NCT02527447

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

Completed Last updated 30 October 2019

What this trial tests

trial in Acute Myeloid Leukemia in 15 participants. Completed in 10 May 2018.

Timeline

18 August 2015

Primary endpoint
10 May 2018

10 May 2018

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15
Start date	18 August 2015
Primary completion	10 May 2018
Estimated completion	10 May 2018
Sites	1 location across United States

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 99, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bone marrow evaluation for diagnosis and monitoring of acute myeloid leukemia.
   Percival ME, Lai C, Estey E, Hourigan CS. · · 2017 · cited 84× · PMID 28190619 · DOI 10.1016/j.blre.2017.01.003
2. Molecular Measurable Residual Disease Testing of Blood During AML Cytotoxic Therapy for Early Prediction of Clinical Response.
   Wong HY, Sung AD, Lindblad KE, Sheela S, et al · · 2018 · cited 16× · PMID 30697529 · DOI 10.3389/fonc.2018.00669
3. Role of Biomarkers in the Management of Acute Myeloid Leukemia.
   Small S, Oh TS, Platanias LC. · · 2022 · cited 11× · PMID 36498870 · DOI 10.3390/ijms232314543
4. The theragnostic advances of exosomes in managing leukaemia.
   Ghosh S, Dey A, Chakrabarti A, Bhuniya T, et al · · 2024 · cited 8× · PMID 39659020 · DOI 10.1111/jcmm.70052
5. Timed sequential salvage chemotherapy for relapsed or refractory acute myeloid leukemia.
   Popescu B, Sheela S, Thompson J, Grasmeder S, et al · · 2020 · cited 6× · PMID 32190831 · DOI 10.2991/chi.d.191128.001
6. Successful salvage chemotherapy and allogeneic transplantation of an acute myeloid leukemia patient with disseminated <i>Fusarium solani</i> infection.
   Sheela S, Ito S, Strich JR, Manion M, et al · · 2017 · cited 5× · PMID 28794968 · DOI 10.1016/j.lrr.2017.07.001