Solid Tumor CancerPhase 1/2NCT07743086
Impact of Duffy-null Associated Neutropenia on Chemotherapy Dosing
A Phase 1/2 study of Solid Tumor Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 886 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 30 Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Karmanos Cancer Institute
Detroit, Michigan, 48201
Vijendra Singh, M.D., 3135768381, singhv@karmanos.org
About this study
Official title: A Prospective Study of Duffy-null Associated Absolute Neutropenia and Its Impact on Chemotherapy Dosing
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
- Being tested
- Standard of Care chemotherapy Following an Algorithm, Standard of Care chemotherapy following CTCAE criteria
- Keywords
- Duffy-null
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care chemotherapy Following an AlgorithmDrug
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 criteriaDrug
Standard of care chemotherapy for solid tumor malignancies with dose modifications and delays according to the standard of care using CTCAE criteria.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard of Care chemotherapy following CTCAE criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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
Data will be collected at baseline and up until 4 months after the start of chemotherapy, as well as an additional one month in order to assess treatment-related neutropenia and risks associated with therapy. Incidence of neutropenic fever, infection, hospitalization, and treatment-related mortality within the first five months of chemotherapy will be summarized descriptively within each group. Incidence proportions and corresponding two-sided 95% confidence intervals will be reported. Longitudinal patterns of neutrophil counts will be compared between the Duffy-null and non-Duffy-null groups using appropriate longitudinal methods such as mixed-effects models. In addition, exploratory time-to-first-event analyses for neutropenic fever, infection, hospitalization, and treatment-related mortality may be conducted using Cox proportional hazards models adjusted for relevant confounders (e.g., age, cancer type), and will be considered supportive of the descriptive incidence summaries.
Measured: 5 months after the start of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 886 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijendra Singh, Barbara Ann Karmanos Cancer Institute
- Investigators
- Vijendra Singh, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743086
- Sponsor's protocol ID
- 2026-036
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Duffy-null Associated Absolute Neutropenia and Its Impact on Chemotherapy Dosing
- ClinicalTrials.gov ID
- NCT07743086
- Acronym / sponsor ID
- 2026-036
- Conditions
- Solid Tumor Cancer
- Keywords
- Duffy-null
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 886 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duffy-null phenotype positive | Experimental | Drug: Standard of Care chemotherapy Following an AlgorithmIn 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. |
| Non-Duffy-null | Active comparator | Drug: Standard of Care chemotherapy following CTCAE criteriaIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- Participants with active and uncontrolled bacterial, viral, or fungal infection requiring IV antibiotics.
- Participants who have ever received cytotoxic chemotherapy.
- Participants who are receiving concurrent chemo-radiation treatment.
- Participants who are taking any other investigational drugs.
- Participants who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care chemotherapy Following an AlgorithmStandard of care chemotherapy for solid tumor malignancies with dose adjustment according to the algorithm produced in phase 1 for Duffy-null positive patients | Drug | Duffy-null phenotype positive |
| Standard of Care chemotherapy following CTCAE criteriaStandard of care chemotherapy for solid tumor malignancies with dose modifications and delays according to the standard of care using CTCAE criteria. | Drug | Non-Duffy-null |
Primary outcome
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 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.
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
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%.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vijendra Singh, M.D. principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Solid Tumor Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vijendra Singh, M.D. (313-576-8381, singhv@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.