Actively Recruiting
Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2025-11-06
80
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.
CONDITIONS
Official Title
Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed or previously untreated B-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma, or in complete remission after one induction chemotherapy course
- Patients who need steroids, cytarabine, or hydrea to manage symptoms before diagnosis and treatment plan
- Patients who failed one induction chemotherapy course (analyzed separately)
- Performance status between 0 and 3
- Creatinine level less than or equal to 2.0 mg/dL unless tumor-related
- Bilirubin level less than or equal to 2.0 mg/dL unless tumor-related
- Adequate heart function based on medical evaluation
- No active or co-existing cancer with life expectancy under 12 months as judged by the doctor
You will not qualify if you...
- Pregnant or nursing women
- Known HIV-positive status
- Philadelphia chromosome positive acute lymphoblastic leukemia
- Active and uncontrolled disease or infection as judged by the doctor
- Unable or unwilling to sign consent form
- Current active liver or bile duct disease except certain stable conditions
- History or presence of serious brain or nervous system disorders (epilepsy, seizures, stroke, dementia, Parkinson's, psychosis), excluding leukemia in the brain
- Current or past autoimmune disease affecting the nervous system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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