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NCT02527447 · ClinicalTrials.gov registry record
Biomarkers for Personalized Early Assessment of Response During Salvage Chemotherapy in People With Relapsed or Refractory Acute Myeloid Leukemia (PEARL15)
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 15
- Enrollment target
NCT02527447: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02527447 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02527447 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary outcome of this protocol are the outcomes of the blood test performed on day 4 during chemotherapy, and the standard response criteria at day 30 including morphological bone marrow examination following chemotherapy.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-08-18 |
| Est. Completion | 2018-05-10 |
What the finished NCT02527447 record still lists
NCT02527447 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02527447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02527447 about?
NCT02527447 is a clinical study titled "Biomarkers for Personalized Early Assessment of Response During Salvage Chemotherapy in People With Relapsed or Refractory Acute Myeloid Leukemia (PEARL15)". 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 t...
What is the current status of trial NCT02527447?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2015-08-18. Estimated completion is 2018-05-10.
Who is sponsoring clinical trial NCT02527447?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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