Recruiting
Phase 2

Blinatumomab, Inotuzumab Ozogamicin, Combination Chemotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02877303

Conditions

B Acute Lymphoblastic Leukemia

B Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Blinatumomab

Cyclophosphamide

Cytarabine

Dexamethasone

Doxorubicin Hydrochloride

Study Details

Brief summary:

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.

Conditions

B Acute Lymphoblastic Leukemia

B Lymphoblastic Lymphoma

Study ID

NCT02877303

Start date

Nov 1, 2016

Status verified date

May, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (blinatumomab, inotuzumab, combination chemotherapy)

See detailed description.

Interventions

Blinatumomab

Given IV

Cyclophosphamide

Given IV

Cytarabine

Given IT and IV

Dexamethasone

Given PO

Doxorubicin Hydrochloride

Given IV

Inotuzumab Ozogamicin

Given IV

Laboratory Biomarker Analysis

Correlative studies

Mercaptopurine

Given PO

Methotrexate

Given IT, IV, and PO

Ofatumumab

Given IV

Prednisone

Given PO

Rituximab

Given IV

Vincristine Sulfate

Given IV

Primary outcome measure

  • Relapse-free survival (RFS) [ Time Frame: From date of treatment start until the date of death or disease relapse, assessed for up to 24 months ]

Central Contacts and Locations

Central contacts

Elias Jabbour

713-792-4764ejabbour@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Elias Jabbour

713-792-4764ejabbour@mdanderson.org

Principal Investigator:

Elias Jabbour

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20.