Impact of Duffy-null Associated Neutropenia on Chemotherapy Dosing

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07743086
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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

Key Dates

First listed
Aug 3, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
886 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Duffy-null phenotype positive
    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.
  • Active Comparator: Non-Duffy-null
    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.

Primary Outcome Measure

The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85% [ Time Frame: 5 months after the start of chemotherapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Vijendra Singh, M.D.
[email protected]
3135768381

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By research site
Karmanos Cancer Institute· Detroit, MI

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