Study on Adding Pomalidomide to Standard Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia with Myelodysplastic Syndrome-Related Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04802161
This clinical trial is exploring whether adding the drug pomalidomide to the usual chemotherapy treatment can improve outcomes for patients newly diagnosed with acute myeloid leukemia (AML) that has developed from myelodysplastic syndrome or related conditions.
Patient Parameters
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Program Overview
The purpose of this study is to see if adding pomalidomide to the standard chemotherapy drugs daunorubicin and cytarabine liposome can help treat patients with newly diagnosed acute myeloid leukemia (AML) that has developed from myelodysplastic syndrome or similar conditions. Pomalidomide may help stop cancer growth by affecting blood vessels, boosting the immune system, and killing cancer cells. The study aims to find out if this combination can improve treatment results compared to chemotherapy alone.
Description
This study is divided into two groups to compare treatments:
Group A:
- Patients receive chemotherapy drugs daunorubicin and cytarabine liposome through an IV on specific days, followed by pomalidomide taken by mouth for 14 days.
- If the cancer does not respond, patients may receive another round of chemotherapy.
- Patients who respond well will continue with more chemotherapy cycles and regular tests to monitor progress.
Group B:
- Patients receive the same chemotherapy drugs through an IV on specific days without pomalidomide.
- If the cancer does not respond, patients may receive another round of chemotherapy.
- Patients who respond well will continue with more chemotherapy cycles and regular tests to monitor progress.
After completing the study treatment, patients will be followed up for 30 days and then up to 5 years to monitor their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with acute myeloid leukemia (AML) with at least 20% cancer cells in the bone marrow.
- Must have AML that developed from previous blood disorders or treatments, or has specific genetic changes.
- No prior treatment for AML except for certain medications to reduce white blood cells.
- Aged 18 to 75 years and planned for intensive chemotherapy.
- Good overall health with a performance status score of 0 to 2.
- Normal liver and kidney function based on specific blood tests.
- Heart function must be sufficient, with a pumping ability of at least 50%.
- HIV-positive patients can participate if their viral load is undetectable.
- Hepatitis B or C patients can participate if their viral load is undetectable.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Ability to understand and agree to the study requirements.
Exclusion Criteria
- Certain genetic disorders related to copper metabolism.
- Very high white blood cell counts unless reduced before treatment.
- Previous high exposure to daunorubicin or radiation therapy.
- Active leukemia in the central nervous system.
- Uncontrolled illnesses like infections or heart problems.
- Other active cancers requiring treatment.
- Previous stem cell transplant.
- Recent treatment for related blood disorders.
- Allergies to study drugs or similar medications.
- Pregnant or breastfeeding women.
- Any condition that increases risk during treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| University of Kansas Cancer Center | 66160 | Kansas City | Kansas |
| University of Kansas Hospital-Westwood Cancer Center | 66205 | Westwood | Kansas |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| NYP/Weill Cornell Medical Center | 10065 | New York | New York |
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| Wake Forest University Health Sciences | 27157 | Winston-Salem | North Carolina |
| University of Cincinnati Cancer Center-UC Medical Center | 45219 | Cincinnati | Ohio |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| University of Cincinnati Cancer Center-West Chester | 45069 | West Chester | Ohio |
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