Study on Using Nivolumab to Prevent Acute Myeloid Leukemia from Returning After Treatment
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02275533
This clinical trial is testing whether the drug nivolumab can help eliminate remaining cancer cells and prevent acute myeloid leukemia (AML) from coming back in patients who have shown improvement after chemotherapy.
Patient Parameters
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Program Overview
This phase II study is exploring how well nivolumab, an immunotherapy drug, works in getting rid of any leftover cancer cells and stopping the return of acute myeloid leukemia (AML) in patients who have responded to chemotherapy. Nivolumab is a type of treatment that helps the immune system attack cancer cells and may prevent them from growing and spreading.
Description
The main goal of this study is to see if patients who receive nivolumab have a longer period without the cancer coming back compared to those who are just observed. Researchers will also look at overall survival rates and any side effects of nivolumab.
Patients will be divided into two groups:
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Group 1: Patients will receive nivolumab through an IV every two weeks for up to 46 cycles, as long as the cancer does not progress and side effects are manageable. They will have regular bone marrow biopsies and blood tests to monitor their condition.
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Group 2: Patients will be monitored with standard care for up to two years. If the cancer returns, they may switch to the nivolumab group. They will also have regular bone marrow biopsies and blood tests.
After the treatment phase, all patients will be followed up regularly for two years, then every six months for a year, and annually after that.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older with acute myeloid leukemia (AML) in first complete remission after chemotherapy.
- Patients who are not candidates for stem cell transplant due to age, health conditions, or personal choice.
- Good overall health with a performance status of 0 or 1.
- Life expectancy of more than six months.
- Adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential and men must agree to use effective contraception during the study and for a specified period after the last dose of nivolumab.
- Ability to understand and sign a written informed consent document.
Exclusion Criteria
- Recent chemotherapy or radiotherapy within four weeks before starting the study.
- Previous treatment with certain immune-targeting drugs.
- Active central nervous system involvement unless cleared before treatment.
- Severe allergic reactions to similar drugs.
- Uncontrolled illnesses or infections.
- Pregnant or breastfeeding women.
- Positive tests for HIV or hepatitis unless under control.
- Active autoimmune diseases requiring treatment.
- Use of systemic steroids or immunosuppressive medications within 14 days before starting the study, except for certain low-dose or specific types.
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 |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
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