Trial · NCT06986174
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Secondary | Time to Next Treatment (TTNT) | Up to 48 months | TTNT is the time between treatment initiation and initiation of the next therapy. |
| Secondary | Median Overall Survival (OS) | Up to 6 years | OS is defined as the time from treatment initiation until death from any cause or last follow-up visit |
| Secondary | Bone marrow response | Up to 48 months | Absolute change in bone marrow burden of disease from baseline |
| Secondary | Overall Response Rate Among Participants Without MYD88 Mutations | Up to 48 months | Overall Response Rate in participants who tested negative for a MYD88 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly). |
| Secondary | Overall Response Rate Among Participants With MYD88 Mutations | Up to 48 months | Overall Response Rate in participants who tested positive for a MYD88 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly). |
| Secondary | Overall Response Rate Among Participants Without CXCR4 Mutations | Up to 48 months | Overall Response Rate in participants who tested negative for a CXCR4 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly). |
| Secondary | Overall Response Rate Among Participants With CXCR4 Mutations | Up to 48 months | Overall Response Rate in participants who tested positive for a CXCR4 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly). |
| Secondary | Overall Response Rate Among Participants With TP53 Mutations | Up to 48 months | Overall Response Rate in participants who tested positive for a TP53 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly). |
| Secondary | Overall Response Rate Among Participants Without TP53 Mutations | Up to 48 months | Overall Response Rate in participants who tested negative for a TP53 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly). |
| Secondary | Number of Participants With Treatment-related Adverse Events | Up to 48 months | Number of participants who experienced an adverse event while on pacritinib |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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