Lymphoma, T-Cell, CutaneousPhase 1NCT03601819
Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
A Phase 1 study testing Pacritinib in people with Lymphoma, T-Cell, Cutaneous and Lymphoma, T-Cell, Peripheral, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This trial will determine the safety and tolerability of Pacritinib in patients with relapsed/refractory lymphoproliferative disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Chronic Lymphocytic Leukemia
- What is being tested?
- Pacritinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 17 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Diagnosis of any of the following:
- Relapsed/refractory cutaneous (stage IIb-IV by ISCL/EORTC staging criteria) or peripheral T-cell lymphoma with progression after the last line of therapy and refractory to/intolerant of or have a contraindication to all established therapies known to provide clinical benefit (including brentuximab vedotin for patients with anaplastic large cell lymphomas) OR
- Chronic lymphocytic leukemia (CLL), splenic marginal zone lymphoma (SMZL), Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) or mantle cell lymphoma (MCL) with disease progression on ibrutinib or who discontinue ibrutinib due to toxicity/intolerance. In addition, patients should be refractory to/intolerant of or have a contraindication to all established therapies known to provide clinical benefit OR
- Any lymphoproliferative disorder who have failed at least 2 prior therapies and are refractory to/intolerant of or have a contraindication to all established therapies known to provide clinical benefit and have had mutational analysis or sequencing studies performed in a CLIA certified laboratory demonstrating a mutation or gene fusion involving MyD88, JAK2, JAK3, TYK2, or IRAK1 that are known or suspected to be "activating" (gain-of-function).
- Age ≥ 18 at time of enrollment
- ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
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- Adequate organ and marrow function as defined in the protocol
- Ability to take oral medication without crushing, dissolving or chewing tablets.
- In the investigator's opinion, the patient requires immediate treatment.
- Ability to understand and the willingness to sign a written informed consent.
- In the investigator's opinion, the patient has the ability to communicate satisfactorily with the investigator and the study team, to participate fully in the study, and comply with all requirements.
Who cannot join
- History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
- Pregnant or breast feeding women
- Unwilling or unable to use a medically acceptable form of contraception during the time of participation in the trial (sexual abstinence is permissible) unless documented successful vasectomy, hysterectomy, bilateral oophorectomy or post-menopausal for at least 2 years
- Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class II, III or IV (Appendix II); unstable angina pectoris within 6 months of study enrollment; unstable cardiac arrhythmia; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
- Known HIV infection
- Known positive Hepatitis B surface antigen or Hep C virus
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- Recent (within 21 days of initiation of therapy, day 1) major surgery
- Less than 14 days have elapsed since last radiation therapy or chemotherapy treatment or patient has not recovered from all clinically significant treatment-related toxicity; less than 90 days have passed since date of autologous stem cell transplant and patient has not recovered to ≤grade 1 toxicity related to this procedure
- Use of systemic steroids (oral, inhaled, nasal, topical) at a dose less > 10 mg/day of prednisone
- Prior treatment with pacritinib
- Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP). Coombs positivity in absence of hemolysis is not an exclusion.
- Requires anticoagulation with heparin, warfarin or equivalent Vit K antagonist
- History of significant bleeding (≥Grade 2 by CTCAE) history or complications (including bleeding that may have occurred while on ibrutinib)
- Hypersensitivity or allergic reaction to compounds related to pacritinib
- Treatment with potent CYP450 inducers and strong CYP3A4 inhibitors for which no alternative is available; treatment with strong CYP450 inducers or strong CYP3A4 inhibitors within 2 weeks of initiation of therapy, day 1
- Concurrent administration of QTc prolonging agents; significant QTc prolonging agents must be stopped within 5 half-lives of day 1.
- Any gastrointestinal or metabolic condition that could interfere with the absorption of oral medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase Ib, Open Label, Single Center Study of Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
This trial will determine the safety and tolerability of Pacritinib in patients with relapsed/refractory lymphoproliferative disorders.
- Conditions
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Chronic Lymphocytic Leukemia, Lymphoproliferative Disorders, Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
- Being tested
- Pacritinib
- Keywords
- Relapsed, Refractory, MyD88, JAK2, JAK3, TYK2, IRAK1, CLL, SMZL, LPL, WM, MCL, CTCL, PTCL
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoproliferative Disorders, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
Patients will receive continuous treatment until progressive disease, toxicity, or until any other condition for treatment discontinuation has been met.
| Study group | Role | What they receive |
|---|---|---|
| Pacritinib | Experimental | 200 mg twice daily (with possible dose reduction to 100 mg twice daily) Receives: Drug: Pacritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities (DLT)
Dose limiting toxicity (DLT) rate during the 1st cycle (28 days) of pacritinib.
Measured: At 28 days
Secondary outcomes (4)
The proportion of patients that respond to treatment
Overall response rate (ORR), defined as best disease response recorded from first day of treatment until disease progression or initiation of new antineoplastic therapy.
Responses for patients with NHL or small lymphocytic lymphoma will be performed in accordance with the Revised Lugano classification staging system for non-Hodgkin's Lymphoma. Responses for patients with CLL will be evaluated in accordance with criteria of the International Workshop on Chronic Lymphocytic Leukemia, with the exception that lymphocytosis will not be the sole criteria for disease progression. Responses for CTCL will be assessed by the modified Severity Weighted Assessment Tool, response in blood, nodes, viscera, and the global composite scoring system.
Measured: Up to 2 years
The proportion of patients that experience a complete response (CR)
Responses for patients with NHL or small lymphocytic lymphoma will be performed in accordance with the Revised Lugano classification staging system for non-Hodgkin's Lymphoma. Responses for patients with CLL will be evaluated in accordance with criteria of the International Workshop on Chronic Lymphocytic Leukemia, with the exception that lymphocytosis will not be the sole criteria for disease progression. Responses for CTCL will be assessed by the modified Severity Weighted Assessment Tool, response in blood, nodes, viscera, and the global composite scoring system.
Measured: Up to 2 years
Duration of response (DOR)
DOR, defined as time from documented remission to the time of death, relapse, or initiation of alternative antineoplastic.
Responses for patients with NHL or small lymphocytic lymphoma will be performed in accordance with the Revised Lugano classification staging system for non-Hodgkin's Lymphoma. Responses for patients with CLL will be evaluated in accordance with criteria of the International Workshop on Chronic Lymphocytic Leukemia, with the exception that lymphocytosis will not be the sole criteria for disease progression. Responses for CTCL will be assessed by the modified Severity Weighted Assessment Tool, response in blood, nodes, viscera, and the global composite scoring system.
Measured: Up to 2 years
Time to next treatment
Time to next treatment, defined as time from first dose of pacritinib to initiation of alternative antineoplastic therapy
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 May 2019
- Primary completion7 Mar 2020
- Study completion17 Jul 2020
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, CutaneousStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Wilcox, MD, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601819
- Sponsor's protocol ID
- UMCC 2018.048
- Other IDs
- HUM00144759
- Status last verified
- Jan 2021
- First submitted
- 18 Jul 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Open Label, Single Center Study of Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT03601819
- Acronym / sponsor ID
- UMCC 2018.048
- Conditions
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Chronic Lymphocytic Leukemia, Lymphoproliferative Disorders, Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
- Keywords
- Relapsed, Refractory, MyD88, JAK2, JAK3, TYK2, IRAK1, CLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 26 Jul 2018 (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 trial will determine the safety and tolerability of Pacritinib in patients with relapsed/refractory lymphoproliferative disorders.
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: Pacritinib200 mg twice daily (with possible dose reduction to 100 mg twice daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of any of the following:
- Age ≥ 18 at time of enrollment
- ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
- Adequate organ and marrow function as defined in the protocol
- Ability to take oral medication without crushing, dissolving or chewing tablets.
Key exclusion criteria (17 listed)
- History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
- Pregnant or breast feeding women
- Unwilling or unable to use a medically acceptable form of contraception during the time of participation in the trial (sexual abstinence is permissible) unless documented successful vasectomy, hysterectomy, bilateral oophorectomy or post-menopausal for at least 2 years
- Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class II, III or IV (Appendix II); unstable angina pectoris within 6 months of study enrollment; unstable cardiac arrhythmia; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
- Known HIV infection
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 |
|---|---|---|
| PacritinibPatients will receive continuous treatment until progressive disease, toxicity, or until any other condition for treatment discontinuation has been met. | Drug | Pacritinib |
Primary outcome
Rate of dose limiting toxicities (DLT)
Time frame: At 28 days
Dose limiting toxicity (DLT) rate during the 1st cycle (28 days) of pacritinib.
4 secondary outcomes
The proportion of patients that respond to treatment
Time frame: Up to 2 years
The proportion of patients that experience a complete response (CR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Time to next treatment
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ryan Wilcox, MD, PhD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pacritinib in people with Lymphoma, T-Cell, Cutaneous and Lymphoma, T-Cell, Peripheral, run by University of Michigan Rogel Cancer Center 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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 22 Jan 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dose limiting toxicities (DLT) (time frame: At 28 days). 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 22 Jan 2021.