Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03518112
Phase
PHASE2
Status
Terminated

Conditions

  • Philadelphia Chromosome Negative
  • Recurrent B Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Interventions

  • Blinatumomab — BIOLOGICAL
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT or IV
  • Dexamethasone — DRUG
    PO or IV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Leucovorin Calcium — DRUG
    Given IV
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT or IV
  • Pegfilgrastim — BIOLOGICAL
    Given SC
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, 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 blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.

Key Dates

Start date
Apr 18, 2018
Status verified
Nov 2022
Primary completion
May 27, 2021
Completion
May 27, 2021

Study Design

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

Arms

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

Primary Outcome Measure

Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death [ Time Frame: Time from the first day of treatment assessed up to 3 years, 1 month ]

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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