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New treatment option for Lymphoma, T-Cell, Peripheral
Official title Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
ClinicalTrials.gov ID: NCT06947967
What this study is testing
What is CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)?
CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma, t-cell, peripheral.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Provide written informed consent for the study.
- Male or female, age ≥ 18 years and ≤80 years.
- ECOG PS 0,1 or 2.
- Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic...
- At least one measurable disease according to the Lugano 2014 Classification.
You likely can't join if
- Presence of CNS involvement.
- Received prior therapies targeting lymphoma.
- Participants planned for autologous or allogeneic transplant as consolidation after CR.
- Participants with any other malignancy in past 5 years, except for local tumors that have been cured.
- Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).
- Any investigational therapy within 3 months.
See the full eligibility criteria
- Provide written informed consent for the study.
- Male or female, age ≥ 18 years and ≤80 years.
- ECOG PS 0,1 or 2.
- Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic T-cell lymphoma, b. follicular helper T-cell lymphoma, follicular type...
- At least one measurable disease according to the Lugano 2014 Classification.
- Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study...
- Presence of CNS involvement.
- Received prior therapies targeting lymphoma.
- Participants planned for autologous or allogeneic transplant as consolidation after CR.
- Participants with any other malignancy in past 5 years, except for local tumors that have been cured.
- Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).
- Any investigational therapy within 3 months.
- Contraindication to any of the individual components of CHOP.
- Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control, and the following conditions for inclusion must be met, a. participants receiving corticosteroid treatment...
- Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.
- Have uncontrolled or significant cardiovascular disease, including a. Grade Ⅱ or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification )...
- History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.
- Participants with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.
- History of deep vein thrombosis or pulmonary embolism.
- History of active bleeding within 2 months prior to the start of Cycle 1;or participants receiving anticoagulation therapy; or participants with evidence of bleeding potential according to investigators' judgment (...
- Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures were performed within 4 weeks. Tissue biopsy or other minor surgical procedure (other than venipuncture...
- Active infection requiring systemic treatment (oral, intravenous infusion) was present within 2 weeks prior to the first dose. Participants receiving prophylactic antibiotic therapy (e.g., interstitial pneumonia) may be...
- HBsAg or HBcAb positive with virus replication (except for virus replication positive that non-active hepatitis B assessed by investigators), HCV-Ab positive with virus replication positive, active syphilis infection...
- History of HIV infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or stem cell transplantation.
- Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements/ treatment.
- Drug or alcohol abuse.
- Women patients of childbearing potential who are unwilling or unable to use an effective method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of tucidinostat/placebo...
- Any other condition which is inappropriate for the study according to investigators' judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.