Pharmacogenomic-Guided Supportive Care in Hematopoietic Cell Transplantation

NCT04727827 | Completed DMC

• 1 other identifier: LCI-HEM-BMT-IMPPACT-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic Cell Transplantation; Oncology

Keywords

pharmacogenomic; precision medicine; pharmacy practice; bone marrow transplantation

Outcome Measures

Primary Outcomes (1)

• Frequency of subjects undergoing PGx testing who receive at least one drug/dose selection or modification.

  The primary objective is to estimate the frequency of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on their test results during the study period

  from admission for HCT to HCT Day +100

Secondary Outcomes (6)

• Improvements in symptoms from PGx-guided supportive care

  HCT admission

• Improvements in symptoms from PGx-guided supportive care

  HCT Day +30

• Longitudinal symptoms measurements with PGx-guided supportive care

  From baseline to Day +30, Day +60 and Day +100 in those who enroll to the study

• Determine the type and frequency of actionable genetic polymorphisms observed in the evaluable population and in the subset that received a drug and/or dose selection/modification

  From baseline to Day +30 in those who enroll to the study

• Determine the type and frequency of actionable genetic polymorphisms observed in the evaluable population and in the subset that received a drug and/or dose selection/modification

  From baseline to Day +60 in those who enroll to the study

Study Arms (1)

Pharmacogenomic Testing

EXPERIMENTAL

A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response.

Other: Pharmacogenomic-guided supportive care

Interventions

Pharmacogenomic-guided supportive care OTHER

Patients undergoing hematopoietic stem cell transplantation will be genotyped and supportive care therapies tailored to identified drug-gene pairs and guideline recommendations

Pharmacogenomic Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information
• Age ≥ 18 years at the time of consent
• Scheduled HCT (allogeneic and autologous, any conditioning regimen) treatment for any malignant or non-malignant indications (i.e. aplastic anemia)
• Ability to read and understand English or Spanish
• Able to provide a buccal sample for DNA extraction and genotyping

You may not qualify if:

• Psychiatric illness/social situations, or active/recent (within 30 days) history of elicit substance abuse that would limit compliance with study requirements as determined by the investigator

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Justin R Arnall, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective, pre/post interventional, single arm study

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Locations

US (1)