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

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

Phase 3 Interventional Alliance for Clinical Trials in Oncology · NCT03150693

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

PhasePhase 3
Study typeInterventional
Enrollment310 (estimated)
Ages18 Years to 39 Years
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionsimatinib, chemotherapy, methotrexate, inotuzumab, rituximab, cyclophosphamide, doxorubicin
Locations460 sites (Birmingham, Alabama and 459 other locations)
Trial IDNCT03150693 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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
* 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: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity
* No prior therapy except for limited treatment (\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine
* 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
* Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
* Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented on case report forms
* Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients with down syndrome are excluded from this study
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
* Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
* Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault

RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)

* Completion of remission induction therapy
* 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
* No ascites, effusions or significant edema
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome
* Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN)
* Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V)
* Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy (Course V)
* Patient is in complete continuous first remission at entry into A041501-HO1
* Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75 mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX dosing based on laboratory or clinical parameters is acceptable)
* Patient is able and willing to use the Medication Event Monitoring System (MEMS) TrackCap (e.g. not using a pillbox)

Where this trial is running

Birmingham, Alabama and 459 other locations

+410 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B Acute Lymphoblastic Leukemia
Last reviewed 2026-06-13 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.