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

NCT02527447 | Completed

• 2 other identifiers: 15017615-H-0176
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Acute Myeloid Leukemia

Keywords

Measurable Residual Disease; Relapsed/Refractory AML; Salvage Chemotherapy

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this protocol are the outcomes of the blood test performed on day 4 during chemotherapy, and the standardresponse criteria including morphological bone marrow examination following chemotherapy.

  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.

  4 days

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unequivocal diagnosis of relapsed or refractory acute myeloid leukemia (AML) according to WHO criteria confirmed by bone marrow evaluation within 30 days prior to study enrollment
• Age 18-70 years inclusive
• ECOG performance status of 0 to 2
• Must have received at least one prior AML therapy before study enrollment
• Ability to comprehend the investigational nature of the study and provide informed consent
• Availability of a physician willing to assume clinical care after completion of this research study.
• Subject agreement to use a medically-approved method of contraception to avoid pregnancy throughout the study if a woman of childbearing potential or a male subject with partner of childbearing potential.

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)

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher S Hourigan, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 19, 2015
• Study Start: August 18, 2015
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: October 30, 2019

Record last verified: 2019-10-28

Locations

US (1)