Is NCT06072131 recruiting in New Brunswick, NJ?

Yes, NCT06072131 is currently recruiting participants at its New Brunswick, NJ location. This peripheral t cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the peripheral t cell lymphoma clinical trial in New Brunswick?

To join this clinical trial in New Brunswick, 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 New Brunswick 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.

Peripheral T Cell Lymphoma Clinical Trial in New Brunswick, NJ

About This Peripheral T Cell Lymphoma Study in New Brunswick

Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study. Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups (Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated for up to

Sponsor: Acrotech Biopharma Inc.

Who Can Participate

Inclusion Criteria

Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility:

Pathology subtype:

Peripheral T-cell lymphoma, not otherwise specified

Angioimmunoblastic T-cell lymphoma

Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is contraindicated to receive BV.

Follicular T-cell lymphoma

Others: Extra-nodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma

CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation.

Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3)

Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2

For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by:

Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement

Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement

Total bilirubin ≤1.5 mg/dL

Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3×upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma)

Calculated creatinine clearance of ≥ 60 mL/min

Part 2 (Efficacy and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the following restrictions:

Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement

Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement

Total bilirubin ≤1.5 mg/dL

Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma)

Calculated creatinine clearance of ≥ 60 mL/min

UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation.

Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements

Patient (male or female) is at least 18 years of age at the time of informed consent

Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment.

Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.

Exclusion Criteria

A patient will not be eligible for inclusion if ANY of the criteria listed below apply:

Patients with a diagnosis of:

Precursor T-cell lymphoma or leukemia

Adult T-cell lymphoma/leukemia

T-cell prolymphocytic leukemia

T-cell large granular lymphocytic leukemia

Primary cutaneous type ALCL

Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome)

ALCL if they can be treated with Brentuximab Vedotin (BV)

Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat

Patient with an active concurrent malignancy/life-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years

Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy

Any known cardiac abnormalities such as baseline prolongation of QT/corrected QT (QTc) interval (i.e. demonstration of a QTc interval \>450 msec); long QT syndrome; myocardial infarction within 6 months prior to starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes

Patient with uncontrolled hypertension

Patients status on the following:

Has a known HIV-positive diagnosis with uncontrolled and detectable viral load

Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease

Patient with central nervous system metastasis

Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment

Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study

Patient with a known history of drug or alcohol abuse

Pregnant or breastfeeding women

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 New Brunswick?

Yes, this clinical trial (NCT06072131) has an active research site in New Brunswick, NJ 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.

Peripheral T Cell Lymphoma Treatment Options in New Brunswick, NJ

If you're searching for peripheral t cell lymphoma treatment options in New Brunswick, NJ, this clinical trial (NCT06072131) 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 New Brunswick research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced peripheral 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 peripheral t cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Peripheral T Cell Lymphoma Clinical Trial in New Brunswick, NJ

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