Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients) — 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.
Trial sites (226)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
Other trials for the same condition
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 Sweden