Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center
About this trial
The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Ongoing or active infections requiring intravenous antimicrobials
Trial design
Design model
Parallel
Treatments tested in this trial
Pacritinib
DrugPacritinib will be dosed at 200mg twice daily.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: PTCL, NOSExperimental treatment 1 intervention
Group B: Cohort 2: AITL/TFH PTCLExperimental treatment 1 intervention
Group C: Cohort 3: CTCL (MF/SS)Experimental treatment 1 intervention
Group D: Cohort 4: Less common PTCL subtypesExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 2 yearsSecondary outcomes
1
Complete response rate (CRR)
CRR is defined as the percentage of PTCL patients who have a best response of CR per the RECIL criteria and percentage of CTCL who a have a best response of CR per the modified Severity Weighted Assessment Tool (mSWAT). CR rate will be analyzed by cohort and summarized with "time-to-event" analysis.
Time frame
Up to approximately 5 years2
Duration of response (DOR)
DOR is defined as time from first observed response (CR or PR) to date of progression (PD) or death, whichever occurs first. DOR will be analyzed by cohort with "time-to-event" analysis.
Time frame
Up to approximately 5 years3
Time to next treatment (TTNT)
TTNT is defined as time from first dose of pacritinib to initiation of alternative systemic, antineoplastic therapy. TTNT will be analyzed by cohort using a "time-to-event" analysis.
Time frame
Up to approximately 5 years4
Progression- free survival (PFS).
PFS is defined as the time from first day of treatment to date of disease progression (PD) or death, whichever occurs first. Patients who survive without progression will be censored on the date of last evaluable tumor assessment. PFS will be analyzed by cohort and summarized with "time-to-event analysis.
Time frame
Up to approximately 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan Rogel Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Hoosier Cancer Research Network
Collaborator
CTI BioPharma
Collaborator
Source ClinicalTrials.gov