Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

NCT04858256 | Recruiting Phase 2 FDA Drug

• 4 other identifiers: UMCC 2020.064R01CA265929HUM00184365HCRN LYM21-544
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

T-Cell Neoplasm; Lymphoproliferative Disorders

Keywords

pacritinib

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  ORR will be estimated for each disease-specific cohort of patients. Overall response is defined as best disease response recorded from first day of treatment until disease progression or treatment discontinuation. Response in PTCL patients is assessed by PET/CT scan using the Response Evaluation Criteria in Lymphoma (RECIL) criteria. Response in CTCL patients is assessed using the modified Severity Weighted Assessment Tool (mSWAT). Results will be stratified by type: complete response \[CR\], partial response \[PR\], minor response \[MR; a provisional category in RECIL only\], stable disease \[SD\], progressive disease \[PD\]; and by cohort.

  Up to 2 years

Secondary Outcomes (5)

• Complete response rate (CRR)

  Up to approximately 5 years

• Duration of response (DOR)

  Up to approximately 5 years

• Time to next treatment (TTNT)

  Up to approximately 5 years

• Progression- free survival (PFS).

  Up to approximately 5 years

• Treatment related toxicities >=grade 3

  30 days post end of treatment (+4 days)

Study Arms (4)

Cohort 1: PTCL, NOS

EXPERIMENTAL

Patients will receive single agent pacritinib.

Drug: Pacritinib

Cohort 2: AITL/TFH PTCL

EXPERIMENTAL

Patients will receive single agent pacritinib.

Drug: Pacritinib

Cohort 3: CTCL (MF/SS)

EXPERIMENTAL

Patients will receive single agent pacritinib.

Drug: Pacritinib

Cohort 4: Less common PTCL subtypes

EXPERIMENTAL

Patients will receive single agent pacritinib.

Drug: Pacritinib

Interventions

Pacritinib DRUG

Pacritinib will be dosed at 200mg twice daily.

Cohort 1: PTCL, NOS; Cohort 2: AITL/TFH PTCL; Cohort 3: CTCL (MF/SS); Cohort 4: Less common PTCL subtypes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG performance status ≤ 2
• A histologically confirmed diagnosis, per the WHO 2016 classification, of any PTCL or CTCL subtype listed in the protocol.
• 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).
• Adequate organ and hematopoietic function as defined in the protocol.
• 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.
• 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.
• 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.
• Ability to take oral medication without crushing, dissolving or chewing tablets.
• 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.

You may not qualify if:

• 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. NOTE: women may not breast feed or store breast milk during treatment and for 3 months after pacritinib discontinuation.
• 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. Women of childbearing potential must use highly effective methods of birth control from the time of informed consent, for the duration of pacritinib treatment and for 30 days after discontinuation of pacritinib. This timeframe also applies to breast-feeding and egg donation. Fertile males must use contraception from the time of study treatment initiation, for the duration of pacritinib treatment and for 30 days after discontinuation of pacritinib. This timeframe is also applicable to sperm donation. Participants should be informed of the risk of unintended pregnancy due to potential reduced effectiveness of hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin) during treatment with pacritinib.
• Uncontrolled current illness, including, but not limited to the following:
• Ongoing or active infections requiring intravenous antimicrobials
• Symptomatic congestive heart failure (CHF) defined as NYHA class II, III or IV (Appendix II), or ejection fraction \<45% in any patient.
• 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.
• 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 at a dose equivalent to \>10 mg/day of prednisone
• Prior treatment with pacritinib

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Hoosier Cancer Research Network: collaborator
• CTI BioPharma: collaborator

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoproliferative Disorders

Interventions

11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ryan Wilcox, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each of the four disease-based cohorts will be run in parallel, independently, and under an identical two-stage design.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 26, 2021
• Study Start: March 29, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)