Study on Blinatumomab and Chemotherapy or Dasatinib, Prednisone, and Blinatumomab for Treating Older Adults with Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02143414
This clinical trial is exploring how well the drug blinatumomab, combined with chemotherapy or dasatinib and prednisone, works in treating older adults with acute lymphoblastic leukemia (ALL). The study aims to see if these treatments can help the immune system fight cancer and stop cancer cells from growing and spreading.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is testing the effectiveness and safety of using blinatumomab, a type of immunotherapy, along with chemotherapy drugs or a combination of dasatinib and prednisone, in older adults with acute lymphoblastic leukemia (ALL). The goal is to see if these treatments can help the body's immune system attack cancer cells and prevent them from growing and spreading. The study will also look at how well patients respond to these treatments and how long they remain cancer-free.
Description
The study is divided into two groups based on the presence of a specific chromosome, called the Philadelphia chromosome, in the cancer cells.
Group 1 (Philadelphia Chromosome Negative Patients):
- Induction Phase: Patients receive blinatumomab through an IV for 28 days. They will have various tests, including scans and blood tests, to monitor their health.
- Re-Induction Phase: If the cancer does not respond, patients receive another 28-day cycle of blinatumomab.
- Post-Remission Phase: Patients continue with blinatumomab for three more cycles if the cancer is under control.
- Maintenance Phase: Patients take prednisone, vincristine, mercaptopurine, and methotrexate for 18 cycles to maintain remission.
Group 2 (Philadelphia Chromosome Positive Patients):
- Induction Phase: Patients take dasatinib and prednisone for 84 days, with regular health checks.
- Re-Induction Phase: Patients receive blinatumomab for two cycles if needed.
- Post-Remission Phase: Patients continue with blinatumomab and dasatinib for three cycles.
- Maintenance Phase: Patients take dasatinib and prednisone for 18 cycles to maintain remission.
After completing the treatment, patients will have follow-up visits every few months to monitor their health and ensure the cancer does not return.
Eligibility Criteria
Inclusion Criteria
- Must have a new diagnosis of acute lymphoblastic leukemia (ALL) that is not T-cell type.
- Must be 65 years or older.
- Must not have received prior treatment for ALL, except for certain low-dose therapies.
- Must have adequate organ function and no uncontrolled infections.
- Must not have severe nerve damage or autoimmune diseases.
- Must not have other active cancers, except for certain skin or cervical cancers.
- Must agree to provide blood and tissue samples for research.
- Must be able to understand and sign a consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| John L McClellan Memorial Veterans Hospital | 72205 | Little Rock | Arkansas |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
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