Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Bortezomib: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT, IV, or SC
Daunorubicin: Given IV
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given PO or IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Leucovorin Calcium: Given PO or IV
Mercaptopurine: Give PO
Methotrexate: Given IT, IV, or PO
Pegaspargase: Given IV
Radiation Therapy: Undergo radiation therapy
Thioguanine: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
Study summary
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Eligibility
Primary outcome measure(s)
- Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients — 3 years
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups.
Trial sites (212)
| 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 | |
| Sutter Medical Center Sacramento | Sacramento | California | |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | |
| Rady Children's Hospital - San Diego | San Diego | California | |
| Naval Medical Center -San Diego | San Diego | California | |
| UCSF Medical Center-Mission Bay | San Francisco | California | |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | 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 | |
| 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 |
+ 172 more sites — see the full list on the official registry below.
More National Cancer Institute (NCI) trials in Australia
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 NCT02112916 on ClinicalTrials.gov ↗ ← All trials in Australia