Waldenström MacroglobulinemiaPhase 2NCT06986174
A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
A Phase 2 study testing Pacritinib in people with Waldenström Macroglobulinemia and Lymphoplasmacytic Lymphoma, run by Shayna Sarosiek, MD at 1 site in United States.
Trial summary
This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM). The name of the study drug involved in this study is: -Pacritinib (a type of kinase inhibitor) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, B-Cell Lymphoproliferative Disorder
- What is being tested?
- Pacritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to 1 Oct 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- ECOG performance status ≤2
- Clinicopathological diagnosis of Waldenström Macroglobulinemia
- Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:
- constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss
- progressive or symptomatic lymphadenopathy or splenomegaly
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- hemoglobin ≤10 g/dL
- platelet count ≤100 k/uL
- hyperviscosity syndrome
- symptomatic peripheral neuropathy
- systemic amyloidosis
- renal insufficiency
- symptomatic cryoglobulinemia
- Serum IgM level ≥ 2 times the upper limit of normal
- Participants must meet the following organ and marrow functions as defined below:
- absolute neutrophil count ≥0.5 k/uL without growth factor within 7 days
- platelet count ≥50 k/uL without platelet transfusion within 7 days
- total bilirubin ≤1.5 times the upper limit of normal or ≤3 times the upper limit of normal with documented liver involvement, hemolysis or Gilbert's disease
- AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal or ≤5 times the upper limit of normal with documented liver involvement
- Creatinine clearance ≥30 ml/min using Cockcroft/Gault equation
- Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
- At least 2 prior lines of treatment for Waldenström Macroglobulinemia. Participants must either be BTK inhibitor exposed or not be a candidate for BTK therapy.
- Women of childbearing potential: Females of childbearing potential (FCBP) will be required to use two highly effective forms of contraception simultaneously or will remain abstinent from heterosexual intercourse during the following periods related to this study:
- while participating in the study; and 2) for at least three months (90 days) after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed.
Who cannot join
- Current history of uncontrolled HIV
- Patients with a known history of HIV must have a viral load assessed for eligibility and must be on a stable antiretroviral regimen that can be administered concurrent with pacritinib.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below
- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.
- Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.
- Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)
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- Participants who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 month after last study dose (2 weeks for breastfeeding)
- Current CNS involvement by WM
- Active alcohol or drug abuse
- Concurrent administration of medications that are moderate or strong inhibitors or inducers of CYP3A within 14 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
- Concurrent participation in another therapeutic clinical trial
- History of another malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, or other adequately treated cancer currently in complete remission
- Prior or ongoing clinically significant illness, including active infections requiring antibiotics, of medical condition that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results
- Inability to swallow pills
- Significant cardiovascular disease defined as:
- Unstable angina, or
- History of myocardial infarction within 6 months prior to planned start
- Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during screening should be performed in selected patients as medically indicated, or
- Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
- Uncontrolled or symptomatic arrhythmias
- Prolonged QT Interval with baseline QTc >480 msec using the Bazette formula
- Ongoing, active infection.
- Active bleeding requiring blood transfusion or other medical intervention. Participants requiring anticoagulation therapy are not excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Shayna Sarosiek, MD, 617-632-4218, Shayna_sarosiek@dfci.harvard.edu
Shayna Sarosiek, MD
About this study
This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM).
The name of the study drug involved in this study is:
-Pacritinib (a type of kinase inhibitor)
Read the detailed description
This is a single-arm, open-label, Phase II study to evaluate the safety and efficacy of pacritinib in participants with symptomatic Waldenström macroglobulinemia (WM).
Pacritinib is a targeted therapy that blocks a protein called JAK2 that helps cells live and grow. It also inhibits IRAK1, which is important for the survival of WM cells. By blocking JAK2 \& IRAK1, pacritinib may kill abnormal cells or stop them from growing.
The U.S. Food and Drug Administration (FDA) has not approved pacritinib for WM but it has been approved for Myelofibrosis.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, Computerized Tomography (CT) scans, X-rays, echocardiograms (ECGs), bone marrow biopsies and aspirations
Participants will receive study treatment for up to 4 years and will be followed for 2 years, or until there is start of a new treatment.
It is expected that about 30 people will take part in this research study.
Sobi AG, Inc. is supporting this research study by providing study drug and funding.
- Conditions
- Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, B-Cell Lymphoproliferative Disorder, Indolent Lymphoma
- Being tested
- Pacritinib
- Keywords
- Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, Lymphoma, B-Cell Lymphoproliferative Disorder, Indolent Lymphoma
- Medical subject headings
- Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
Also called SB1518, VONJO, Pacritinib Citrate
Kinase inhibitor, capsule, taken orally per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Pacritinib | Experimental | 30 participants will complete:
* Baseline visit with assessments and ECGs
* Cycles 1 through 2 (28 days per cycle):
--Day 1: Predetermined dose of Pacritinib 2x daily
* Cycle 3, 6, 9, 12, and every 3 cycles for 48 cycles total (28 days per cycle):
--Day 1: Predetermined dose of Pacritinib 2x daily
* Bone marrow biopsies/aspirations at Cycles 6 and 12 and then yearly
* End of Treatment visit with CT scan and bone marrow biopsy/aspiration
* Follow up: every 12 weeks for 2 years Receives: Drug: Pacritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: Up to 48 months
Secondary outcomes (20)
Complete Response Rate
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.
Measured: Up to 48 months
Very Good Partial Response Rate
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.
Measured: Up to 48 months
Partial Response Rate
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.
Measured: Up to 48 months
Minimal Response Rate
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.
Measured: Up to 48 months
Stable Disease Rate
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.
Measured: Up to 48 months
Progressive Disease Rate
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.
Measured: Up to 48 months
Time to Response (TTR)
TTR is the time from treatment initiation until the attainment of a minor response.
Measured: Up to 48 months
Time to Major Response (TTMR)
TTMR is the time from treatment initiation until attaining a PR or better.
Measured: Up to 48 months
Median Progression-free Survival (PFS)
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.
Measured: Up to 48 months
Time to Next Treatment (TTNT)
TTNT is the time between treatment initiation and initiation of the next therapy.
Measured: Up to 48 months
Median Overall Survival (OS)
OS is defined as the time from treatment initiation until death from any cause or last follow-up visit
Measured: Up to 6 years
Bone marrow response
Absolute change in bone marrow burden of disease from baseline
Measured: Up to 48 months
Overall Response Rate Among Participants Without MYD88 Mutations
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).
Measured: Up to 48 months
Overall Response Rate Among Participants With MYD88 Mutations
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).
Measured: Up to 48 months
Overall Response Rate Among Participants Without CXCR4 Mutations
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).
Measured: Up to 48 months
Overall Response Rate Among Participants With CXCR4 Mutations
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).
Measured: Up to 48 months
Overall Response Rate Among Participants With TP53 Mutations
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).
Measured: Up to 48 months
Overall Response Rate Among Participants Without TP53 Mutations
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).
Measured: Up to 48 months
Number of Participants With Treatment-related Adverse Events
Number of participants who experienced an adverse event while on pacritinib
Measured: Up to 48 months
Overall Response Rate Among Participants who progressed on covalent BTK-inhibitors
Overall Response Rate in participants who previously progressed on covalent BTK inhibitors= 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).
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start21 Nov 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström MacroglobulinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shayna Sarosiek, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Sobi, Inc.
- Responsible party
- Sponsor-investigator, Shayna Sarosiek, MD, Dana-Farber Cancer Institute
- Investigators
- Shayna Sarosiek, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986174
- Sponsor's protocol ID
- 24-660
- Status last verified
- Dec 2025
- First submitted
- 15 May 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
- ClinicalTrials.gov ID
- NCT06986174
- Acronym / sponsor ID
- 24-660
- Conditions
- Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, B-Cell Lymphoproliferative Disorder, Indolent Lymphoma
- Keywords
- Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, Lymphoma, B-Cell Lymphoproliferative Disorder, Indolent Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shayna Sarosiek, MDUniversity, hospital or other
- Collaborators
- Sobi, Inc.
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM).
The name of the study drug involved in this study is:
-Pacritinib (a type of kinase inhibitor)
Detailed description
This is a single-arm, open-label, Phase II study to evaluate the safety and efficacy of pacritinib in participants with symptomatic Waldenström macroglobulinemia (WM).
Pacritinib is a targeted therapy that blocks a protein called JAK2 that helps cells live and grow. It also inhibits IRAK1, which is important for the survival of WM cells. By blocking JAK2 \& IRAK1, pacritinib may kill abnormal cells or stop them from growing.
The U.S. Food and Drug Administration (FDA) has not approved pacritinib for WM but it has been approved for Myelofibrosis.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, Computerized Tomography (CT) scans, X-rays, echocardiograms (ECGs), bone marrow biopsies and aspirations
Participants will receive study treatment for up to 4 years and will be followed for 2 years, or until there is start of a new treatment.
It is expected that about 30 people will take part in this research study.
Sobi AG, Inc. is supporting this research study by providing study drug and funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacritinib | Experimental | Drug: Pacritinib30 participants will complete: * Baseline visit with assessments and ECGs * Cycles 1 through 2 (28 days per cycle): --Day 1: Predetermined dose of Pacritinib 2x daily * Cycle 3, 6, 9, 12, and every 3 cycles for 48 cycles total (28 days per cycle): --Day 1: Predetermined dose of Pacritinib 2x daily * Bone marrow biopsies/aspirations at Cycles 6 and 12 and then yearly * End of Treatment visit with CT scan and bone marrow biopsy/aspiration * Follow up: every 12 weeks for 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥18 years
- ECOG performance status ≤2
- Clinicopathological diagnosis of Waldenström Macroglobulinemia
- Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:
- Serum IgM level ≥ 2 times the upper limit of normal
Key exclusion criteria (23 listed)
- Current history of uncontrolled HIV
- Patients with a known history of HIV must have a viral load assessed for eligibility and must be on a stable antiretroviral regimen that can be administered concurrent with pacritinib.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below
- Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)
- Participants who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 month after last study dose (2 weeks for breastfeeding)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacritinibAlso: SB1518, VONJO, Pacritinib CitrateKinase inhibitor, capsule, taken orally per protocol. | Drug | Pacritinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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.
20 secondary outcomes
Complete Response Rate
Time frame: Up to 48 months
Very Good Partial Response Rate
Time frame: Up to 48 months
Partial Response Rate
Time frame: Up to 48 months
Minimal Response Rate
Time frame: Up to 48 months
Stable Disease Rate
Time frame: Up to 48 months
Progressive Disease Rate
Time frame: Up to 48 months
Time to Response (TTR)
Time frame: Up to 48 months
Time to Major Response (TTMR)
Time frame: Up to 48 months
Median Progression-free Survival (PFS)
Time frame: Up to 48 months
Time to Next Treatment (TTNT)
Time frame: Up to 48 months
Median Overall Survival (OS)
Time frame: Up to 6 years
Bone marrow response
Time frame: Up to 48 months
Overall Response Rate Among Participants Without MYD88 Mutations
Time frame: Up to 48 months
Overall Response Rate Among Participants With MYD88 Mutations
Time frame: Up to 48 months
Overall Response Rate Among Participants Without CXCR4 Mutations
Time frame: Up to 48 months
Overall Response Rate Among Participants With CXCR4 Mutations
Time frame: Up to 48 months
Overall Response Rate Among Participants With TP53 Mutations
Time frame: Up to 48 months
Overall Response Rate Among Participants Without TP53 Mutations
Time frame: Up to 48 months
Number of Participants With Treatment-related Adverse Events
Time frame: Up to 48 months
Overall Response Rate Among Participants who progressed on covalent BTK-inhibitors
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shayna Sarosiek, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pacritinib in people with Waldenström Macroglobulinemia and Lymphoplasmacytic Lymphoma, run by Shayna Sarosiek, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shayna Sarosiek, MD (617-632-4218, Shayna_Sarosiek@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.