RECRUITING

Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

Conditions

T-Cell Neoplasm Lymphoproliferative Disorders pacritinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.

Official Title

Phase 2, Open Label, Multicenter Study of Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

Quick Facts

Study Start:2023-03-29

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04858256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and the willingness to sign a written informed consent. 2. ECOG performance status ≤ 2 3. A histologically confirmed diagnosis, per the WHO 2016 classification, of any PTCL or CTCL subtype listed in the protocol. 4. Relapsed or refractory disease. Refractory disease is defined as progression during treatment or recurrent/progressive disease within 6 months of completing a treatment regimen that achieved either stable disease or a PR/CR. Relapsed disease is defined as progression or recurrence at least 6 months after a prior documented response (PR or CR). 5. Adequate organ and hematopoietic function as defined in the protocol. 6. Sufficient archival tissue (15 unstained slides obtained within 90 days prior to registration) is required. If available, this tissue should be identified at screening and shipped prior to C2D1.If not available, a lymph node or tissue biopsy (core-needle or excisional) or skin biopsy (for CTCL) is required. The type of tissue obtained is at the discretion of the investigator based on disease. NOTE: If archival tissue is not available and a fresh biopsy is inaccessible or technically challenging (per site investigator discretion) at the site, the subject may be eligible for the study. 7. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is based on known history and local policies. 8. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is based on known history and local policies. 9. Ability to take oral medication without crushing, dissolving or chewing tablets. 10. In the investigator's opinion, the patient requires treatment, has an anticipated life expectancy of at least 3 months, and 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.	1. 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 2. Pregnant or breast feeding women 3. 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. 4. Uncontrolled current illness, including, but not limited to the following: 1. Ongoing or active infections requiring intravenous antimicrobials 2. Symptomatic congestive heart failure (CHF) defined as NYHA class II, III or IV (Appendix II), or ejection fraction \<45% in any patient. 3. Unstable angina pectoris within 6 months of study enrollment 4. Unstable cardiac arrhythmia 5. History of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment 6. Moderate to severe hepatic impairment (Child-Pugh class B or C). 7. Psychiatric illness or social situations that would limit compliance with study requirements. 5. Recent (within 21 days of initiation of therapy, day 1) major surgery 6. 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. 7. Use of systemic steroids at a dose equivalent to \>10 mg/day of prednisone 8. Prior treatment with pacritinib 9. Requires use of a medication that increases the risk of bleeding, including anticoagulation or antiplatelet therapy with the exception of aspirin at doses of ≤ 100mg daily. 10. History of significant bleeding (≥ Grade 2 by CTCAE), bleeding diatheses, or bleeding complications within the past 6 months. 11. Hypersensitivity or allergic reaction to compounds related to pacritinib. 12. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors (See Appendix III), for which no alternative is available. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors requires a washout period of 2 weeks prior to initiation of therapy, Cycle 1 Day 1. 13. Concurrent administration of QTc prolonging agents. Significant QTc prolonging agents must be stopped within 5 half-lives of Cycle 1 Day 1 (see Appendix IV). 14. Uncontrolled diarrhea. NOTE: patients with chronic diarrhea that is well controlled with supportive care measure (e.g. anti-motility agents) are eligible 15. Any gastrointestinal or metabolic condition that in the opinion of the investigator could interfere with the absorption of an oral medication. 16. Prior allogeneic stem-cell transplant.

Inclusion Criteria

Exclusion Criteria

1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and the willingness to sign a written informed consent.
2. ECOG performance status ≤ 2
3. A histologically confirmed diagnosis, per the WHO 2016 classification, of any PTCL or CTCL subtype listed in the protocol.
4. Relapsed or refractory disease. Refractory disease is defined as progression during treatment or recurrent/progressive disease within 6 months of completing a treatment regimen that achieved either stable disease or a PR/CR. Relapsed disease is defined as progression or recurrence at least 6 months after a prior documented response (PR or CR).
5. Adequate organ and hematopoietic function as defined in the protocol.
6. Sufficient archival tissue (15 unstained slides obtained within 90 days prior to registration) is required. If available, this tissue should be identified at screening and shipped prior to C2D1.If not available, a lymph node or tissue biopsy (core-needle or excisional) or skin biopsy (for CTCL) is required. The type of tissue obtained is at the discretion of the investigator based on disease. NOTE: If archival tissue is not available and a fresh biopsy is inaccessible or technically challenging (per site investigator discretion) at the site, the subject may be eligible for the study.
7. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is based on known history and local policies.
8. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is based on known history and local policies.
9. Ability to take oral medication without crushing, dissolving or chewing tablets.
10. In the investigator's opinion, the patient requires treatment, has an anticipated life expectancy of at least 3 months, and 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.

1. 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
2. Pregnant or breast feeding women
3. 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.
4. Uncontrolled current illness, including, but not limited to the following:
1. Ongoing or active infections requiring intravenous antimicrobials
2. Symptomatic congestive heart failure (CHF) defined as NYHA class II, III or IV (Appendix II), or ejection fraction \<45% in any patient.
3. Unstable angina pectoris within 6 months of study enrollment
4. Unstable cardiac arrhythmia
5. History of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment
6. Moderate to severe hepatic impairment (Child-Pugh class B or C).
7. Psychiatric illness or social situations that would limit compliance with study requirements.
5. Recent (within 21 days of initiation of therapy, day 1) major surgery
6. 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.
7. Use of systemic steroids at a dose equivalent to \>10 mg/day of prednisone
8. Prior treatment with pacritinib
9. Requires use of a medication that increases the risk of bleeding, including anticoagulation or antiplatelet therapy with the exception of aspirin at doses of ≤ 100mg daily.
10. History of significant bleeding (≥ Grade 2 by CTCAE), bleeding diatheses, or bleeding complications within the past 6 months.
11. Hypersensitivity or allergic reaction to compounds related to pacritinib.
12. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors (See Appendix III), for which no alternative is available. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors requires a washout period of 2 weeks prior to initiation of therapy, Cycle 1 Day 1.
13. Concurrent administration of QTc prolonging agents. Significant QTc prolonging agents must be stopped within 5 half-lives of Cycle 1 Day 1 (see Appendix IV).
14. Uncontrolled diarrhea. NOTE: patients with chronic diarrhea that is well controlled with supportive care measure (e.g. anti-motility agents) are eligible
15. Any gastrointestinal or metabolic condition that in the opinion of the investigator could interfere with the absorption of an oral medication.
16. Prior allogeneic stem-cell transplant.

Contacts and Locations

Principal Investigator

Ryan Wilcox, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109

United States

Duke Cancer Institute

Durham, North Carolina, 27710

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

Ryan Wilcox, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-29

Study Completion Date2028-11

Study Record Updates

Study Start Date2023-03-29

Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

pacritinib

Additional Relevant MeSH Terms

T-Cell Neoplasm
Lymphoproliferative Disorders