Is NCT07293403 recruiting in Duarte, CA?

Yes, NCT07293403 is currently recruiting participants at its Duarte, CA location. This follicular helper t-cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the follicular helper t-cell lymphoma clinical trial in Duarte?

To join this clinical trial in Duarte, 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 Duarte 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.

Follicular Helper T-Cell Lymphoma Clinical Trial in Duarte, CA

About This Follicular Helper T-Cell Lymphoma Study in Duarte

This phase II trial tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative.

Assent, when appropriate, will be obtained per institutional guidelines

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Histologically confirmed nodal T-follicular helper (TFH) cell lymphomas or PTCL-not otherwise specified (NOS). Nodal TFH cell lymphomas encompass three subtypes:

Angioimmunoblastic T-cell lymphoma (AITL)(World Health Organization 4th edition revised \[WHO4R\])/follicular helper T-cell lymphoma (TFH lymphoma), angioimmunoblastic type (International Consensus Classification \[ICC\])/nodal TFH cell lymphoma, angioimmunoblastic-type (World Health Organization 5th edition \[WHO5\])

Nodal PTCL with TFH phenotype (nodal PTCL, TFH)(WHO4R)/TFH lymphoma, NOS (ICC)/nodal TFH cell lymphoma, NOS (WHO5)

Follicular T-cell lymphoma (FTCL)(WHO4R)/TFH lymphoma, follicular type (ICC)/ nodal TFH cell lymphoma, follicular-type (WHO5)

Completion of first-line multi-agent chemotherapy with a cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-based regimen and documentation of complete response (CR) per Lugano criteria within the previous 6 months prior to enrollment. Prior corticosteroid monotherapy is not considered a line of therapy

Ineligible for or decline consolidative autologous stem cell transplantation. Ineligibility is defined by:

Patient deemed ineligible for high-dose chemotherapy and ASCT based on physician's assessment

AND at least one of the following criteria:

Age ≥ 65 years or

Age ≥ 18 years and Hematopoietic Cell Transplantation-specific Comorbidity Index score ≥ 3

Recovery to ≤ grade 1 or baseline for any toxicities due to prior treatments, with the exception of peripheral neuropathy (recovery to ≤ grade 2) or alopecia

Platelets ≥ 25,000/mm\^3

Hemoglobin ≥ 8 g/dL

CD4 lymphocyte count ≥ 50/mm\^3 (0.05 × 10\^9/L)

Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in patients with Gilbert's Syndrome a bilirubin \> 1.5 × ULN but ≤ 3 × ULN may be allowed with sponsor approval)

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 2.5 × ULN

Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 × ULN

Serum creatinine ≤ 2.0 × ULN or creatinine clearance ≥ 30 mL/min (estimated by Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] or Cockcroft-Gault equation or measured)

Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR patients with presence of hepatitis B core antibody (HBcAb), but absence of hepatitis B surface antigen (HBsAg), are eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable (\< 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)

Women of childbearing potential (WOCBP): negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months. Women who are considered not to be of childbearing potential are not required to have a pregnancy test

Agreement by females and males of reproductive potential (i.e., not surgically sterile or female patients who are not postmenopausal) must be willing to use a highly effective method of contraception for the duration of study treatment and for at least 1 months after the last dose of duvelisib

Exclusion Criteria

Prior organ transplantation

Major surgery within 4 weeks prior to enrollment

Administration of a live vaccine within 30 days of cycle (C) 1 day (D) 1

Unable to receive prophylactic treatment for pneumocystis at enrollment

Use of medications or consumption of foods that are strong inducers or inhibitors of CYP3A must be discontinued at least 2 weeks prior to study intervention. Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions

Known central nervous system involvement by PTCL

Patients with known diagnosis of

Active cytomegalovirus (CMV) infection (patients with detectable viral load)

History of tuberculosis treatment within 2 years prior to enrollment

Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1

If a patient has signs/symptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (e.g., polymerase chain reaction \[PCR\]) test or 2 negative antigen test results at least 24 hours apart. Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only be rescreened if the following have been met:

At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms

History of cirrhosis or chronic alcohol abuse

Symptomatic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of duvelisib

Concurrent active malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver: nonmelanoma skin cancer, carcinoma in situ of the cervix

Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, such as pulmonary disease, including obstructive pulmonary disease and history of bronchospasm, uncontrolled diabetes, severe psychiatric disorder or unstable cardiac disease as defined by one of the following:

Cardiac events such as myocardial infarction (MI), stroke or unstable angina within the past 6 months

New York Heart Association (NYHA) heart failure class III-IV

Uncontrolled atrial fibrillation or hypertension

History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block

History of allergic reactions attributed to compounds of similar chemical or biologic composition to duvelisib

Participants who are receiving other investigational agents

Female patients who are breastfeeding

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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 Duarte?

Yes, this clinical trial (NCT07293403) has an active research site in Duarte, CA 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.

Follicular Helper T-Cell Lymphoma Treatment Options in Duarte, CA

If you're searching for follicular helper t-cell lymphoma treatment options in Duarte, CA, this clinical trial (NCT07293403) 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 Duarte research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced follicular helper 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 follicular helper t-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Follicular Helper T-Cell Lymphoma Clinical Trial in Duarte, CA

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