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Clinical Trials in Germany / NCT03007147
Active, not recruiting Phase 3

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

NCT03007147 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2017-08-08
Last updated
2026-08-19

Condition(s) studied

Acute Lymphoblastic LeukemiaB Acute Lymphoblastic LeukemiaMixed Phenotype Acute LeukemiaT Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Allogeneic Hematopoietic Stem Cell TransplantationCalaspargase Pegol →Cyclophosphamide →Cytarabine →Daunorubicin Hydrochloride →Dexamethasone →Dexrazoxane Hydrochloride →Doxorubicin →Etoposide →Filgrastim →Ifosfamide →Imatinib Mesylate →Laboratory Biomarker AnalysisLeucovorin Calcium →Levoleucovorin →Mercaptopurine →Mercaptopurine →Methotrexate →Methylprednisolone →Pegaspargase →Prednisolone →Questionnaire AdministrationTherapeutic Hydrocortisone →Thioguanine →Vincristine Sulfate →

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT

Calaspargase Pegol: Given IV

Cyclophosphamide: Given IV

Cytarabine: Given IV, SC, or IT

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given PO or IV

Dexrazoxane Hydrochloride: Given IV

Doxorubicin: Given IV

Etoposide: Given IV

Filgrastim: Given SC or IV

Ifosfamide: Given IV

Imatinib Mesylate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given PO or IV

Levoleucovorin: Given PO or IV

Mercaptopurine: Given PO

Mercaptopurine: Given PO

Methotrexate: Given IT

Methylprednisolone: Given IV

Pegaspargase: Given IV

Prednisolone: Given PO

Questionnaire Administration: Ancillary studies

Therapeutic Hydrocortisone: Given IT

Thioguanine: Given PO

Vincristine Sulfate: Given IV

Study summary

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

Eligibility

Sex
ALL
Min age
1 Year
Max age
21 Years
Healthy volunteers
No
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 RNA-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, California \[CA\], United States of America \[USA\] 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

Primary outcome measure(s)

Trial sites (226)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama
USA Health Strada Patient Care Center Mobile Alabama
Providence Alaska Medical Center Anchorage Alaska
Banner Children's at Desert Mesa Arizona
Phoenix Childrens Hospital Phoenix Arizona
Banner University Medical Center - Tucson Tucson Arizona
Arkansas Children's Hospital Little Rock Arkansas
Kaiser Permanente Downey Medical Center Downey California
City of Hope Comprehensive Cancer Center Duarte California
Loma Linda University Medical Center Loma Linda California
Miller Children's and Women's Hospital Long Beach Long Beach California
Children's Hospital Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Valley Children's Hospital Madera California
UCSF Benioff Children's Hospital Oakland Oakland California
Kaiser Permanente-Oakland Oakland California
Children's Hospital of Orange County Orange California
Lucile Packard Children's Hospital Stanford University Palo Alto California
University of California Davis Comprehensive Cancer Center Sacramento California
Rady Children's Hospital - San Diego San Diego California
UCSF Medical Center-Mission Bay San Francisco California
Children's Hospital Colorado Aurora Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
Connecticut Children's Medical Center Hartford Connecticut
Yale University New Haven Connecticut
Alfred I duPont Hospital for Children Wilmington Delaware
MedStar Georgetown University Hospital Washington D.C. District of Columbia
Children's National Medical Center Washington D.C. District of Columbia
Broward Health Medical Center Fort Lauderdale Florida
Golisano Children's Hospital of Southwest Florida Fort Myers Florida
UF Health Cancer Institute - Gainesville Gainesville Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
Nemours Children's Clinic-Jacksonville Jacksonville Florida
Palms West Radiation Therapy Loxahatchee Groves Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Nicklaus Children's Hospital Miami Florida
Miami Cancer Institute Miami Florida
AdventHealth Orlando Orlando Florida
Arnold Palmer Hospital for Children Orlando Florida
Nemours Children's Hospital Orlando Florida

+ 186 more sites — see the full list on the official registry below.

More Children's Oncology Group trials in Germany

Other trials for the same condition

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 NCT03007147 on ClinicalTrials.gov ↗ ← All trials in Germany