Using blinatumomab, inotuzumab ozogamicin, and chemotherapy to treat B acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using inotuzumab ozogamicin with chemotherapy for high-risk B-cell leukemia

  This study is testing if adding a targeted therapy called inotuzumab ozogamicin to standard chemotherapy can help young patients with high-risk B-cell leukemia live longer without their cancer coming back.

  Recruiting at 212 sites Phase 3 Children's Oncology Group · Birmingham, Alabama and 230 other locations · NCT03959085

• Lower versus higher hemoglobin thresholds for red blood cell transfusions in adults with high-grade myeloid cancers or B-cell ALL/lymphoma

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  Recruiting University of Washington · Seattle, Washington · NCT06710418

• Combining Blinatumomab and Venetoclax with Inotuzumab Ozogamicin for B-ALL Treatment

  This study is testing a new combination of three medications to see if it can help adults with newly diagnosed B-cell acute lymphoblastic leukemia live longer and healthier lives.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT06554626

• Combining venetoclax and blinatumomab with standard chemotherapy for infants with acute leukemia

  This study is testing whether adding two new treatments, venetoclax and blinatumomab, to standard chemotherapy can help infants with acute leukemia do better and stay cancer-free longer.

  Recruiting at 117 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 116 other locations · NCT06317662

• Using Brexucabtagene Autoleucel to treat B-cell Acute Lymphoblastic Leukemia after initial therapy

  This study is testing a new CAR-T cell therapy called brexucabtagene autoleucel to see if it can help people with B-cell acute lymphoblastic leukemia who haven't responded to other treatments.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT06287229

• Combining blinatumomab with dasatinib or imatinib plus chemotherapy for young people with Ph+ or ABL-class Ph-like B‑ALL

  This pilot will see if adding three cycles of blinatumomab and a continuous tyrosine kinase inhibitor (dasatinib or imatinib) to a modified chemotherapy plan helps children, adolescents, and young adults with Ph+ or ABL-class Ph-like B‑ALL stay in remission longer.

  Recruiting at 159 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 160 other locations · NCT06124157

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.