Trial · NCT07548983
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation
NCT07548983, Phase 1, Recruiting, OHSU Knight Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation. Trials, record NCT07548983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07548983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation
- NCT number
- NCT07548983
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 40 participants, estimated
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Acute Myeloid Leukemia
- Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cyclophosphamide, Echocardiography Test, Electronic Health Record Review, Multigated Acquisition Scan, Mycophenolate Mofetil, Reduced-Intensity Transplant Conditioning Procedure, Ruxolitinib, Survey Administration, Tacrolimus
- First posted
- 2026-04-23
- Last updated
- 2026-10-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) | From cycle 1 day 1 (i.e., day +5 post-transplant) to end of cycle 2 (Cycle length = 28 days) | Will determine the safety and tolerability of ruxolitinib monotherapy (part A) and ruxolitinib plus azacitidine therapy (part B). DLTs will be used to identify a maximum tolerated dose. Dose levels will either be de-escalated, escalated, or retained-according to pre calculated Bayesian Optimal Interval decision rules. |
| Primary | Incidence of grade 3+ treatment-related adverse events (TRAEs) (Part B) | Up to 30 days after the end of cycle 9 | TRAEs of grade 3 and higher experienced during treatment with the doublet of ruxolitinib + azacitidine will be reported (with frequencies and percentages) as a co-primary endpoint. TRAEs are defined as adverse events that are definitely or possibly attributable to study treatment. Will be assessed using Common Terminology Criteria for Adverse Events version 5.0, where adverse events are assessed on a scale of 1-5, with higher scores indicating worse outcomes. |
| Secondary | Graft versus host disease (GVHD)-free, relapse-free survival | From date of transplant to disease relapse, grade III-IV acute (a) GVHD, chronic (c) GVHD requiring systemic immunosuppressive therapy, or death from any cause or last known alive (censored), whichever occurs earlier, assessed up to 2 years | Will be estimated by the Kaplan-Meier method, with estimates provided for the median time-to-event (with 95% log-log confidence interval \[CI\]) and event rates (and 95% log-log CIs) at landmark times like 3-, 6-, 12-, and 24-months post-allogeneic hematopoietic stem cell transplant (HSCT). |
| Secondary | Overall survival | From date of transplant to last known alive (censored) or death date, assessed up to 2 years | Will be estimated by the Kaplan-Meier method, with estimates provided for the median time-to-event (with 95% log-log CI) and event rates (and 95% log-log CIs) at landmark times like 3-, 6-, 12-, and 24-months post-allogeneic HSCT. |
| Secondary | Cumulative incidence of neutrophil engraftment | From date of transplant to 30 days post-HSCT | Deaths in the absence of the event of interest will be considered as a competing risk. Cumulative incidence function (CIF) estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of platelet engraftment | From date of transplant to 100 days post-HSCT but prior to Part B | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of Blood and Marrow Transplant Clinical Trials Network grade 2-3 infections | From date of transplant to 100 days post-HSCT | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of grade ≥ II aGVHD | From date of transplant to end of study, assessed up to 2 years | Will be assessed using Mount Sinai Acute Graft Versus Host Disease International Consortium criteria. Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of cGVHD requiring systemic immunosuppressive therapy | From day +100 post-HSCT to end of study, assessed up to 2 years | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of relapse | From date of transplant to end of study, assessed up to 2 years | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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/NCT07548983
GET https://conductscience.org/api/trials/v1/NCT07548983/registered