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Inotuzumab Ozogamicin and Chemotherapy for B Acute Lymphoblastic Leukemia

This study is looking at how safe and effective a new treatment approach is for young adults (ages 18-39) with newly diagnosed B acute lymphoblastic leukemia (a type of blood cancer). It combines a standard chemotherapy regimen with a drug called inotuzumab ozogamicin. Inotuzumab ozogamicin is a targeted therapy, meaning it's designed to specifically find and kill cancer cells by attaching to a protein called CD22 on their surface. The study aims to see if adding inotuzumab ozogamicin improves how long patients live without their cancer returning or getting worse (event-free survival). You must have CD-22 positive B-cell acute lymphoblastic leukemia to be eligible. The current status of this study is unclear.

Study design
This is a Phase III interventional study planning to enroll 303 participants. It aims to compare the new treatment combination against a standard chemotherapy regimen.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for up to 3 years after treatment to see how long you remain free of events like cancer progression or recurrence.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03150693

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

Recruiting
PHASE3Ages 18–39InterventionalTreatment
Alliance for Clinical Trials in Oncology
~303 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:AllopurinolCytarabineDaunorubicin HydrochlorideVincristine SulfateDexamethasonePegylated L-Asparaginase

At a glance

Recruiting sites
156 of 460 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS)
Measured over Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years

Conditions

B Acute Lymphoblastic Leukemia

Explore related trials

B Acute Lymphoblastic LeukemiaCD22 GeneMS4A1 Gene

Where it's being run

460 sites across 45 states
Michigan60
California43
Nevada42
Minnesota39
Colorado31
Washington23
Hawaii18
Missouri18

Study leadership

Who to contact

Daniel J. DeAngelo, MD, PhD
[email protected]
617-632-2645
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.