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Clinical Trials in Canada / NCT02112916
Active, not recruiting Phase 3

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

NCT02112916 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2014-10-04
Last updated
2026-07-29

Condition(s) studied

Adult T Acute Lymphoblastic LeukemiaAnn Arbor Stage II Adult Lymphoblastic LymphomaAnn Arbor Stage II Childhood Lymphoblastic LymphomaAnn Arbor Stage III Adult Lymphoblastic LymphomaAnn Arbor Stage III Childhood Lymphoblastic LymphomaAnn Arbor Stage IV Adult Lymphoblastic LymphomaAnn Arbor Stage IV Childhood Lymphoblastic LymphomaChildhood T Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Bortezomib →Cyclophosphamide →Cytarabine →Daunorubicin →Daunorubicin Hydrochloride →Dexamethasone →Doxorubicin →Doxorubicin Hydrochloride →Etoposide →Hydrocortisone Sodium Succinate →Ifosfamide →Leucovorin Calcium →Mercaptopurine →Methotrexate →Pegaspargase →Radiation TherapyThioguanine →Vincristine →Vincristine Sulfate →

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

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)

Trial sites (212)

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
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

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 NCT02112916 on ClinicalTrials.gov ↗ ← All trials in Canada