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RecruitingPhase 2

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months, 24 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Cycles repeat every 6 weeks for 12 months in the absence of disease progression or unacceptable toxicity."
  • "After completion of study treatment, patients are followed up 1 time each month for up to 24 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests blinatumomab, inotuzumab ozogamicin, and several chemotherapy drugs as early treatment for B acute lymphoblastic leukemia (ALL), a blood cancer. It aims to find out if this treatment may work better than chemotherapy alone. People with B-cell ALL or lymphoblastic lymphoma, a related cancer, may qualify.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed, untreated B-cell ALL or lymphoblastic lymphoma, or have had one first round of chemotherapy that cleared the cancer or did not work.
  • Prior steroids, cytarabine, or hydrea to control symptoms while the diagnosis and treatment plan were being decided are allowed.
  • Have a daily activity score of 0–3, ranging from fully active to needing help with self-care and spending much of the day in bed or a chair.
  • Have creatinine, a measure of kidney function, at 2.0 mg/dL or less, unless the cancer caused the higher level.
  • Have bilirubin, a measure of liver function, at 2.0 mg/dL or less, unless the cancer caused the higher level.
  • Have good enough heart function based on your health history and a physical exam.
  • Have no other active cancer that is expected to shorten your life to less than 12 months.

Who can't join

  • Are pregnant or breastfeeding.
  • Are known to have HIV.
  • Have Philadelphia chromosome-positive ALL, a type with a certain gene change.
  • Have an active illness or infection that is not controlled, as judged by your doctor.
  • Cannot or do not want to sign the study consent form.
  • Have active liver or bile duct disease. Exceptions include Gilbert's syndrome, gallstones without symptoms, cancer spread to the liver, or stable long-term liver disease, as judged by your doctor.
  • Have a history of, or current, serious brain or nerve problems, such as seizures, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis. Leukemia in the brain or spinal cord does not rule you out.
  • Have a current disease where the immune system attacks the body, or a history of such a disease that could affect the brain or spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX