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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02877303
Phase
PHASE2
Status
Recruiting
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Conditions

  • B Acute Lymphoblastic Leukemia
  • B Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — BIOLOGICAL
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT and IV
  • Dexamethasone — DRUG
    Given PO
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Inotuzumab Ozogamicin — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT, IV, and PO
  • Ofatumumab — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 1, 2016
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (blinatumomab, inotuzumab, combination chemotherapy)
    See detailed description.

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

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Elias Jabbour
[email protected]
713-792-4764
Elias Jabbour (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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