Is NCT06561048 recruiting in New Haven, CT?

Yes, NCT06561048 is currently recruiting participants at its New Haven, CT location. This peripheral t-cell lymphoma, not otherwise specified clinical trial is actively enrolling qualified participants.

Is participation in this New Haven 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, Not Otherwise Specified Clinical Trial in New Haven, CT

Q: How do I join the peripheral t-cell lymphoma, not otherwise specified clinical trial in New Haven?

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

About This Peripheral T-Cell Lymphoma, Not Otherwise Specified Study in New Haven

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Sponsor: Corvus Pharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

Adult participants ≥18 years of age on the day of signing the informed consent form.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.

Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.

Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.

Life expectancy \>12 weeks.

Adequate organ function as determined by:

Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)

Platelet count ≥ 100×10\^9/L (without transfusion)

Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug

Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants

Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute

Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor

Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)

Serum albumin \> 2.5 g/dL

Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN

Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:

Grade ≤ 2 neuropathy

Alopecia and non-acute toxicities

If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment

Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.

Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.

Exclusion Criteria

Participants who have T-cell lymphoma with active central nervous system involvement.

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.

History of primary immunodeficiency or sold organ transplantation.

History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.

Any active infection requiring IV therapy.

History of invasive prior malignancy that required systemic therapy within last 3 years.

Any condition that confounds the ability to interpret data from the study.

Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\]) or positive test for hepatitis C antibody.

Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.

Prior administration of an ITK inhibitor.

Participants who need immediate cytoreductive therapy.

Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.

History of allogeneic hematopoietic stem cell transplantation.

Candidate for hematopoietic stem cell transplantation at screening.

History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.

Concurrent enrollment in another clinical study

Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.

Participants who cannot ingest medications orally or who have malabsorption.

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 Haven?

Yes, this clinical trial (NCT06561048) has an active research site in New Haven, CT 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, Not Otherwise Specified Treatment Options in New Haven, CT

If you're searching for peripheral t-cell lymphoma, not otherwise specified treatment options in New Haven, CT, this clinical trial (NCT06561048) 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 Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced peripheral t-cell lymphoma, not otherwise specified 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, not otherwise specified clinical trials near you to find additional studies recruiting in your area.

Peripheral T-Cell Lymphoma, Not Otherwise Specified Clinical Trial in New Haven, CT

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