NCT04727827: IMPPACT

Pharmacogenomic-Guided Supportive Care in Hematopoietic Cell Transplantation

Completed NA Last updated 3 August 2023

What this trial tests

NA trial testing Pharmacogenomic-guided supportive care in Hematopoietic Cell Transplantation in 110 participants. Completed in 9 June 2023.

Timeline

1 February 2021

Primary endpoint
9 June 2023

9 June 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	110
Start date	1 February 2021
Primary completion	9 June 2023
Estimated completion	9 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Pharmacogenomic-guided supportive care

Conditions studied

• Hematopoietic Cell Transplantation — all drugs for Hematopoietic Cell Transplantation →
• Oncology — all drugs for Oncology →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Hematopoietic Cell Transplantation or Oncology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hematopoietic cell transplantation (HCT) is the only curative treatment modality for many hematologic malignancies. Morbidity and mortality rates have declined drastically over the years, secondary to improvements in both transplant techniques and pharmacotherapies, including immunosuppressants, anti-infectives, analgesics and other supportive care medications. Despite advances in patient care, toxicities associated with HCT (e.g., graft-versus-host disease (GVHD), infection, pain, anxiety, depression, mucositis, nausea/vomiting) continue to pose challenges in patient care and have a significant impact on quality of life. (QOL). A recent study demonstrated subjects randomized to intensive supportive care had a clinically significant improvement in their QOL during hospitalization and up to 3 months post-transplant compared to those receiving standard care.

Further follow up evaluations have evaluated the impact of focused palliative care/symptom management on QOL metrics - inclusive of Edmonton Symptom Assessment surveys (ESAS). In other malignant settings, i.e. solid tumor, ESAS has been noted as an effective measure of symptoms control and the utilization of this assessment is linked to positive outcomes. The American Society of Clinical Oncology (ASCO) has designated QOL as the second most relevant metric for post-transplant patient care behind survival, making the optimization of supportive care pharmacotherapy a clinically relevant subject to investigate. Pharmacogenetics (PGx) uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose selection. SNPs encode drug-metabolizing enzymes, transporters, and targets that can significantly impact drug efficacy and toxicity. With the growing complexity of both antineoplastics and supportive care, oncologists have less time to manage each subject's myriad of supportive care concerns by trial and error. Suboptimal management of symptoms compromises potential benefits from cancer therapy, disrupts clinic workflow, increases emergency room visits, and affects both patient satisfaction and reimbursement. Genetic variation is well documented across the human genome and affects a subject's response to medications regarding efficacy and toxicity. The genome is quickly becoming a pragmatic tool that can assist oncologists and other providers in optimizing supportive care for subjects with cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.