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
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
Sex
ALL
Min age
1 Year
Max age
30 Years
Healthy volunteers
No
Inclusion Criteria:
* T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
* All patients must be \> 1 and \< 31 years of age
* Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV
* Note: a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation \[CD\]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or \> 25% in the bone marrow; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including terminal deoxynucleotidyl transferase (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory
* For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be accepted
* All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:
* Steroid pretreatment: prednisone or methylprednisolone for =\< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =\< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred \> 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility
* Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or
* Pretreatment with hydroxyurea; or
* 600 cGy of chest irradiation, if medically necessary
* Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment
* Pre-existing \>= grade 2 sensory or motor peripheral neurotoxicity
* Uncontrolled seizure disorder
* Diagnosis of Down syndrome (Trisomy 21)
* 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
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* Patient has hypersensitivity to bortezomib, boron, or mannitol
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
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 Canada
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.
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