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New treatment option for Peripheral T Cell Lymphoma
Official title Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma
ClinicalTrials.gov ID: NCT06151106
What this study is testing
What is Chidamide combined with Duvillisib?
Chidamide combined with Duvillisib is an investigational medicine, being studied as a potential treatment for peripheral t cell lymphoma.
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
- To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.
- Phase 2: a mid-size study of how well it works
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 75
You may be able to join if
- Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the classification standard of the World...
- Relapsed and refractory patients who have received at least first-line systemic treatment with anthracycline-containing drugs in the past. Recurrence...
- There must be at least one evaluable or measurable lesion meeting Lugano2014 standard: lymph node lesion and the measurable lymph node length should...
- Patients aged at 18-75 years old;
- ECOG 0-2
You likely can't join if
- Patients with central nervous system (CNS) or meningeal invasion
- Any of the following laboratory abnormalities: absolute neutrophil count (ANC) \ 1.5 upper limit of normal value (ULN), or AST or ALT \>2.5ULN...
- International normalized ratio (INR)\>1.5ULN or partially activated prothrombin time (APTT) \> 1.5 ULN
- The active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) should be excluded except for the...
- In patients with CMV infection (IgM positive), CMV DNA was positive by PCR.
- Meet any of the following criteria related to visceral function: all kinds of clinically significant abnormal rhythm or conduction need clinical...
See the full eligibility criteria
- Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the classification standard of the World Health Organization in 2008
- Relapsed and refractory patients who have received at least first-line systemic treatment with anthracycline-containing drugs in the past. Recurrence is defined as relapse after CR or progression after PR, SD. The...
- There must be at least one evaluable or measurable lesion meeting Lugano2014 standard: lymph node lesion and the measurable lymph node length should be \> 1.5cm;
- Patients aged at 18-75 years old;
- ECOG 0-2
- Routine blood examination: absolute neutrophil count ≥ 1.5× 10 9/L, platelet ≥ 75x10 9/L, Hb ≥ 80g/L.
- Expected survival ≥3 months 8 No radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation was received within 4 weeks before enrollment. 9\. The patient or his/her legal representative...
- Patients with central nervous system (CNS) or meningeal invasion
- Any of the following laboratory abnormalities: absolute neutrophil count (ANC) \ 1.5 upper limit of normal value (ULN), or AST or ALT \>2.5ULN, except the following situations. if patients with liver infiltrated by...
- International normalized ratio (INR)\>1.5ULN or partially activated prothrombin time (APTT) \> 1.5 ULN
- The active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) should be excluded except for the following patients: patients with HBV infection (HBsAg or HBcAg positive)...
- In patients with CMV infection (IgM positive), CMV DNA was positive by PCR.
- Meet any of the following criteria related to visceral function: all kinds of clinically significant abnormal rhythm or conduction need clinical pre-diagnosis Hereditary QT interval syndrome or QTcF\>480 msec or taking...
- Have a history of stroke or intracranial hemorrhage within 6 months before drug administration for the first time
- Major surgery was performed within 4 weeks before drug administration for the first study
- Any PI3K inhibitor has been used before and the disease has progressed during the treatment period (within 6 months after the last use)
- Received systemic anti-tumor therapy or radiotherapy within 4 weeks before the first study drug administration
- The last time you participated in clinical trials of other drugs before the administration of the first study drug was less than 2 weeks or the last time you used targeted drugs (such as antibody drugs) was less than 4...
- patients received the transplantation of somatic hematopoietic stem cells within 3 months before the first drug administration
- Patients received allogeneic hematopoietic stem cell transplantation or having any active graft-versus-host disease within 6 months before first drug administration.
- Take a strong inducer or inhibitor of cytochrome P4503A4 (CYP3A4) within 2 weeks before drug administration (3 weeks for Hypericum perforatum) for the first time.
- Before the first enrollment, the toxic reaction of previous anti-tumor therapy has not recovered to ≤1 level (except alopecia).
- Patients with uncontrolled systemic infection requiring intravenous antibiotic treatment
- Currently suffering from other primary tumors that need active treatment according to the guidelines
- Inability to take drugs orally, previous surgical history or serious gastrointestinal diseases such as dysphagia and active gastric ulcer may affect the absorption of drugs
- Pregnant (serum pregnancy test results are positive) or lactating women
- Any other diseases, abnormal metabolism, abnormal physical examination or abnormal laboratory examination with significant clinical significance, according to the researcher's judgment, it is reasonable to suspect that...
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, 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.