Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03488225
Phase
PHASE2
Status
Terminated

Conditions

  • Acute Lymphoblastic Leukemia in Remission
  • B Acute Lymphoblastic Leukemia
  • B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT or IV
  • Dexamethasone — DRUG
    Given IV or PO
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Inotuzumab Ozogamicin — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Leucovorin Calcium — DRUG
    Given IV
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT, IV or 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 combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.

Key Dates

Start date
Mar 28, 2018
Status verified
Jul 2024
Primary completion
Apr 2, 2020
Completion
Apr 2, 2020

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (hyper-CVAD, inotuzumab ozogamicin)
    See detailed description.

Primary Outcome Measure

Event-Free Survival [ Time Frame: Start of treatment up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

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

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