Using blinatumomab, inotuzumab ozogamicin, and chemotherapy to treat B acute lymphoblastic leukemia
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
This study is testing a new combination of two immunotherapy drugs and chemotherapy to see if it helps people with newly diagnosed B acute lymphoblastic leukemia live longer and stay cancer-free.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, blinatumomab, inotuzumab, Immunotherapy, methotrexate, cyclophosphamide, doxorubicin, prednisone, ofatumumab, rituximab |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02877303 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of a combination therapy involving blinatumomab, inotuzumab ozogamicin, and standard chemotherapy for patients with newly diagnosed B acute lymphoblastic leukemia (ALL). The study aims to assess relapse-free survival and other efficacy endpoints, including overall survival and minimal residual disease negativity. Participants will receive a regimen of chemotherapy drugs alongside the immunotherapy agents to enhance treatment outcomes. The trial also explores genomic alterations that may predict responses to this combination therapy.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed, untreated B-lineage ALL or lymphoblastic lymphoma.
Not a fit: Patients with active or co-existing malignancies with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve survival rates and reduce relapse in patients with B acute lymphoblastic leukemia.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elias Jabbour — M.D. Anderson Cancer Center
- Study coordinator: Elias Jabbour
- Email: ejabbour@mdanderson.org
- Phone: 713-792-4764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.