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Peripheral T Cell LymphomaPhase 2NCT06151106

Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma

A Phase 2 study testing Chidamide combined with Duvillisib in people with Peripheral T Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Chidamide combined with Duvillisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
22 Nov 2023to 25 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 refractory disease was defined as previous systemic chemotherapy, PD in response evaluation for 2 cycles or SD in response evaluation for 4 cycles.
  • 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 must provide written informed consent before carrying out any special inspection or procedure of the study.

Who cannot join

  • Patients with central nervous system (CNS) or meningeal invasion
  • Any of the following laboratory abnormalities: absolute neutrophil count (ANC) < 1.5× 10*9/L, Hb< 80 g/L, PLT < 75×10 9 /L, organ dysfunction, are defined as follows: total bilirubin (TBiL) > 1.5 upper limit of normal value (ULN), or AST or ALT >2.5ULN, except the following situations. if patients with liver infiltrated by lymphoma cells, AST and ALT < 5ULN could be enrolled.
  • 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) but HBV DNA negative. These patients need continuous antiviral treatment and HBV DNA PCR detection every cycle. additionally, patients with HCV serology positive but HCV RNA negative can be enrolled.
  • 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 drugs that may cause Qt interval delay or torsade de pointes. A variety of clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, and coronary artery bypass grafting in the first 6 months of the group, with New York's cardiology (NYHA) classification of grade 3 or above. Left ventricular ejection fraction (LVEF )<40%, or uncontrolled blood pressure controlled by drugs (Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mgHg).
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  • 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 weeks
  • 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 patient has a certain disease or state that is not suitable for using these two drugs, or it will affect the interpretation of the research results or put the patient in a high-risk situation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bing Xu contact

+8618750918842

xubingzhangjian@126.com

Zhifeng Li contact

+8613606901162

lzf_xm@163.com

China1 site, 1 recruiting

  • The First Affiliated Hosptial of Xiamen University

    Xiamen, Fujian, 361000

    Bing Xu, phD, +8618750918842, xubingzhangjian@126.com

    Zhifeng Li, +8613606901162, lzf_xm@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Prospective and Single-arm Clinical Study on the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma (R/R PTCL) With Chidamide and Duvalisib

To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.

Read the detailed description

This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (Overall Response Rate, Complete Response, Partial Response, Overall Survival, Progression Free Survival) and adverse effects of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.

Being tested
Chidamide combined with Duvillisib
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chidamide combined with DuvillisibDrug

    Specified dose on specified days

Study groups in NCT06151106
Study groupRoleWhat they receive
Chidamide combined with DuvillisibExperimentalNot described
Receives: Drug: Chidamide combined with Duvillisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.

    Measured: Up to 27 months

  2. Complete Response Rate

    Complete response (CR) is evaluated according to the Lugano criteria for lymphoma response.

    Measured: Up to 27 months

Secondary outcomes (3)

  1. Partial Response Rate

    Partial response (PR) is evaluated according to the Lugano criteria for lymphoma response.

    Measured: Up to 27 months

  2. Progression Free Survival

    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

    Measured: Up to 27 months

  3. Overall Survival

    OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.

    Measured: Up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2023
  2. Study start22 Nov 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion25 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06151106
Sponsor's protocol ID
XMDYYYXYK-02
Status last verified
Feb 2025
First submitted
21 Nov 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide combined with Duvillisib in people with Peripheral T Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bing Xu (+8618750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06151106.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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