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Blinatumomab, Inotuzumab Ozogamicin, and Chemotherapy for B Acute Lymphoblastic Leukemia

This study is looking at how well a combination of treatments works for people with newly diagnosed B acute lymphoblastic leukemia (a type of blood cancer) or lymphoblastic lymphoma. The treatments include blinatumomab and inotuzumab ozogamicin, which are immunotherapy drugs (they use your body's immune system to fight cancer), along with standard chemotherapy drugs like cyclophosphamide, cytarabine, dexamethasone, and doxorubicin hydrochloride. Blinatumomab helps your immune system target cancer cells. Inotuzumab ozogamicin delivers a toxic agent directly to CD22 positive cancer cells to kill them. The study aims to see how long people live without their cancer returning (relapse-free survival) for up to 24 months. Participants must be 14 years or older and have newly diagnosed B-lineage ALL or lymphoblastic lymphoma, or have achieved complete remission after one round of chemotherapy. The current status of this study is unclear.

Study design
This is a Phase II interventional study, meaning it tests if a new treatment works and is safe. It plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of treatment until death or disease relapse, for up to 24 months.

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

NCT02877303

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia

Recruiting
PHASE2Ages 14+InterventionalTreatment
M.D. Anderson Cancer Center
~80 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:BlinatumomabCyclophosphamideCytarabineDexamethasoneDoxorubicin HydrochlorideInotuzumab Ozogamicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relapse-free survival (RFS)
Measured over From date of treatment start until the date of death or disease relapse, assessed for up to 24 months

Conditions

B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma

Explore related trials

B Acute Lymphoblastic LeukemiaB Lymphoblastic LymphomaCD22 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Elias Jabbour · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Elias Jabbour
[email protected]
713-792-4764
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with newly diagnosed, previously untreated B-lineage ALL or lymphoblastic lymphoma, or having achieved complete remission (CR) with one course of induction chemotherapy; patients who require steroids, cytarabine (ara-c) or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible
Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible
Performance status of 0-3
Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
Adequate cardiac function as assessed by history and physical examination
No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record

Exclusion

Pregnant or nursing women
Known to be human immunodeficiency virus (HIV)-positive
Philadelphia chromosome (Ph)-positive ALL
Active and uncontrolled disease/infection as judged by the treating physician, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record
Unable or unwilling to sign the consent form
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per treating physician assessment), sources for the determination of clinical significance by the treating physician will be included in the subject's medical record
History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; (Patients with CNS involvement of leukemia are NOT excluded)
Current autoimmune disease or history of autoimmune disease with potential CNS involvement; auto-immune disease with possible CNS consequences/manifestations such as such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson's disease, cerebellar disease, or psychosis

What this trial measures

  • Relapse-free survival (RFS)From date of treatment start until the date of death or disease relapse, assessed for up to 24 months

    Will be estimated using the method of Kaplan and Meier. Will compute the Bayesian posterior probability. Will perform a competing risk analysis treating stem cell transplant as a competing event for RFS.