Is NCT04858256 recruiting in Durham, NC?

Yes, NCT04858256 is currently recruiting participants at its Durham, NC location. This t-cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the t-cell lymphoma clinical trial in Durham?

To join this clinical trial in Durham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Durham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

T-cell Lymphoma Clinical Trial in Durham, NC

Who Can Participate

Inclusion Criteria

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. Selected

Exclusion Criteria

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

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.

History of significant bleeding (≥ Grade 2 by CTCAE), bleeding diatheses, or bleeding complications within the past 3 months.

Hypersensitivity or allergic reaction to compounds related to pacritinib.

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.

Uncontrolled diarrhea. NOTE: patients with chronic diarrhea that is well controlled with supportive care measure (e.g. anti-motility agents) are eligible

Any gastrointestinal or metabolic condition that in the opinion of the investigator could interfere with the absorption of an oral medication.

Prior allogeneic stem-cell transplant.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT04858256) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

T-cell Lymphoma Treatment Options in Durham, NC

If you're searching for t-cell lymphoma treatment options in Durham, NC, this clinical trial (NCT04858256) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced t-cell lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all t-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

T-cell Lymphoma Clinical Trial in Durham, NC

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