Clinical trial Recruiting at 157 sites Phase 3 Interventional Ages 18 to 39

Inotuzumab ozogamicin with frontline chemotherapy for young adults with B‑cell acute lymphoblastic leukemia

Official title: 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

Run by Alliance for Clinical Trials in Oncology · NCT03150693 · Data updated 2026-11-12

This trial tests whether adding the antibody-drug inotuzumab ozogamicin to a pediatric-style frontline chemotherapy plan helps young adults with newly diagnosed CD22-positive B acute lymphoblastic leukemia live longer without relapse.

More B Acute Lymphoblastic Leukemia trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 39 Years
SexAll
Enrollment303 (estimated)
SponsorAlliance for Clinical Trials in Oncology
Academic / other
Drugs / interventionsimatinib, chemotherapy, inotuzumab, blinatumomab, rituximab, radiation, methotrexate, cyclophosphamide, doxorubicin
Locations460 sites (Birmingham, Alabama and 459 other locations)
StatusRecruiting
StartedSeptember 20, 2017
Main results expectedNovember 1, 2027
Study endsApril 1, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT03150693 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are young adults with newly diagnosed CD22-positive B‑cell ALL who have had no more than limited prior therapy (less than 7 days of steroids or hydroxyurea) and who are not BCR-ABL (Ph+) positive.

Probably not a fit

Patients with Burkitt-type ALL, BCR-ABL (Ph+) positive disease, CD22-negative disease, extensive prior leukemia treatment, or significant comorbidities that preclude the chemotherapy backbone are unlikely to benefit from this regimen.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This partially randomized phase III trial adds inotuzumab ozogamicin to the pediatric-inspired CALGB 10403 chemotherapy backbone for newly diagnosed CD22-positive B‑ALL in young adults. The study monitors tolerability and toxicity of the combination and compares event-free survival, disease-free survival, and overall survival between patients treated with and without inotuzumab. Secondary and exploratory analyses include minimal residual disease (MRD) measurements and correlation with a low-density array (LDA) gene signature to explore biomarkers of benefit. Standard chemotherapy agents used include cytarabine, daunorubicin, vincristine, dexamethasone and supportive agents such as allopurinol.

Why it matters

Potential benefit: If successful, adding inotuzumab ozogamicin could increase rates of deeper remission and improve event-free and overall survival for young adults with CD22-positive B‑ALL.

How similar studies have gone: Inotuzumab ozogamicin has shown higher remission rates and improved MRD negativity in relapsed/refractory B‑ALL, but its benefit when added up front to a pediatric-inspired regimen is less well established.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California, United States
    Recruiting
  • Community Cancer Institute
    Clovis, California, United States
    Recruiting
  • UC Irvine Health Cancer Center-Newport
    Costa Mesa, California, United States
    Recruiting
  • Kaiser Permanente Dublin
    Dublin, California, United States
    Recruiting
  • Kaiser Permanente-Fremont
    Fremont, California, United States
    Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Fresno, California, United States
    Recruiting
Show 44 more locations
  • Kaiser Permanente-Fresno
    Fresno, California, United States
    Recruiting
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
    Irvine, California, United States
    Recruiting
  • Kaiser Permanente- Modesto MOB II
    Modesto, California, United States
    Recruiting
  • Kaiser Permanente-Modesto
    Modesto, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, United States
    Recruiting
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California, United States
    Recruiting
  • Kaiser Permanente-Richmond
    Richmond, California, United States
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California, United States
    Recruiting
  • Kaiser Permanente Downtown Commons
    Sacramento, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-South Sacramento
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-San Francisco
    San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, United States
    Recruiting
  • Kaiser Permanente San Leandro
    San Leandro, California, United States
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California, United States
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, United States
    Recruiting
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Stockton
    Stockton, California, United States
    Recruiting
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California, United States
    Recruiting
  • Kaiser Permanente-Vallejo
    Vallejo, California, United States
    Recruiting
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida, United States
    Recruiting
  • Orlando Health Cancer Institute
    Orlando, Florida, United States
    Recruiting
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia, United States
    Recruiting
  • Augusta University Medical Center
    Augusta, Georgia, United States
    Recruiting
  • Straub Clinic and Hospital
    Honolulu, Hawaii, United States
    Recruiting
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii, United States
    Recruiting
  • Pali Momi Medical Center
    ‘Aiea, Hawaii, United States
    Recruiting
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho, United States
    Recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho, United States
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho, United States
    Recruiting
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho, United States
    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho, United States
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Twin Falls
    Twin Falls, Idaho, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • Rush MD Anderson Cancer Center
    Chicago, Illinois, United States
    Recruiting

+410 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.