Trial · NCT06986174
A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
NCT06986174, Phase 2, Recruiting, Shayna Sarosiek, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia. Trials, record NCT06986174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06986174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
- NCT number
- NCT06986174
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Shayna Sarosiek, MD
- Conditions
- Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, B-Cell Lymphoproliferative Disorder, Indolent Lymphoma
- Interventions
- Pacritinib
- First posted
- 2025-05-22
- Last updated
- 2025-12-05
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 48 months | ORR was defined as the percentage of participants achieving complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR) on treatment based on IWWM-11 criteria. |
| Secondary | Complete Response Rate | Up to 48 months | Complete response rate was defined as the percentage of participants achieving complete response (CR) on treatment based on IWWM-11 criteria, defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A complete response requires reconfirmation demonstrating normal serum IgM levels, and absence of IgM paraprotein by immunofixation by a measurement repeated at least 2 weeks later. |
| Secondary | Very Good Partial Response Rate | Up to 48 months | Very good partial response rate was defined as the percentage of participants achieving very good partial response (VGPR) on treatment based on IWWM-11 criteria, defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels with persistent IgM monoclonal spike in SPEP or immunofixation. |
| Secondary | Partial Response Rate | Up to 48 months | Partial response rate was defined as the percentage of participants achieving partial response (PR) on treatment based on IWWM-11 criteria, Partial response (PR) is defined as achieving a ≥50% to \<90% reduction in serum IgM levels. |
| Secondary | Minimal Response Rate | Up to 48 months | Minimal response rate was defined as the percentage of participants achieving minimal response (MR) on treatment based on IWWM-11 criteria, defined as ≥25 to \<50% reduction in serum IgM levels. |
| Secondary | Stable Disease Rate | Up to 48 months | Stable disease rate was defined as the percentage of participants achieving stable disease (SD) on treatment based on IWWM-11 criteria, defined as \<25% reduction to \<25% increase in serum IgM levels. |
| Secondary | Progressive Disease Rate | Up to 48 months | Stable disease rate was defined as the percentage of participants achieving progressive disease (SD) on treatment based on IWWM-11 criteria, defined as defined as a≥25% increase in serum IgM level occurring with an absolute increase of at least 500 mg/dL from nadir or progression of clinically significant disease-related symptom(s). Reconfirmation of the initial IgM increase is required when IgM is the sole criterion for progressive disease confirmation. Death from any cause or initiation of a new anti-neoplastic therapy will also be considered a progression event. Additionally, a new lesion (\>1.5 cm in any axis) or unequivocal evidence of an increase by \>50% in any axis to \>1.5 cm in size of previously involved extramedullary disease sites from their nadir measurement. Development of Bing Neel syndrome, amyloidosis, or other extramedullary disease manifestations, as well as disease transformation will be considered as progressive events. |
| Secondary | Time to Response (TTR) | Up to 48 months | TTR is the time from treatment initiation until the attainment of a minor response. |
| Secondary | Time to Major Response (TTMR) | Up to 48 months | TTMR is the time from treatment initiation until attaining a PR or better. |
| Secondary | Median Progression-free Survival (PFS) | Up to 48 months | PFS based on Kaplan-Meier methodology is defined as the time from treatment initiation until disease progression, death from any cause, or last follow-up visit. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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/NCT06986174
GET https://conductscience.org/api/trials/v1/NCT06986174/registered?page=2