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Biomarkers for Personalized Early Assessment of Response During Salvage Chemotherapy in People With Relapsed or Refractory Acute Myeloid Leukemia (PEARL15)

NCT02527447 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2019-10-30

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Christopher S Hourigan, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-18
Primary Completion
2018-05-10
Completion
2018-05-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527447 on ClinicalTrials.gov