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

RecruitingPhase 3

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

Who can join

Ages 18 to 39 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Alliance for Clinical Trials in Oncology · Participants: 303 · Started: Sep 20, 2017

Contact the study team

Official record on ClinicalTrials.gov — NCT03150693

Locations in the U.S.

CaliforniaKaiser Permanente-Deer Valley Medical Center, Antioch
Community Cancer Institute, Clovis
UC Irvine Health Cancer Center-Newport, Costa Mesa
Kaiser Permanente Dublin, Dublin
Kaiser Permanente-Fremont, Fremont
Kaiser Permanente Fresno Orchard Plaza, Fresno
Kaiser Permanente-Fresno, Fresno
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
Kaiser Permanente- Modesto MOB II, Modesto
Kaiser Permanente-Modesto, Modesto
Kaiser Permanente-Oakland, Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange
Stanford Cancer Institute Palo Alto, Palo Alto
Kaiser Permanente-Richmond, Richmond
Kaiser Permanente-Roseville, Roseville
Kaiser Permanente Downtown Commons, Sacramento
Kaiser Permanente-South Sacramento, Sacramento
University of California Davis Comprehensive Cancer Center, Sacramento
Kaiser Permanente-San Francisco, San Francisco
Kaiser Permanente-Santa Teresa-San Jose, San Jose
Kaiser Permanente San Leandro, San Leandro
Kaiser San Rafael-Gallinas, San Rafael
Kaiser Permanente Medical Center - Santa Clara, Santa Clara
Kaiser Permanente-Santa Rosa, Santa Rosa
Kaiser Permanente-South San Francisco, South San Francisco
Kaiser Permanente-Stockton, Stockton
Kaiser Permanente Medical Center-Vacaville, Vacaville
Kaiser Permanente-Vallejo, Vallejo
Kaiser Permanente-Walnut Creek, Walnut Creek
ConnecticutYale University, New Haven
FloridaMemorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood
Orlando Health Cancer Institute, Orlando
GeorgiaEmory University Hospital/Winship Cancer Institute, Atlanta
Augusta University Medical Center, Augusta
HawaiiKapiolani Medical Center for Women and Children, Honolulu
Straub Clinic and Hospital, Honolulu
Pali Momi Medical Center, ‘Aiea
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Luke's Cancer Institute - Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Luke's Cancer Institute - Fruitland, Fruitland
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Saint Luke's Cancer Institute - Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
Saint Luke's Cancer Institute - Twin Falls, Twin Falls
IllinoisNorthwestern University, Chicago
Rush MD Anderson Cancer Center, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
University of Illinois, Chicago
NorthShore University HealthSystem-Evanston Hospital, Evanston
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
Loyola University Medical Center, Maywood
UC Comprehensive Cancer Center at Silver Cross, New Lenox
University of Chicago Medicine-Orland Park, Orland Park
IowaUniversity of Iowa/Holden Comprehensive Cancer Center, Iowa City
KansasUniversity of Kansas Cancer Center, Kansas City
University of Kansas Hospital-Westwood Cancer Center, Westwood
Cancer Center of Kansas - Wichita, Wichita
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington
MarylandUniversity of Maryland/Greenebaum Cancer Center, Baltimore
MassachusettsDana-Farber Cancer Institute, Boston
Massachusetts General Hospital Cancer Center, Boston
MichiganTrinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Trinity Health Medical Center - Brighton, Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health Medical Center - Canton, Canton
Chelsea Hospital, Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Wayne State University/Karmanos Cancer Institute, Detroit
Weisberg Cancer Treatment Center, Farmington Hills
Cancer Hematology Centers - Flint, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Beacon Kalamazoo Cancer Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Henry Ford Saint John Hospital - Macomb Medical, Macomb
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
Corewell Health Reed City Hospital, Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Munson Medical Center, Traverse City
University of Michigan Health - West, Wyoming
Huron Gastroenterology PC, Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaEssentia Health Cancer Center, Duluth
Abbott-Northwestern Hospital, Minneapolis
Mayo Clinic in Rochester, Rochester
MissouriSiteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
NevadaOptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
New YorkRoswell Park Cancer Institute, Buffalo
Northwell Health/Center for Advanced Medicine, Lake Success
North Shore University Hospital, Manhasset
Long Island Jewish Medical Center, New Hyde Park
Mount Sinai Hospital, New York
NYP/Weill Cornell Medical Center, New York
University of Rochester, Rochester
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
East Carolina University, Greenville
Wake Forest University Health Sciences, Winston-Salem
OhioUniversity of Cincinnati Cancer Center-UC Medical Center, Cincinnati
Case Western Reserve University, Cleveland
Cleveland Clinic Foundation, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
University of Cincinnati Cancer Center-West Chester, West Chester
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonProvidence Newberg Medical Center, Newberg
Saint Alphonsus Cancer Care Center-Ontario, Ontario
Oregon Health and Science University, Portland
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Lehigh Valley Hospital - Muhlenberg, Bethlehem
Thomas Jefferson University Hospital, Philadelphia
University of Pennsylvania/Abramson Cancer Center, Philadelphia
Rhode IslandRhode Island Hospital, Providence
South CarolinaPrisma Health Cancer Institute - Spartanburg, Boiling Springs
Prisma Health Richland Hospital, Columbia
Prisma Health Cancer Institute - Easley, Easley
Prisma Health Cancer Institute - Butternut, Greenville
Prisma Health Cancer Institute - Eastside, Greenville
Prisma Health Cancer Institute - Faris, Greenville
Prisma Health Greenville Memorial Hospital, Greenville
Saint Francis Cancer Center, Greenville
Saint Francis Hospital, Greenville
Prisma Health Cancer Institute - Greer, Greer
Prisma Health Cancer Institute - Seneca, Seneca
TexasHouston Methodist Hospital, Houston
UtahHuntsman Cancer Institute/University of Utah, Salt Lake City
VirginiaVCU Massey Comprehensive Cancer Center, Richmond
WashingtonSwedish Cancer Institute-Edmonds, Edmonds
Swedish Medical Center-First Hill, Seattle
WisconsinUniversity of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Marshfield Medical Center-Marshfield, Marshfield
Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.