Peripheral T-Cell Lymphoma With Follicular Helper of T Cell PhenotypePhase 2NCT05572983
Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
A Phase 2 study testing Chidamide combined with CHOP and Chidamide in people with Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy of chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
- What is being tested?
- Chidamide combined with CHOP and Chidamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years old, male and female;
- Peripheral T-Cell lymphoma with follicular helper of T cell phenotype confirmed by histopathology at the study center, including: ① Angioimmunoblastic T-cell lymphoma (AITL), ②follicular T-cell lymphoma (FTCL), and ③ other nodal PTCL with TFH phenotype;
- Never received chemotherapy, radiotherapy, immunological and biological therapy for lymphoma before;
- Autologous stem cell transplantation is not suitable or the patient refused to accept autologous stem cell transplantation;
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography / computed tomography (PET/CT) or CT and/or MRI, intranode lesions with long diameter >1.5cm, short diameter >1.0cm, or exnode lesions with long diameter > 1.0 cm; PET CT examination of the lesion showing increased uptake in lymph nodes or extranodal areas (higher than liver) and imaging features consistent with lymphoma can be evaluated.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
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- Expected survival ≥ 3 months;
- The following required baseline laboratory data:
- .White blood cell，WBC≥3.0×109/L(Bone marrow invasive patient≥2.0×109/L), Absolute neutrophil count，ANC ≥1.5×109/L, （Bone marrow invasive patient≥1.0×109/L), Platelet count (PLT) ≥75×109/L, （Bone marrow invasive patient≥50×109/L) ，Hemoglobin (HB)≥ 80g/L;
- .Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (The liver invasion ≤3.0×ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN（The liver invasion≤5.0×ULN）
- .Renal function：creatinine, Cr≤1.5×ULN
- .Coagulation function： International Normalized Ratio (INR)≤1.5 ×ULN； Prothrombin Time (PT)、Activated Partial Thromboplastin Time (APTT)≤1.5×ULN（Unless the patient is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time）；
- .Thyroid stimulating hormone (TSH) or free thyroid hormone (FT4) or free triiodothyronine (FT3) were within 10% of normal value (note: abnormal TSH caused by non-autoimmune causes can be included in the group);
- Subjects fully understand and voluntarily participate in this study and sign informed consent
Who cannot join
- A history of other malignant tumors within the past 5 years; Or other tumors (except basal cell carcinoma of the skin)
- Patients with significant vital organ dysfunction;
- Patients with active bleeding or newly developed thrombotic disease, and patients who are taking anticoagulants and having a bleeding tendency;
- Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome;
- Patients with active chronic hepatitis B or active hepatitis C. Patients who are hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody positive during the screening period require further testing for Hepatitis B Virus (HBV) DNA and HCV RNA. If HBV DNA is no more than 2500 copies /mL or 500 IU/mL and HCV RNA is no more than the lower limit of the assay, enrollment will be allowed after exclusion of treatment-requiring active hepatitis B or C infection. Hepatitis B virus carriers, stable hepatitis B (no more than 2500 copies /mL or 500 IU/mL of DNA) and cured hepatitis C patients were eligible;
- Subjects who were treated with systemic glucocorticoids or other immunosuppressive agents for a condition within 14 days prior to initiation of study treatment {Local, ocular, intra-articular, intranasal, and inhaled glucocorticoids were allowed (with very low systemic absorption); Short-term (≤ 7 days) use of glucocorticoids for prophylactic treatment (e.g., contrast media allergy) or for treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) is allowed;
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- With active, and in the past two years need systemic treatment of autoimmune diseases (hormone replacement therapy is not considered a systemic treatment, such as type 1 diabetes, hypothyroidism only requiring thyroid hormone replacement therapy, low adrenocortical or pituitary function only requiring physiological doses of sugar cortical hormone replacement therapy ); Patients with autoimmune diseases that have not required systemic treatment in the past two years are eligible;
- Patients with unstable angina and/or congestive heart failure or vascular disease (such as, the aortic aneurysm or peripheral venous thrombosis requiring surgery to repair) requiring hospital treatment within 12 months. Patients with other cardiac damage (such as poor control of arrhythmia, myocardial infarction, or ischemic) which may affect the drug safety evaluation within 12 months;
- Patients who underwent major surgery within 28 days before enrollment; Less than 6 weeks after major organ surgery;
- Long-term unhealed wounds or incomplete healing fractures;
- Receive live attenuated vaccine (except influenza vaccine) within 4 weeks before enrollment or during the study period;
- Pregnant or lactating women and subjects of reproductive age who do not want to take contraceptive measures;
- Patients with mental illness or who cannot obtain informed consent;
- There is active infection, except for tumor-related B symptoms and fever;
- Cardiac clinical symptoms or diseases that are not well controlled, such as: I. Nyha grade 2 or above heart failure; II. Unstable angina pectoris; III. Myocardial infarction has occurred within 1 year; IV. Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Ineligibility to participate in the study was determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Qingqing Cai, MD, caiqq@sysucc.org.cn
About this study
Official title: Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype （SWIFT）
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy of chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype
- Being tested
- Chidamide combined with CHOP, Chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide combined with CHOPDrug
Also called Induction treatment
A)Chidamide: 20mg, D1, 4,8,11, po; B) Cyclophosphamide: 750 mg/ m2, D1, iv.drip; C) Doxorubicin: 50 mg/ m2, D1, iv.drip (or epirubicin 70 mg/ m2, D1, iv.drip); D) Vincristine: 1.4 mg/ m2, D1 (maximum dose 2mg, maximum dose 1.5mg for age over 70 years), iv; E) Prednisone: 40mg/m2, D1-5,po
ChidamideDrug
Also called Maintenance treatment
Chidamide: 20mg，qw（d1,d4）,po
| Study group | Role | What they receive |
|---|---|---|
| Chidamide in Combination With CHOP | Experimental | Patients with previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype will receive chidamide in combination with CHOP for 6 cycles (planned) (21 days per cycle). After 6 cycles of induction therapy, if complete remission (CR) was achieved, maintenance treatment with chidamide will be continued for two years. Receives: Drug: Chidamide combined with CHOP; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: Up to 18 weeks
Secondary outcomes (6)
Objective response rate
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: Up to 18 weeks
Partial remission rate
Partial remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: Up to 18 weeks
Progression-free survival（PFS）
To investigate the preliminary antitumor efficacy
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
To investigate the preliminary antitumor efficacy
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months
Recurrence free survival
To investigate the preliminary antitumor efficacy
Measured: From date of randomization until the date ofthe occurrence of relapse or last visit, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-Cell Lymphoma With Follicular Helper of T Cell PhenotypeStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
- Investigators
- Qingqing Cai, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572983
- Sponsor's protocol ID
- SL-B2022-485-02
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype （SWIFT）
- ClinicalTrials.gov ID
- NCT05572983
- Acronym / sponsor ID
- SL-B2022-485-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy of chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide in Combination With CHOP | Experimental | Drug: Chidamide combined with CHOP, Drug: ChidamidePatients with previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype will receive chidamide in combination with CHOP for 6 cycles (planned) (21 days per cycle). After 6 cycles of induction therapy, if complete remission (CR) was achieved, maintenance treatment with chidamide will be continued for two years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years old and ≤75 years old, male and female;
- Peripheral T-Cell lymphoma with follicular helper of T cell phenotype confirmed by histopathology at the study center, including: ① Angioimmunoblastic T-cell lymphoma (AITL), ②follicular T-cell lymphoma (FTCL), and ③ other nodal PTCL with TFH phenotype;
- Never received chemotherapy, radiotherapy, immunological and biological therapy for lymphoma before;
- Autologous stem cell transplantation is not suitable or the patient refused to accept autologous stem cell transplantation;
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography / computed tomography (PET/CT) or CT and/or MRI, intranode lesions with long diameter >1.5cm, short diameter >1.0cm, or exnode lesions with long diameter > 1.0 cm; PET CT examination of the lesion showing increased uptake in lymph nodes or extranodal areas (higher than liver) and imaging features consistent with lymphoma can be evaluated.
Key exclusion criteria (16 listed)
- A history of other malignant tumors within the past 5 years; Or other tumors (except basal cell carcinoma of the skin)
- Patients with significant vital organ dysfunction;
- Patients with active bleeding or newly developed thrombotic disease, and patients who are taking anticoagulants and having a bleeding tendency;
- Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome;
- Patients with active chronic hepatitis B or active hepatitis C. Patients who are hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody positive during the screening period require further testing for Hepatitis B Virus (HBV) DNA and HCV RNA. If HBV DNA is no more than 2500 copies /mL or 500 IU/mL and HCV RNA is no more than the lower limit of the assay, enrollment will be allowed after exclusion of treatment-requiring active hepatitis B or C infection. Hepatitis B virus carriers, stable hepatitis B (no more than 2500 copies /mL or 500 IU/mL of DNA) and cured hepatitis C patients were eligible;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide combined with CHOPAlso: Induction treatmentA)Chidamide: 20mg, D1, 4,8,11, po; B) Cyclophosphamide: 750 mg/ m2, D1, iv.drip; C) Doxorubicin: 50 mg/ m2, D1, iv.drip (or epirubicin 70 mg/ m2, D1, iv.drip); D) Vincristine: 1.4 mg/ m2, D1 (maximum dose 2mg, maximum dose 1.5mg for age over 70 years), iv; E) Prednisone: 40mg/m2, D1-5,po | Drug | Chidamide in Combination With CHOP |
| ChidamideAlso: Maintenance treatmentChidamide: 20mg，qw（d1,d4）,po | Drug | Chidamide in Combination With CHOP |
Primary outcome
Complete remission rate
Time frame: Up to 18 weeks
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
6 secondary outcomes
Objective response rate
Time frame: Up to 18 weeks
Partial remission rate
Time frame: Up to 18 weeks
Progression-free survival（PFS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months
Recurrence free survival
Time frame: From date of randomization until the date ofthe occurrence of relapse or last visit, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
Time frame: Up to 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingqing Cai study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide combined with CHOP and Chidamide in people with Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype, 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 14 inclusion and 16 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 10 Oct 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 Qingqing Cai (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.