95% CI of ABL-class fusion positive patients.

Studien-Arme

  • Experimental: Arm A (imatinib mesylate, EsPhALL chemotherapy)
    See Detailed Description
  • Experimental: Arm B (imatinib mesylate, COG/BFM chemotherapy)
    See Detailed Description.
  • Experimental: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
    See Detailed Description

Geprüfte Regime

  • Allogeneic Hematopoietic Stem Cell Transplantation (Allogeneic / Allogeneic Hematopoietic Cell Transplantation / Allogeneic Stem Cell Transplantation / HSC / HSCT / Stem Cell Transplantation, Allogeneic / ):
    Undergo HSCT
  • Calaspargase Pegol (Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl) / Asparlas / Calaspargase Pegol-mknl / EZN-2285 / SC-PEG E. Coli L-Asparaginase / Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase / ):
    Given IV
  • Cyclophosphamide ((-)-Cyclophosphamide / 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate / Asta B 518 / B-518 / Carloxan / Ciclofosfamida / Ciclofosfamide / Cicloxal / Clafen / Claphene / CP monohydrate / CTX / CYCLO-cell / Cycloblastin / Cycloblastine / Cyclophospham / Cyclophosphamid monohydrate / Cyclophosphamide Monohydrate / Cyclophosphamidum / Cyclophosphan / Cyclophosphane / Cyclophosphanum / Cyclostin / Cyclostine / Cytophosphan / Cytophosphane / Cytoxan / Fosfaseron / Genoxal / Genuxal / Ledoxina / Mitoxan / Neosar / Revimmune / Syklofosfamid / WR- 138719 / WR-138719 / ):
    Given IV
  • Cytarabine (.beta.-Cytosine arabinoside / 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone / 1-.beta.-D-Arabinofuranosylcytosine / 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone / 1-Beta-D-arabinofuranosylcytosine / 1.beta.-D-Arabinofuranosylcytosine / 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl- / 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl- / Alexan / Ara-C / ARA-cell / Arabine / Arabinofuranosylcytosine / Arabinosylcytosine / Aracytidine / Aracytin / Aracytine / Beta-Cytosine Arabinoside / CHX-3311 / Cytarabinum / Cytarbel / Cytosar / Cytosine Arabinoside / Cytosine-.beta.-arabinoside / Cytosine-beta-arabinoside / Erpalfa / Starasid / Tarabine PFS / U 19920 / U-19920 / Udicil / WR-28453 / ):
    Given IV, SC, or IT
  • Daunorubicin Hydrochloride (Cerubidin / Cerubidine / Cloridrato de Daunorubicina / Daunoblastin / Daunoblastina / Daunoblastine / Daunomycin Hydrochloride / Daunomycin, hydrochloride / Daunorubicin.HCl / Daunorubicini Hydrochloridum / FI-6339 / Ondena / RP-13057 / Rubidomycin Hydrochloride / Rubilem / ):
    Given IV
  • Dexamethasone (Aacidexam / Adexone / Aknichthol Dexa / Alba-Dex / Alin / Alin Depot / Alin Oftalmico / Amplidermis / Anemul mono / Auricularum / Auxiloson / Baycadron / Baycuten / Baycuten N / Cortidexason / Cortisumman / Decacort / Decadrol / Decadron / Decadron DP / Decalix / Decameth / Decasone R.p. / Dectancyl / Dekacort / Deltafluorene / Deronil / Desamethasone / Desameton / Dexa-Mamallet / Dexa-Rhinosan / Dexa-Scheroson / Dexa-sine / Dexacortal / Dexacortin / Dexafarma / Dexafluorene / Dexalocal / Dexamecortin / Dexameth / Dexamethasone Intensol / Dexamethasonum / Dexamonozon / Dexapos / Dexinoral / Dexone / Dinormon / Dxevo / Fluorodelta / Fortecortin / Gammacorten / Hemady / Hexadecadrol / Hexadrol / Lokalison-F / Loverine / Methylfluorprednisolone / Millicorten / Mymethasone / Orgadrone / Spersadex / TaperDex / Visumetazone / ZoDex / ):
    Given PO or IV
  • Dexrazoxane Hydrochloride (Cardioxane / Totect / Zinecard / ):
    Given IV
  • Doxorubicin (Adriablastin / Hydroxydaunomycin / Hydroxyl Daunorubicin / Hydroxyldaunorubicin / ):
    Given IV
  • Etoposide (Demethyl Epipodophyllotoxin Ethylidine Glucoside / EPEG / Lastet / Toposar / Vepesid / VP 16 / VP 16-213 / VP 16213 / VP-16 / VP-16-213 / VP16 / ):
    Given IV
  • Filgrastim (Filgrastim Biosimilar Filgrastim-sndz / Filgrastim Biosimilar Tbo-filgrastim / Filgrastim XM02 / Filgrastim-aafi / Filgrastim-ayow / Filgrastim-sndz / G-CSF / Granix / Neupogen / Neutroval / Nivestym / r-metHuG-CSF / Recombinant Methionyl Human Granulocyte Colony Stimulating Factor / Releuko / rG-CSF / Tbo-filgrastim / Tevagrastim / XM02 / Zarxio / ):
    Given IV
  • Ifosfamide (Asta Z 4942 / Asta Z-4942 / Cyfos / Holoxan / Holoxane / Ifex / IFO / IFO-Cell / Ifolem / Ifomida / Ifomide / Ifosfamidum / Ifoxan / IFX / Iphosphamid / Iphosphamide / Iso-Endoxan / Isoendoxan / Isophosphamide / Mitoxana / MJF 9325 / MJF-9325 / Naxamide / Seromida / Tronoxal / Z 4942 / Z-4942 / ):
    Given IV
  • Imatinib Mesylate (CGP 57148 / CGP57148B / Gleevec / Glivec / STI 571 / STI-571 / STI571 / ):
    Given PO
  • Laboratory Biomarker Analysis:
    Correlative studies
  • Leucovorin Calcium (Adinepar / Calcifolin / Calcium (6S)-Folinate / Calcium Folinate / Calcium Leucovorin / Calfolex / Calinat / Cehafolin / Citofolin / Citrec / Citrovorum Factor / Cromatonbic Folinico / Dalisol / Disintox / Divical / Ecofol / Emovis / Factor, Citrovorum / Flynoken A / Folaren / Folaxin / FOLI-cell / Foliben / Folidan / Folidar / Folinac / Folinate Calcium / Folinic acid / Folinic Acid Calcium Salt Pentahydrate / Folinoral / Folinvit / Foliplus / Folix / Imo / Lederfolat / Lederfolin / Leucosar / leucovorin / Rescufolin / Rescuvolin / Tonofolin / Wellcovorin / ):
    Given PO or IV
  • Mercaptopurine (3H-Purine-6-thiol / 6 MP / 6 Thiohypoxanthine / 6 Thiopurine / 6-Mercaptopurine / 6-Mercaptopurine Monohydrate / 6-MP / 6-Purinethiol / 6-Thiopurine / 6-Thioxopurine / 6H-Purine-6-thione, 1,7-dihydro- (9CI) / 7-Mercapto-1,3,4,6-tetrazaindene / Alti-Mercaptopurine / Azathiopurine / Bw 57-323H / Flocofil / Ismipur / Leukerin / Leupurin / Mercaleukim / Mercaleukin / Mercaptina / Mercaptopurinum / Mercapurin / Mern / NCI-C04886 / Puri-Nethol / Purimethol / Purine, 6-mercapto- / Purine-6-thiol (8CI) / Purine-6-thiol, monohydrate / Purinethiol / Purinethol / U-4748 / WR-2785 / ):
    Given PO
  • Mercaptopurine (3H-Purine-6-thiol / 6 MP / 6 Thiohypoxanthine / 6 Thiopurine / 6-Mercaptopurine / 6-Mercaptopurine Monohydrate / 6-MP / 6-Purinethiol / 6-Thiopurine / 6-Thioxopurine / 6H-Purine-6-thione, 1,7-dihydro- (9CI) / 7-Mercapto-1,3,4,6-tetrazaindene / Alti-Mercaptopurine / Azathiopurine / Bw 57-323H / Flocofil / Ismipur / Leukerin / Leupurin / Mercaleukim / Mercaleukin / Mercaptina / Mercaptopurinum / Mercapurin / Mern / NCI-C04886 / Puri-Nethol / Purimethol / Purine, 6-mercapto- / Purine-6-thiol (8CI) / Purine-6-thiol, monohydrate / Purinethiol / Purinethol / U-4748 / WR-2785 / ):
    Given PO
  • Methotrexate (Abitrexate / Alpha-Methopterin / Amethopterin / Brimexate / CL 14377 / CL-14377 / Emtexate / Emthexat / Emthexate / Farmitrexat / Fauldexato / Folex / Folex PFS / Lantarel / Ledertrexate / Lumexon / Maxtrex / Medsatrexate / Metex / Methoblastin / Methotrexate LPF / Methotrexate Methylaminopterin / Methotrexatum / Metotrexato / Metrotex / Mexate / Mexate-AQ / MTX / Novatrex / Rheumatrex / Texate / Tremetex / Trexeron / Trixilem / WR-19039 / ):
    Given IT
  • Methylprednisolone (Adlone / Caberdelta M / DepMedalone / Depo Moderin / Depo-Nisolone / Duralone / Emmetipi / Esametone / Firmacort / Medlone 21 / Medrate / Medrol / Medrol Veriderm / Medrone / Mega-Star / Meprolone / Methylprednisolonum / Metilbetasone Solubile / Metrocort / Metypresol / Metysolon / Predni-M-Tablinen / Prednilen / Radilem / Sieropresol / Solpredone / Summicort / Urbason / Veriderm Medrol / Wyacort / ):
    Given IV
  • Pegaspargase (L-Asparaginase with Polyethylene Glycol / Oncaspar / Oncaspar-IV / PEG-Asparaginase / PEG-L-Asparaginase / PEG-L-Asparaginase (Enzon - Kyowa Hakko) / PEGLA / Polyethylene Glycol L-Asparaginase / Polyethylene Glycol-L-Asparaginase / ):
    Given IV
  • Prednisolone ((11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione / .delta.1-Hydrocortisone / Adnisolone / Aprednislon / Capsoid / Cortalone / Cortisolone / Dacortin H / Decaprednil / Decortin H / Delta(1)Hydrocortisone / Delta- Cortef / Delta-Cortef / Delta-Diona / Delta-F / Delta-Phoricol / Delta1-dehydro-hydrocortisone / Deltacortril / Deltahydrocortisone / Deltasolone / Deltidrosol / Dhasolone / Di-Adreson-F / Dontisolon D / Estilsona / Fisopred / Frisolona / Gupisone / Hostacortin H / Hydeltra / Hydeltrasol / Klismacort / Kuhlprednon / Lenisolone / Lepi-Cortinolo / Linola-H N / Linola-H-Fett N / Longiprednil / Metacortandralone / Meti Derm / Meticortelone / Opredsone / Panafcortelone / Precortisyl / Pred-Clysma / Predeltilone / Predni-Coelin / Predni-Helvacort / Prednicortelone / Prednisolonum / Prelone / Prenilone / Sterane / ):
    Given PO
  • Questionnaire Administration:
    Ancillary studies
  • Therapeutic Hydrocortisone (Aeroseb-HC / Barseb HC / Barseb-HC / Cetacort / Cort-Dome / Cortef / Cortenema / Cortifan / Cortisol / Cortispray / Cortril / Dermacort / Domolene / Eldecort / Hautosone / Heb-Cort / Hydrocortisone / Hydrocortone / Hytone / Komed-HC / Nutracort / Proctocort / Rectoid / ):
    Given IT
  • Thioguanine (2-Amino 6MP / 2-Amino-1,7-dihydro-6H-purine-6-thione / 2-Amino-6-mercaptopurine / 2-Amino-6-purinethiol / 2-Aminopurin-6-thiol / 2-Aminopurine-6(1H)-thione / 2-Aminopurine-6-thiol / 2-Aminopurine-6-thiol Hemihydrate / 2-Mercapto-6-aminopurine / 6-Amino-2-mercaptopurine / 6-Mercapto-2-aminopurine / 6-Mercaptoguanine / 6-TG / 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI) / BW 5071 / Lanvis / Tabloid / Thioguanine Hemihydrate / Thioguanine Hydrate / Tioguanin / Tioguanine / Wellcome U3B / WR-1141 / X 27 / ):
    Given PO
  • Vincristine Sulfate (Kyocristine / Leurocristine Sulfate / Leurocristine, sulfate / Oncovin / Vincasar / Vincosid / Vincrex / Vincristine, sulfate / ):
    Given IV

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia"

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