Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 2
Age: 14Years +
All Genders
ID02877303
Phase II Study of Hyper-CVAD with Blinatumomab and Inotuzumab Ozogamicin as Frontline Therapy for Adults with B-Cell Acute Lymphoblastic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
80
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how well a combination of blinatumomab, inotuzumab ozogamicin, and chemotherapy works as an initial treatment for patients with B-cell acute lymphoblastic leukemia (ALL). This phase II trial aims to assess relapse-free survival and other outcomes like overall survival, response rate, and safety using this combined approach. The study also explores genetic factors that may predict treatment response and compares different methods for detecting minimal residual disease. During the intensive phase, patients receive a detailed chemotherapy regimen including drugs like cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, with some receiving additional antibodies like ofatumumab or rituximab. This phase lasts up to four cycles with treatments given on specific days. The next phase includes blinatumomab given continuously for four weeks and inotuzumab ozogamicin administered intravenously on certain days, repeated every six weeks for up to four cycles. A maintenance phase may follow, where patients receive oral and intravenous medications such as mercaptopurine, methotrexate, vincristine, prednisone, and blinatumomab over about 12 months. Participants will have monthly follow-up visits for up to 24 months after completing treatment. Assessments include monitoring for disease relapse, survival, response rates, and side effects. The study also involves laboratory biomarker analysis and genetic testing to understand treatment effects better. Safety and efficacy outcomes will be tracked throughout the study period to evaluate the combination therapy's impact on B-cell ALL.
CONDITIONS
Brief Title
Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
Who Can Participate
Age: 14Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, untreated B-lineage ALL or lymphoblastic lymphoma, or complete remission after one induction chemotherapy course
- Patients may use steroids, cytarabine, or hydrea to manage symptoms before diagnosis and treatment plan finalization
- Failure of 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 history and exam
- No active or co-existing cancer with life expectancy under 12 months as judged by physician
You will not qualify if you...
- Pregnant or nursing women
- Known HIV-positive status
- Philadelphia chromosome-positive ALL
- Active and uncontrolled disease or infection as judged by physician
- Unable or unwilling to sign consent form
- Current active liver or bile disease except Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease
- History or presence of serious central nervous system disorders such as epilepsy, stroke, dementia, Parkinson's disease, or psychosis (patients with CNS leukemia involvement are allowed)
- Current or past autoimmune disease with possible CNS involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Intensive Phase Treatment
Duration - Up to 12 weeks (4 cycles repeated every 3 weeks)
Participants receive combination chemotherapy including cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, cytarabine, and possibly ofatumumab or rituximab over multiple cycles.
Multiple visits during each 3-week cycle for drug administration and monitoring
Blinatumomab and Inotuzumab Ozogamicin Phase
Duration - Up to 24 weeks (4 cycles repeated every 6 weeks)
Participants receive blinatumomab by continuous IV infusion for 4 weeks and inotuzumab ozogamicin IV on specific days during cycles 6 and 8.
Continuous IV infusion for blinatumomab with additional IV infusions for inotuzumab on days 5 and 11 during cycles 6 and 8
Maintenance Phase
Duration - Up to 12 months
Participants may receive maintenance therapy including mercaptopurine, methotrexate, vincristine sulfate, prednisone, and intermittent blinatumomab to prevent disease progression.
Monthly visits for vincristine sulfate administration and blinatumomab infusions after every 3 cycles, plus weekly oral medication monitoring
Follow-up
Duration - Up to 24 months
After completing treatment, participants are monitored monthly to assess long-term outcomes and safety.
Monthly visits for up to 24 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
E
Elias Jabbour
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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Published Research Related To This Trial
Hyper-CVAD and sequential blinatumomab for newly diagnosed Philadelphia chromosome-negative B-cell acute lymphocytic leukaemia: a single-arm, single-centre, phase 2 trial.
Elias Jabbour, Nicholas J Short, Nitin Jain...
https://pubmed.ncbi.nlm.nih.gov/36279879Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia.
Zheng Shi, Yiqian Zhu, Jing Zhang...
https://pubmed.ncbi.nlm.nih.gov/35622074The Hyper-CVAD Regimen is an Optimal Pediatric-inspired Regimen for Adolescents and Adults With Acute Lymphoblastic Leukemia.
Elias Jabbour, Hagop Kantarjian
https://pubmed.ncbi.nlm.nih.gov/33191168