Impact of Duffy-null Associated Neutropenia on Chemotherapy Dosing

NCT07743086 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2026-036
• Study Type: interventional
• Target: 886
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor Cancer

Keywords

Duffy-null

Outcome Measures

Primary Outcomes (2)

• The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85%

  The proportion of patients with chemotherapy RDI (relative dose intensity) \<85% will be estimated separately for the Duffy-null and non-Duffy-null groups. The primary measure of interest is the absolute between-group difference in proportions. A one-sided 90% confidence interval (equivalently, a two-sided 80% confidence interval) will be constructed for this difference. Results will be interpreted relative to the prespecified clinically meaningful threshold of 15% to inform the go/no-go decision for Phase 2. Formal hypothesis testing will be conducted using a one-sided significance level of 10% based on Fisher's exact test.

  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.

  The absolute difference in the proportion of patients with chemotherapy RDI \<85% between the Duffy-null group treated under the purposed dosing algorithm and the non-Duffy-null group treated under standard of care will be estimated. A non-inferiority analysis will be performed using a prespecified margin of 7.5%. A two-sided 80% confidence interval (equivalently, a one-sided 90% confidence interval) will be constructed, and non-inferiority will be concluded if the upper bound of the confidence interval is less than 7.5%.

  5 months after the start of chemotherapy

Secondary Outcomes (1)

• Incidence rates of fever, infection, hospitalization, and treatment-related mortality in the first five months of chemotherapy treatment

  5 months after the start of chemotherapy

Other Outcomes (1)

• Proportion of chemotherapy dose delays or dose reductions attributed to neutropenia, as reported in the physician survey

  5 months after the start of chemotherapy

Study Arms (2)

Duffy-null phenotype positive

EXPERIMENTAL

In phase 2, Patients with a positive Duffy-null blood test plus standard of care chemotherapy with dose adjustment according to an algorithm created in phase 1 of this study.

Drug: Standard of Care chemotherapy Following an Algorithm

Non-Duffy-null

ACTIVE COMPARATOR

In phase 2, patients with a negative Duffy-null blood test plus standard of care chemotherapy. Delays/modifications based on standard CTCAE (Common Terminology Criteria for Adverse Events) grading.

Drug: Standard of Care chemotherapy following CTCAE criteria

Interventions

Standard of Care chemotherapy Following an Algorithm DRUG

Standard of care chemotherapy for solid tumor malignancies with dose adjustment according to the algorithm produced in phase 1 for Duffy-null positive patients

Duffy-null phenotype positive

Standard of Care chemotherapy following CTCAE criteria DRUG

Standard of care chemotherapy for solid tumor malignancies with dose modifications and delays according to the standard of care using CTCAE criteria.

Non-Duffy-null

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Study Officials

• Vijendra Singh, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vijendra Singh, M.D.

CONTACT

313-576-8381; singhv@karmanos.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

US (1)