🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Canada / NCT03150693
Recruiting Phase 3

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

NCT03150693 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2017-09-20
Last updated
2026-09-02

Condition(s) studied

B Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Allopurinol →Cytarabine →Daunorubicin Hydrochloride →Vincristine Sulfate →Dexamethasone →Pegylated L-AsparaginaseMethotrexate →Bone Marrow Aspiration and BiopsyCyclophosphamide →Mercaptopurine →Rituximab →Doxorubicin →Thioguanine →Inotuzumab Ozogamicin →Laboratory Biomarker Analysis

Allopurinol: Given PO

Cytarabine: Given IT, IV, SC

Daunorubicin Hydrochloride: Given IV

Vincristine Sulfate: Given IV

Dexamethasone: Given PO or IV

Pegylated L-Asparaginase: Given IV

Methotrexate: Given IT, IV, PO

Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy

Cyclophosphamide: Given IV

Mercaptopurine: Given PO

Rituximab: Given IV

Doxorubicin: Given IV

Thioguanine: Given PO

Inotuzumab Ozogamicin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Study summary

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \[intervention\], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria: REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized * Rating: M0, M1; Blast Cells (%): 0-5.0 * Rating: M2; Blast Cells (%): 5.1-25.0 * Rating: M3; Blast Cells (%): \> 25-50 * Rating: M4; Blast Cells (%): \> 50.0 * The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) \>= 750/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count \>= 75,000/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN) EXCLUSION CRITERIA * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 8 days prior to registration is required * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist

Primary outcome measure(s)

Trial sites (460)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Active Not Recruiting
Anchorage Associates in Radiation Medicine Anchorage Alaska Suspended
Anchorage Radiation Therapy Center Anchorage Alaska Suspended
Alaska Breast Care and Surgery LLC Anchorage Alaska Suspended
Alaska Oncology and Hematology LLC Anchorage Alaska Suspended
Alaska Women's Cancer Care Anchorage Alaska Suspended
Anchorage Oncology Centre Anchorage Alaska Suspended
Katmai Oncology Group Anchorage Alaska Suspended
Providence Alaska Medical Center Anchorage Alaska Suspended
Fairbanks Memorial Hospital Fairbanks Alaska Suspended
Kingman Regional Medical Center Kingman Arizona Suspended
Mayo Clinic Hospital in Arizona Phoenix Arizona Suspended
Mayo Clinic in Arizona Scottsdale Arizona Withdrawn
Mercy Hospital Fort Smith Fort Smith Arkansas Suspended
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
PCR Oncology Arroyo Grande California Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Suspended
Community Cancer Institute Clovis California Recruiting
University Oncology Associates Clovis California Suspended
UC Irvine Health Cancer Center-Newport Costa Mesa California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Fresno Cancer Center Fresno California Suspended
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
Kaiser Permanente- Modesto MOB II Modesto California Recruiting
Kaiser Permanente-Modesto Modesto California Recruiting
Kaiser Permanente Oakland-Broadway Oakland California Suspended
Kaiser Permanente-Oakland Oakland California Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California Recruiting
Stanford Cancer Institute Palo Alto Palo Alto California Recruiting
Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California Suspended
Kaiser Permanente- Marshall Medical Offices Redwood City California Suspended
Kaiser Permanente-Redwood City Redwood City California Suspended
Kaiser Permanente-Richmond Richmond California Recruiting
Rohnert Park Cancer Center Rohnert Park California Suspended
Kaiser Permanente-Roseville Roseville California Recruiting
The Permanente Medical Group-Roseville Radiation Oncology Roseville California Suspended
Kaiser Permanente Downtown Commons Sacramento California Recruiting

+ 420 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

More Alliance for Clinical Trials in Oncology 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 NCT03150693 on ClinicalTrials.gov ↗ ← All trials in Canada