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Not yet recruiting NCT07743086

Impact of Duffy-null Associated Neutropenia on Chemotherapy Dosing

Phase I / Phase II Interventional Solid Tumor Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care chemotherapy Following an Algorithm, Standard of Care chemotherapy following CTCAE criteria.
Who it may be relevant to
Registry conditions: Solid Tumor Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Study of Duffy-null Associated Absolute Neutropenia and Its Impact on Chemotherapy Dosing

Overview

The goal of this clinical trial is to: * In Phase 1 (observational) to develop an algorithm for treatment of Duffy-null positive patients for chemotherapy dosing * In Phase 2 (interventional), use the algorithm created in phase 1 to adjust chemotherapy dosing for Duffy-null patients

Interventions

  • Drug Standard of Care chemotherapy Following an Algorithm
    Standard of care chemotherapy for solid tumor malignancies with dose adjustment according to the algorithm produced in phase 1 for Duffy-null positive patients
  • Drug Standard of Care chemotherapy following CTCAE criteria
    Standard of care chemotherapy for solid tumor malignancies with dose modifications and delays according to the standard of care using CTCAE criteria.

Primary outcome measures

  • The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85% [Time frame: 5 months after the start of chemotherapy]
  • The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI (relative dose intensity) <85% after implementation of a new purposed algorithm from Phase 1. [Time frame: 5 months after the start of chemotherapy]
Secondary outcome measures (1)
  • Incidence rates of fever, infection, hospitalization, and treatment-related mortality in the first five months of chemotherapy treatment [Time frame: 5 months after the start of chemotherapy]

Eligibility criteria

Inclusion criteria

  • Participant must self-identify as being of Middle Eastern or African descent.
  • Participant must be diagnosed with histologically or cytologically confirmed solid organ cancer and be treatment naive.
  • Melanoma is allowed; sarcoma is not eligible.
  • Secondary malignancies are allowed.
  • Participants who have received only surgery alone as treatment are eligible
  • Participant must be between the ages of 18-80.
  • Participant or their legally authorized representative (LAR) must be able to understand a written informed consent document and be willing to sign it.

Exclusion criteria

  • Participants with active and uncontrolled bacterial, viral, or fungal infection requiring IV antibiotics.
  • Participants may be eligible for the study if the infection is deemed to be under control per investigator's discretion.
  • Participants who have ever received cytotoxic chemotherapy.
  • Those who have already started a chemotherapy regimen with moderate likelihood of developing neutropenia will be considered for enrollment at the principal investigator's discretion.
  • Participants who are receiving concurrent chemo-radiation treatment.
  • Participants who are taking any other investigational drugs.
  • Participants who are pregnant or breastfeeding.
  • Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Karmanos Cancer Institute — Detroit

Identifiers

NCT: NCT07743086 · 2026-036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗