NCT03959085 · Children's Oncology Group
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
What this study is about
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin.
View original scientific description
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
BIOLOGICAL
Blinatumomab
Given IV
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow biopsy
PROCEDURE
Bone Scan
Undergo bone scan
DRUG
Calaspargase Pegol
Given IV
PROCEDURE
Computed Tomography
Undergo CT
DRUG
Cyclophosphamide
Given IV
DRUG
Cytarabine
Given IV, IT, or SC
DRUG
Daunorubicin Hydrochloride
Given IV
DRUG
Dexamethasone
Given PO or IV
DRUG
Doxorubicin Hydrochloride
Given IV
BIOLOGICAL
Inotuzumab Ozogamicin
Given IV
DRUG
Leucovorin Calcium
Given PO or IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Mercaptopurine
Given PO
DRUG
Methotrexate
Given IT or IV
DRUG
Pegaspargase
Given IV or IM
PROCEDURE
Positron Emission Tomography
Undergo PET
DRUG
Prednisolone
Given PO or IV
DRUG
Prednisone
Given PO or IV
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Radiation Therapy
Undergo testicular radiation therapy
RADIATION
Radiation Therapy
Undergo cranial radiation therapy
DRUG
Thioguanine
Given PO
DRUG
Vincristine Sulfate
Given IV
Primary outcome measures
Post-induction 5-year event-free survival (EFS)
Time frame: From study entry to first event (induction failure, induction death, end of induction [EOI] minimal residual disease [MRD] ≥ 5%,EO consolidation [C] MRD ≥ 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years
Will compare in a randomized manner the post-induction 5-year EFS for children and young adults with High Risk (HR) B-cell acute lymphoblastic leukemia (B-ALL) treated with a modified Berlin-Frankfurt-Münster (mBFM) chemo-immunotherapy backbone that includes blinatumomab and replaces Consolidation Part 2 and Delayed Intensification (DI) Part 2 with two blocks of inotuzumab ozogamicin, versus those treated with a full mBFM chemo-immunotherapy backbone that includes blinatumomab and retains Consolidation Part 2 and DI Part 2 without the addition of inotuzumab ozogamicin.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
- APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
- Patients must be \> 365 days and \< 25 years of age
- White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
- Age 1-9.99 years: WBC \>= 50,000/uL
- Age 10-24.99 years: Any WBC
- Age 1-9.99 years: WBC \< 50,000/uL with:
- Testicular leukemia
- CNS leukemia (CNS3)
- Steroid pretreatment.
- White blood cell count (WBC) criteria for patients
Where
- Birmingham, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Mesa, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Downey, California
- Duarte, California
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
And 146 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations