Biomarkers for Personalized Early Assessment of Response During Salvage Chemotherapy in People With Relapsed or Refractory Acute Myeloid Leukemia (PEARL15)
Completed
Conditions studied: Acute Myeloid Leukemia
In brief
Background: -Acute myeloid leukemia (AML) is a cancer of the white blood cells. It can be fatal. Standard treatment involves intensive chemotherapy. Not all treatment works. AML that has not responded to treatment (refractory) or that has returned after treatment (relapsed) is high-risk even with treatment. Success of therapy is normally determined after 28 to 56 days. This study will see if a blood test on day 4 of therapy can help identify earlier those who will not respond. Objectives: -To see if a blood test on day 4 of therapy can help identify those who will not respond to treatment for AML. Eligibility: -People ages 18-70 who have refractory or relapsed AML and have had at least one previous therapy for it. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will have: * Several blood tests. * Bone marrow exams: a needle is inserted into the hip to take cells from the bone marrow. * Echocardiogram: a small probe is held to the chest to take pictures of the heart. * ECG: soft electrodes are stuck to the skin. A machine records the heart s signals. * CT scans: they will lie in a machine that takes pictures of the body. * Standard chemotherapy. * Possible transfusions of blood products such as red blood cells or platelets. * Participants will be expected to stay in the study typically for 2 3 months. This will include inpatient treatment. Inpatient stay normally will be 1 or 2 months.
Key facts
- Study ID
- NCT02527447
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 15
- Starts
- 2015-08-18
- Expected to finish
- 2018-05-10
- Last updated by the study team
- 2019-10-30
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Diagnosis of acute promyelocytic leukemia
- Decreased oxygen saturation at rest (e.g. pulse oximeter less than 88% or PaO2 less than or equal to 55 millimeters of mercury)
- Clinically significant active infection not responding adequately to therapy
- Known positive or history of HIV; active Hepatitis B or C infection. If unknown, screening will be done but results are not needed before proceeding with treatment
- Prior allogeneic hematopoietic stem cell transplant
- Additional malignancy requiring concurrent treatment
- Uncontrolled hepatic, renal, cardiac, gastrointestinal, pulmonary, neurologic, infectious, metabolic or other disease of such severity, which in the opinion of the PI, would preclude ability to tolerate protocol.
- Severe psychiatric illness or complex social situations that would limit the patient s ability to tolerate and/or comply with study requirements.
- Active central nervous system (CNS) leukemic infiltration
- Current pregnancy or breastfeeding
- Prolonged QTc interval prior to therapy (>470ms)
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.