Trial · NCT07033598
Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
NCT07033598, Phase 2, Recruiting, Theradex
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia. Trials, record NCT07033598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07033598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
- NCT number
- NCT07033598
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 66 participants, estimated
- Lead sponsor
- Theradex
- Conditions
- Leukemia, Myelomonocytic, Chronic
- Interventions
- Pacritinib, Hydroxyurea
- First posted
- 2025-06-24
- Last updated
- 2026-08-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline hemoglobin \<10 g/dL, response is defined as either a ≥1.5 g/dL hemoglobin increase lasting ≥8 weeks without red blood cell transfusion, or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of red blood cell transfusion independence, excluding transfusions given for pretreatment Hb ≤8.5 g/dL. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving platelet response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline platelet counts \<100 × 10⁹/L, response is defined as one of the following: an increase to ≥20 × 10⁹/L and by ≥100% for ≥8 weeks without platelet transfusion (if baseline \<20 × 10⁹/L); an increase of ≥30 × 10⁹/L for ≥8 weeks without transfusion (if baseline 20-\<100 × 10⁹/L); or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of platelet transfusion independence. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving neutrophil response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline ANC ≤1 × 10⁹/L, response is defined as either an increase to \>0.5 × 10⁹/L and by ≥100% for ≥8 weeks without myeloid growth factors (if baseline ANC ≤0.5 × 10⁹/L), or an increase by ≥50% for ≥8 weeks without myeloid growth factors (if baseline ANC \>0.5 to ≤1 × 10⁹/L). Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving spleen response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline spleen ≥5 cm below the left costal margin (midclavicular line), spleen response is defined as a ≥35% reduction in spleen volume at endpoint assessment by MRI or CT. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving symptom response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | Among participants with baseline Total Symptom Score (TSS) ≥20 per the MPN-SAF TSS: achieving ≥50% TSS reduction from baseline at the time of endpoint assessment. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Secondary | Clinical benefit at any time, defined as achieving at least one of the primary endpoint clinical benefit response criteria at any time on study. | Measured from the start of study treatment to the end of treatment, for up to 48 weeks. | |
| Secondary | Achieving response at Week 24 and 48 according to the IWG 2015 criteria), including the following subtypes: complete response, complete cytogenetic remission, partial remission, marrow response | Measured from Week 24 through the end of treatment, up to 48 weeks. | |
| Secondary | Duration of response for primary endpoint (clinical benefit by Week 24) | Measured from Week 24 through the end of treatment, up to 48 weeks. | |
| Secondary | Event-free survival | Measured from the start of study treatment to the end of treatment, for up to 48 weeks. | Event-free survival is defined as the time without death from any cause, transformation to AML (including granulocytic sarcoma), or disease progression after ≥3 cycles (Week 12), including CMML-1 to CMML-2 with ≥5% absolute blast increase or worsening splenomegaly. |
| Secondary | Leukemia-free survival, where events include death from any cause or transformation to AML (including granulocytic sarcoma) | Measured from the start of study treatment to the end of treatment, for up to 48 weeks. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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/NCT07033598
GET https://conductscience.org/api/trials/v1/NCT07033598/registered