AzTrials
AzTrials

Relapsed/Refractory Non-Hodgkin LymphomaPhase 1/2NCT05320640

Study of Chidamide, Decitabine and Immune Checkpoint Inhibitors in R/R NHL and Advanced Solid Tumors

A Phase 1/2 study testing Chidamide, Decitabine and Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies） in people with Relapsed/Refractory Non-Hodgkin Lymphoma and Advanced Solid Tumors, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This phase I/II trial aims to evaluate safety and efficacy of Chidamide, Decitabine and Immune checkpoint inhibitors in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors. Read more about this study

Who is it for?
Ages 16 to 80 years
What is being tested?
Chidamide, Decitabine and Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
30 Mar 2022to 1 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 16 to 80 years of age.
  • ECOG performance of less than 3.
  • Life expectancy of at least 3 months.
  • Histopathological confirmed Non-Hodgkin Lymphoma and solid tumors.
  • Patients are relapsed/refractory Non-Hodgkin Lymphoma with ineligible for autologous hematopoietic stem cell transplantation.
  • The guidelines（ASCO/CSCO）recommend patients to participate in clinical trials.
  • Subjects must have at least one measureable target lesion.
  • Willingness to provide written informed consent for the study.

Who cannot join

  • Active, known or suspected autoimmune diseases.
  • Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
  • History of severe hypersensitive reactions to other monoclonal antibodies.
  • History of allergy or intolerance to study drug components.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.
Show all 11Show fewer
  • Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
  • History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
  • Vaccination within 30 days of study enrollment.
  • Active bleeding or known hemorrhagic tendency.

Trial locations and contacts

1 site in 1 country.

Weidong Han, Professor contact

+86-10-55499341

hanwdrsw@163.com

China1 site, 1 recruiting

  • Biotherapeutic Department, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Han wei dong, Ph.D, +86-10-55499341, hanwdrsw@163.com

    Recruiting

Other trials in China

About this study

Official title: A PhaseⅠ/Ⅱ Trial of Chidamide，Decitabine and Immune Checkpoint Inhibitors in Relapsed/Refractory Non-Hodgkin Lymphoma and Advanced Solid Tumors

This phase I/II trial aims to evaluate safety and efficacy of Chidamide, Decitabine and Immune checkpoint inhibitors in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.

Read the detailed description

Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Low-dose decitabine inhibits the activity of DNA methyltransferase, which can increase the expression of tumor antigens and HLA molecules, enhance antigen processing, promote T cell infiltration, and boost effector T cell function. Immune checkpoint inhibitors (ICIs) have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells. In conclusion, we speculate that the chemotherapy free regimen of Chidamide, Decitabine and Immune checkpoint inhibitors may explore a new avenue for therapeutic intervention in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.

Being tested
Chidamide, Decitabine, Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）
Keywords
Relapsed/Refractory Non-Hodgkin Lymphoma, Advanced Solid Tumors, Chidamide, Decitabine, Immune Checkpoint Inhibitors, Chemotherapy free regimen
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • ChidamideDrug

    Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance.

  • DecitabineDrug

    Low-dose decitabine inhibits the activity of DNA methyltransferase, which can increase tumor antigens and HLA expression, enhance antigen processing, promote T cell infiltration, and boost effector T cell function.

  • Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）Drug

    Immune checkpoint inhibitors (ICIs) have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells.

Study groups in NCT05320640
Study groupRoleWhat they receive
Experimental armExperimentalDrug: Chidamide10mg/day, day1-4; 20mg/day, day8, 11, 15, 18. Drug: Decitabine10mg/day, day1-5. Drug: Immune Checkpoint Inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）. Physicians will decide which ICIs will be used during treatment. Every 3 weeks.
Receives: Drug: Chidamide; Drug: Decitabine; Drug: Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies）

What is being measured

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

  1. Objective response rate (ORR)

    The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: 3 years

  2. Adverse events

    Incidence, nature, and severity of adverse events are graded according to the National Cancer Institute Common Terminology Criteria for adverse events (version5.0).

    Measured: 3 years

Secondary outcomes (2)

  1. Duration of response (DOR)

    Time from the first recording of CR or PR evidence to disease progression or death from any cause was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: 3 years

  2. Progression-free survival (PFS)

    Time from the date of first administration of the study drug to disease progression or death from any cause.

    Measured: 3 years

Timeline

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

  1. First posted11 Apr 2022
  2. Study start30 Mar 2022
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05320640
Sponsor's protocol ID
CHN-PLAGH-BT-069
Status last verified
Apr 2022
First submitted
2 Apr 2022
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chidamide, Decitabine and Immune checkpoint inhibitors（anti-PD1/PD-L1/CTLA4 antibodies） in people with Relapsed/Refractory Non-Hodgkin Lymphoma and Advanced Solid Tumors, run by Chinese PLA General Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

Contact Weidong Han, Professor (+86-10-55499341, hanwdrsw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 3 years). 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 NCT05320640.

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 11 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in