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Clinical Trials in Canada / NCT02101853
Active, not recruiting Phase 3

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

NCT02101853 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2014-12-17
Last updated
2026-07-29

Condition(s) studied

Recurrent B Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Allogeneic Hematopoietic Stem Cell TransplantationAsparaginase →Blinatumomab →Cyclophosphamide →Cytarabine →Dexamethasone →Etoposide →Leucovorin Calcium →Mercaptopurine →Methotrexate →Mitoxantrone →Mitoxantrone Hydrochloride →Pegaspargase →Pharmacological StudyRadiation TherapyTherapeutic Hydrocortisone →Thioguanine →Vincristine →Vincristine Sulfate →

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HSCT

Asparaginase: Given IM or IV

Blinatumomab: Given IV

Cyclophosphamide: Given IV

Cytarabine: Given IT and IV or SC

Dexamethasone: Given PO or IV

Etoposide: Given IV

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, IV, and PO

Mitoxantrone: Given IV

Mitoxantrone Hydrochloride: Given IV

Pegaspargase: Given IV

Pharmacological Study: Correlative studies

Radiation Therapy: Undergo cranial radiation therapy

Therapeutic Hydrocortisone: Given IT

Thioguanine: Given PO

Vincristine: Given IV

Vincristine Sulfate: Given IV

Study summary

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Eligibility

Sex
ALL
Min age
1 Year
Max age
31 Years
Healthy volunteers
No
Inclusion Criteria: * Patients \>= 1 year and \< 31 years of age at the time of relapse will be eligible * First relapse of B-ALL, allowable sites of disease include isolated bone marrow, combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular; extramedullary sites are limited to the CNS and testicles * No waiting period for patients who relapse while receiving standard maintenance therapy * Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy (methotrexate strongly preferred) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status * Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur * Stem cell transplant or rescue: patient has not had a prior stem cell transplant or rescue * Patient has not had prior treatment with blinatumomab * With the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of first relapse) * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows: * 1 to \< 2 years: =\< 0.6 mg/dL * 2 to \< 6 years: =\< 0.8 mg/dL * 6 to \< 10 years: =\< 1 mg/dL * 10 to \< 13 years: =\< 1.2 mg/dL * 13 to \< 16 years: =\< 1.5 mg/dL (males) and =\< 1.4 mg/dL (females) * \>= 16 years: =\< 1.7 mg/dL (males) and =\< 1.4 mg/dL (females) * Direct bilirubin \< 3.0 mg/dL * Shortening fraction of \>= 27% by echocardiogram, or * Ejection fraction of \>= 50% by radionuclide angiogram * All patients and/or their parent or legal guardian must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible * Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not eligible * Patients with B-lymphoblastic lymphoma (B-LL) are not eligible * Patients with known optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement * Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome * Patients with known human immunodeficiency virus (HIV) infection * Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and etoposide phosphate (Etopophos) * Lactating females who plan to breastfeed * 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 * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation * Patients with pre-existing significant central nervous system pathology that would preclude treatment with blinatumomab, including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible; patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved) * Patients with uncontrolled seizure disorder are not eligible; (patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs remain eligible)

Primary outcome measure(s)

Trial sites (186)

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
Mattel Children's Hospital UCLA 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
UCSF Medical Center-Mission Bay San Francisco California
Santa Barbara Cottage Hospital Santa Barbara 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
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
AdventHealth Orlando Orlando Florida
Arnold Palmer Hospital for Children Orlando Florida

+ 146 more sites — see the full list on the official registry below.

More National Cancer Institute (NCI) trials in Canada

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 NCT02101853 on ClinicalTrials.gov ↗ ← All trials in Canada