Trial · NCT07341867
Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype
NCT07341867, Phase 1, Recruiting, Andrew Hantel, MD
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype. Trials, record NCT07341867. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07341867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype
- NCT number
- NCT07341867
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 90 participants, estimated
- Lead sponsor
- Andrew Hantel, MD
- Conditions
- Multiple Myeloma, Triple Negative Breast Cancer, Duffy Blood Group, Chemokine Receptor Gene Mutation, Duffy Blood Group, Chemokine Receptor Gene C.-67T>C
- Interventions
- Dexamethasone, Bortezomib, LENALIDOMIDE, Daratumumab, Carboplatin, Paclitaxel, Pembrolizumab, Cyclophosphamide, Doxorubicin
- First posted
- 2026-01-14
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Avoided or reduced systemic anticancer therapy (SACT) modifications per cycle | Avoided or reduced modifications determined by ANC (anticancer therapy) values in each treatment cycle. Coh 1 (Dara-RVD) is 6 cycles(cycle=28 dys)-ANC assessed days 1, 8, 15, & 22. Coh 2 has 8 cycles (cycle=21 dys)-ANC assessed days 1, 8, & 15 | An ANC-related avoided or reduced SACT change is defined as an instance of no change in SACT dosing (by avoiding a dose hold, dose level change, or drug discontinuation) OR an instance of reduction in the SACT dose modification (through earlier resumption of therapy with or without avoidance of a dose modification in a subsequent cycle) using this study's Duffy null-specific parameters for ANC dose modifications compared to the dose modification that would have occurred according to the parameters used in PERSEUS (Dara-RVD) or Keynote 522 trials. For the primary outcome measure, an ANC-related avoided or reduced SACT change is measured on a per-cycle basis as a binary outcome. |
| Primary | Overall cumulative incidence of neutropenic fever | Neutropenic fever is assessed from treatment initiation through the end of protocol-based treatment. It will be assessed at baseline and before treatment dosing during each cycle (Coh1 is 6 cycles (cycle=28 days); Coh 2 is 8 cycles (cycle=21 days)). | Neutropenic fever is defined using modified CTCAE criteria. Grade 3 being defined as "ANC\<500/uL with a single temperature of \>38.3 C or a sustained temperature of \>38 for more than one hour"; and Grade 4 defined as "Life-threatening consequences; urgent intervention indicated". The cumulative incidence will be calculated as the number of participants with at least one documented occurrence of neutropenic fever, over the total number of participants enrolled. |
| Secondary | Avoided or reduced systemic anticancer therapy (SACT) modifications per ANC check (i.e. per week) | Avoided or reduced modifications determined by ANC (anticancer therapy) values during each treatment cycle. Coh1 (Dara-RVD) is 6 cycles(cycle=28 dys)- ANC assessed on days 1, 8, 15, & 22. Coh 2 is 8 cycles (cycle=21 dys)- ANC assessed days 1, 8, & 15 | An ANC-related avoided or reduced SACT change is defined as an instance of no change in SACT dosing (by avoiding a dose hold, dose level change, or drug discontinuation) OR an instance of reduction in the SACT dose modification (through earlier resumption of therapy with or without avoidance of a dose modification in a subsequent cycle) using this study's Duffy null-specific parameters for ANC dose modifications compared to the dose modification that would have occurred according to the parameters used in PERSEUS (Dara-RVD) or Keynote 522 trials. For the secondary outcome measure, an ANC-related avoided or reduced SACT change is measured on a per-ANC check basis as a binary outcome. |
| Secondary | Cumulative incidence of neutropenic fever within regimen | Neutropenic fever will be assessed from initiation of treatment through end of the last cycle of protocol-based treatment; cycle length and number varies by phase of therapy. It will be assessed at baseline and before therapy dosing during each cycle. | Neutropenic fever is defined using modified CTCAE criteria. Grade 3 being defined as ""ANC\<500/uL with a single temperature of \>38.3 C or a sustained temperature of \>38 for more than one hour""; and Grade 4 defined as ""Life-threatening consequences; urgent intervention indicated"". The cumulative incidence will be calculated as the number of participants with at least one documented occurrence of neutropenic fever, over the total number of participants enrolled in the regimen." |
| Secondary | Relative dose intensity (RDI) | Dosing, for the calculation of RDI, will be assessed immediately at the time of protocol-specified treatment from the initiation of treatment through treatment completion, an average of 6 months. Cycle and treatment length vary by treatment phase. | RDI will be calculated as the dose of the therapy administered divided by the dose as specified in the protocol. For multi-agent regimens, dose intensity will be calculated separately for each agent. Calculations will be done within patient. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07341867
GET https://conductscience.org/api/trials/v1/NCT07341867/registered