Summary

Eligibility
for people ages 30-70 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. 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. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

Official Title

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Details

Keywords

Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Philadelphia Chromosome, Dietary Calcium, Leucovorin, Folic Acid, Cytarabine, Dexamethasone, Dexamethasone acetate, Prednisone, Cortisone, Cyclophosphamide, Rituximab, Methotrexate, Etoposide, Vincristine, Etoposide phosphate, Daunorubicin, Asparaginase, Mercaptopurine, Podophyllotoxin, Pegaspargase, Blinatumomab, Immunological Antineoplastic Agents, Muromonab-CD3, Antibodies, Immunoglobulins, Monoclonal Antibodies, Bispecific Antibodies, BB 1101, Calcium, Levoleucovorin, Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Daunorubicin Hydrochloride, Leucovorin Calcium, Lumbar Puncture, Vincristine Sulfate, X-Ray Imaging, blinatumomab, chemotherapy, chemotherapy

Eligibility

Locations

  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank California 91505 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT02003222
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 488 people participating
Last Updated