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

Launched by M.D. ANDERSON CANCER CENTER · Aug 19, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three treatments—blinatumomab, inotuzumab ozogamicin, and standard chemotherapy—to see how effective they are as the first line of treatment for patients with B Acute Lymphoblastic Leukemia (ALL) or B Lymphoblastic Lymphoma. Blinatumomab and inotuzumab ozogamicin are types of immunotherapy that help the immune system fight cancer by targeting and killing cancer cells. This trial is looking at whether using these treatments together with chemotherapy can work better than chemotherapy alone.

To be eligible for this trial, participants must have recently been diagnosed with B-lineage ALL or lymphoblastic lymphoma and have not yet received treatment, or they may have had one round of chemotherapy and achieved complete remission. Other criteria include being at least 5 years old, having acceptable kidney and liver function, and not having certain other health issues. Participants can expect to receive these treatments and be closely monitored by medical professionals throughout the trial. It's important to note that pregnant or nursing women, as well as those with specific active health conditions, cannot participate. This trial is currently recruiting patients, and it aims to provide new insights into treating this challenging type of leukemia.

Gender

ALL

Eligibility 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