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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Enrollment | 303 (estimated) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | imatinib, chemotherapy, inotuzumab, blinatumomab, rituximab, radiation, methotrexate, cyclophosphamide, doxorubicin |
| Locations | 460 sites (Birmingham, Alabama and 459 other locations) |
| Status | Recruiting |
| Started | September 20, 2017 |
| Main results expected | November 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT03150693 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
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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
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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
- Study coordinator: Daniel J. DeAngelo, MD, PhD
- Email: daniel_deangelo@dfci.harvard.edu
- Phone: 617-632-2645
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using inotuzumab ozogamicin with chemotherapy for high-risk B-cell leukemia
This study is testing if adding a targeted therapy called inotuzumab ozogamicin to standard chemotherapy can help young patients with high-risk B-cell leukemia live longer without their cancer coming back.
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Using blinatumomab, inotuzumab ozogamicin, and chemotherapy to treat B acute lymphoblastic leukemia
This study is testing a new combination of two immunotherapy drugs and chemotherapy to see if it helps people with newly diagnosed B acute lymphoblastic leukemia live longer and stay cancer-free.
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In vivo CAR-T therapy for relapsed or refractory B‑cell leukemias, lymphomas, and multiple myeloma
This trial will try a single in‑body (intravenous) CAR‑T infusion to treat adults with relapsed or refractory B‑cell acute lymphoblastic leukemia, B‑cell non‑Hodgkin lymphoma, or multiple myeloma.
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Full-course immunotherapy for B‑cell acute lymphoblastic leukemia patients who are unfit for or decline chemotherapy
This study will try a full course of sequential immunotherapy with blinatumomab followed by inotuzumab ozogamicin for people with B‑cell ALL who are older, unfit for, have relapsed/refractory disease, or who decline intensive chemotherapy.
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JY231 injection to treat relapsed or refractory B‑cell lymphoma and leukemia
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.