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)
Event-free survival (EFS) — Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years The EFS distributions between the two arms will be compared using non-stratified log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. with diagnostics test on proportional hazard assumptions first. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.
Trial sites (460)
Facility
City
Region
Status
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.
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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