Trial Title:
Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma
NCT ID:
NCT06492629
Condition:
PTCL
Conditions: Official terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Intravenous infusion, 240mg, administered once every 3 weeks, until the subject has been
treated for 2 years, disease progression occurs, intolerable toxic reactions are
experienced, or treatment is discontinued for other reasons.
Arm group label:
Toripalimab Combined With Chidamide group
Intervention type:
Drug
Intervention name:
chidamide
Description:
Take 30 mg (6 tablets) each time, and take the medication twice a week, with at least 3
days between doses (such as on Monday and Thursday, Tuesday and Friday, Wednesday and
Saturday, etc.), to be taken 30 minutes after meals.
Arm group label:
Toripalimab Combined With Chidamide group
Summary:
To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of
relapsed/refractory peripheral T-cell lymphoma.
Detailed description:
The study is an open-label, single-arm, single-center, Phase II clinical trial. The trial
design adopts the Simon optimal two-stage design. The number of effective cases in the
first stage is 15; if fewer than 5 effective cases are observed, the trial will be
terminated, otherwise, the trial will continue. The total sample size for the trial is at
least 43 cases. All subjects receive treatment with the Toripalimab and Chidamide regimen
until the subject has been treated for 2 years, disease progression occurs, intolerable
toxic reactions occur, or treatment is terminated for other reasons, whichever comes
first. After the end of treatment, subjects are required to complete the end-of-treatment
visit within 7 days. Safety follow-up after the last dose is required at 30 days (±7
days) and 90 days (±7 days) after the last dose, with adverse event (AE) collection up to
90 days after the last dose. After the end of dosing, subjects enter the follow-up period
with a telephone follow-up every 12 weeks (±7 days) to collect survival information and
subsequent anti-tumor treatments until death or loss to follow-up. If a subject
discontinues treatment for reasons other than PD (progressive disease), efficacy
evaluation should continue at the same frequency as during the dosing period until the
subject experiences PD, starts a new anti-tumor treatment, dies, or is lost to follow-up.
Treatment should be continued as long as clinical benefit is observed, until the patient
is no longer tolerating it, for a maximum of 2 years of treatment. Atypical responses may
be observed (for example, a temporary increase in tumor size or the appearance of new
small lesions within the first few months, followed by a reduction in tumor size). If the
patient's clinical symptoms are stable or continue to improve, even with preliminary
evidence of disease progression, based on the overall judgment of clinical benefit, it
may be considered to continue treatment with this regimen until disease progression is
confirmed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years or older, both males and females are eligible;
2. Histologically confirmed peripheral T-cell lymphoma (PTCL) that has relapsed or is
refractory after at least one line of systemic therapy. The definitions are as
follows:
Relapse: Patients who achieved a Complete Response (CR) in previous treatments and
have new lesions at the original site or elsewhere; Refractory: Patients who did not
achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous
treatments must have included a chemotherapy regimen containing asparaginase;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. Expected survival of at least 3 months;
5. At least one measurable lesion in two dimensions, with the following criteria:
For intra-nodular lesions: Longest diameter >1.5 cm, shortest diameter >1.0 cm; For
extra-nodular lesions: Longest diameter >1.0 cm;
6. Adequate organ function as follows (no use of blood components or cytokines within
14 days before the first administration of the study drug): Hematology: Neutrophil
count (NEUT) ≥ 1.5 × 10^9/L, Platelet count (PLT) ≥ 75
- 10^9/L, Hemoglobin (HGB) ≥ 90 g/L; Liver function: Total serum bilirubin (TBIL)
≤ 1.5 × Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) and
Aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there is liver metastasis,
TBIL ≤ 3 × ULN, ALT and AST ≤ 5 × ULN; Renal function: Serum creatinine (Cr) ≤
1.5 × ULN; Thyroid function: Thyroid-stimulating hormone (TSH) within the
normal range; if TSH is abnormal, Free Triiodothyronine (FT3) and Free
Thyroxine (FT4) should be within the normal range or abnormal without clinical
significance;
7. Signed an informed consent form and is able to comply with the visits and procedures
specified in the protocol.
Exclusion Criteria:
1. Diagnosed with Adult T-cell Leukemia/Lymphoma (ATLL);
2. Confirmed central nervous system (CNS) infiltration of lymphoma, including brain
parenchymal invasion, meningeal involvement, or spinal cord compression;
3. T-cell lymphoma primarily starting extranodally in the skin, such as: Mycosis
Fungoides/Sezary Syndrome (MF/SS), primary cutaneous CD30-positive T-cell
lymphoproliferative disorders, primary cutaneous δγT-cell lymphoma, primary
cutaneous CD8-positive aggressive, epidermotropic cytotoxic T-cell lymphoma, primary
cutaneous acral CD8-positive T-cell lymphoma, lymphomatoid papulosis, primary
cutaneous CD4-positive small to medium T-cell lymphoproliferative disorders;
4. Patients who have previously used PD-1 monoclonal antibodies/PD-L1 monoclonal
antibodies or Chidamide;
5. Patients with certain specific past medical histories, such as active autoimmune
diseases, type 1 diabetes, thyroid hormone replacement required for hypothyroidism
(except Hashimoto's thyroiditis), severe mental illness;
6. Patients who require the use of immunosuppressants or systemic or absorbable local
hormone therapy for immunosuppressive purposes (dose >10mg/d prednisone or other
equivalent efficacy hormones) within 14 days before the first administration or
during the study;
7. Patients who have received radiotherapy, chemotherapy, hormone therapy, surgery,
targeted therapy, or systemic treatment with antibody drugs within 4 weeks before
the first administration; those who have used monoclonal antibody conjugated with
radioactive isotopes or cytotoxins within 10 weeks before the first administration;
patients who have not recovered to ≤grade 1 toxicity from previous anti-tumor
treatments (except for alopecia);
8. Patients with uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or
diastolic blood pressure ≥100mmHg);
9. Patients who have undergone autologous stem cell transplantation within 3 months
before the first administration;
10. Patients with a history of organ transplantation or allogeneic bone marrow
transplantation;
11. Patients who have received or plan to receive live attenuated vaccines within 4
weeks before the first administration or during the study;
12. Patients with a history of allergy to macromolecular protein preparations or
anti-PD-1 antibodies;
13. Patients with a history of or concurrent other malignant tumors (except for skin
basal cell carcinoma and cervical carcinoma in situ that have been cured for more
than 3 years);
14. Patients with uncontrollable or severe cardiovascular diseases, those who have had
New York Heart Association (NYHA) class II or above congestive heart failure,
unstable angina, myocardial infarction, and other cardiovascular diseases within 6
months before the first administration;
15. HIV-positive patients, or those with active hepatitis (for hepatitis B: reference to
hepatitis B five items and HBV-DNA, transaminases, etc., for hepatitis C: reference
to HCV antibodies and HCV RNA);
16. Patients who have received any other clinical trial drugs/devices within 4 weeks
before the first administration;
17. Patients with a history of drug abuse or alcoholism within 6 months before the first
administration;
18. Patients with a history of or concurrent interstitial lung disease (except for
interstitial lung disease caused by radiochemotherapy and currently asymptomatic);
19. Patients with active infections requiring systemic treatment;
20. Patients with active pulmonary tuberculosis infection;
21. Pregnant or lactating women;
22. Patients deemed unsuitable for enrollment by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
April 3, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06492629
