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Safety and EfficacyPhase 2NCT04994210

Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL

A Phase 2 study testing Sintilimab and Chidamide in people with Safety and Efficacy, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

ENKTL is a highly aggressive NHL with a higher incidence in Asia. L-asparaginase containing chemotherapy regimens are the standard first-line treatment with apparently toxicities. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Safety and Efficacy
What is being tested?
Sintilimab and Chidamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
4 Oct 2021to 31 Aug 2025
Phase
Phase 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
  • Aged 18-80 years old male or female;
  • Extranodal NK/T-cell lymphoma confirmed by histopathology examination;
  • Untreated,without any anti-lymphoma treatment;
  • Paraffin tissue specimens or fresh puncture tissue specimens are available;
  • Eastern cooperative oncology group score: 0-2;
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  • Estimated survival ≥ 12 months;
  • There must be at least one evaluate able or measurable lesion that meets the lymphoma response to immunomodulatory therapy criteria (LYRIC) [evaluable lesion: 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions > 15mm or extranodal lesions > 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver;
  • Adequate organ and bone marrow function, no severe hematopoietic dysfunction, cardiac, pulmonary, liver, kidney, thyroid dysfunction and immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other medical support was received within 14 days prior to the use of the research drug): 1) The absolute value of neutrophils (>1.0×10^9/L); 2) platelet count (> 75×10^9/L); 3) Hemoglobin (> 9 g/dL); 4) Upper Limit Normal (ULN) or creatinine clearance rate (>40 mL/min) of serum creatinine (<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%);
  • There was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%;
  • Participants must pass a pulmonary function test (PFT) to confirm that forced expiratory volume (FEV1)/forced vital capacity (FVC) in the first second is more than 60%, unless it is a large mediastinal mass caused by lymphoma that cannot meet this standard; carbon monoxide diffusion (DLCO), FEV1 and FVC are all above 50% of the predicted value; all PFT results must be obtained within four weeks before the first administration;
  • Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within seven days before the first medication and the results are negative. WOBCP or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF until six months after the last dose of the research drug is used

Who cannot join

  • Invasive natural killer cell leukemia;
  • Hemophagocytic syndrome;
  • Primary central nervous system lymphoma or secondary central nervous system involvement;
  • Relapsed or refractory ENKTL, accpeted any anti-ENKTL treatment;
  • Received organ transplantation in the past;
  • Participating in other clinical studies or planning to start this study is less than 4 weeks from the end of the previous clinical study;
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  • Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled;
  • Begin the study on subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given condition within 14 days before treatment [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens);
  • In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix;
  • Start the study and receive Chinese herbal medicine or Chinese patent medicine treatment within 7 days before treatment;
  • Begin research on live vaccination (except influenza attenuated vaccine) within 28 days before treatment;
  • History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
  • Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 500 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
  • Patients with active pulmonary tuberculosis;
  • Start studying any active infections requiring systemic anti-infective treatment within 14 days of treatment;
  • Pregnant or lactating women;
  • People with known history of alcoholism or drug abuse;
  • Have uncontrollable complications, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or hemorrhagic diseases;
  • History of interstitial lung disease or non-infectious pneumonia. Subjects who had previously had non-infectious pneumonia caused by drugs or radiation but had no symptoms were allowed to enter the group;
  • The QTcF interval is more than 450 msec, unless it is secondary to bundle branch block;
  • Past psychiatric history; incapacitated or restricted;
  • According to the researchers'judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions;
  • Other researchers consider it unsuitable for patients to participate in this study.

Trial locations and contacts

1 site in 1 country.

Nan-qiao Cai, Professor contact

+86 020-84115962

sysunsfc@mail.sysu.edu.cn

China1 site, 1 recruiting

  • SunYat-sen university cancer center

    Guangzhou

    Yan Gao

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Newly Diagnosed Extranodal Natural Killer Cell/T-cell Lymphoma(EN): A Single-arm, Multicenter Phase II Study(SCENT-2)

ENKTL is a highly aggressive NHL with a higher incidence in Asia. L-asparaginase containing chemotherapy regimens are the standard first-line treatment with apparently toxicities. In 2020 ASH, the investigators reported Sintilimab(anti-PD-1 antibody) plus Chidamide(an oral subtype-selective HDACi) yielded effective antitumor activity, durable response in patients with relapsed or refractory ENKTL(SCENT trial. Abstracts 644). The investigators next conducted a exploratory study to investigated the safety and efficacy of Sintilimab plus Chidamide(SC) for patients with newly diagnosed ENKTL(SCENT-2 trial).

Being tested
Sintilimab, Chidamide
Keywords
Sintilimab, Chidamide, refractory and relapsed, Extranodal natural killer cell/T-cell lymphoma
Medical subject headings
Recurrence

What participants receive

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

  • SintilimabDrug

    Also called Tyvyt®

    1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients
    2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients.
    3. Exploring biomarkers that may have predictive effects.

  • ChidamideDrug

    Also called Epidaza

    1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients
    2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients.
    3. Exploring biomarkers that may have predictive effects.
Study groups in NCT04994210
Study groupRoleWhat they receive
Sintilimab+ChidamideExperimentalSintilimab：200mg(fixed dosage), ivd, qd, q21d Chidamide: 30mg,biw,continued oral
Receives: Drug: Sintilimab; Drug: Chidamide

What is being measured

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

  1. Objective response rate (ORR) after end of treatment

    Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)

    Measured: up to 24 months

  2. Complete response rate (CRR) after end of treatment

    Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)

    Measured: up to 24 months

  3. Partial response rate (PRR) after end of treatment

    Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)

    Measured: up to 24 months

Secondary outcomes (9)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from the treatment date to the date of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.

    Measured: Time Frame: up to 36 months

  2. Overall Survival (OS)

    OS is defined as the time from treatment to the date of death.

    Measured: up to 36 months

  3. Duration of Response (DOR)

    Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the the lymphoma response to immunomodulatory therapy criteria (LYRIC) or death regardless of cause.

    Measured: up to 36 months

  4. Time to disease response (TTR)

    Among participants who experience an objective response, TTR is defined as the date of their first administration to the day of their first objective response (which is subsequently confirmed) per the RECIL 2017 Response Criteria for Malignant Lymphoma.

    Measured: up to 36 months

  5. Time to progression (TTP)

    Among all participants, TTP is defined as the date of their first administration to the day of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.

    Measured: Up to 36 months

  6. The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)

    An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.

    Measured: Up to 36 months

  7. Objective response rate (ORR) after sintilimab plus chidamide

    Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)

    Measured: up to 24 months

  8. Complete response rate (CRR) after sintilimab plus chidamide

    Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)

    Measured: up to 24 months

  9. Partial response rate (PRR) after sintilimab plus chidamide

    Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)

    Measured: up to 24 months

Timeline

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

  1. First posted6 Aug 2021
  2. Study start4 Oct 2021
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Aug 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04994210
Sponsor's protocol ID
SCENT-2
Status last verified
Apr 2022
First submitted
22 Jul 2021
Last updated
14 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab and Chidamide in people with Safety and Efficacy, run by Sun Yat-sen 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 12 inclusion and 23 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 14 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 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?

Results are not available in the source record.

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

Contact Nan-qiao Cai, Professor (+86 020-84115962, sysunsfc@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) after end of treatment (time frame: up to 24 months). The study lists 3 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 NCT04994210.

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 14 Apr 2022.

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