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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide combined with CHOP | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | Up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | Up to 18 weeks |
| Partial remission rate | Partial remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. |
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Inclusion Criteria:
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;
Expected survival ≥ 3 months;
The following required baseline laboratory data:
Subjects fully understand and voluntarily participate in this study and sign informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qingqing Cai | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Chidamide | Drug | Chidamide: 20mg,qw(d1,d4),po |
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| Up to 18 weeks |
| Progression-free survival(PFS) | To investigate the preliminary antitumor efficacy | 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 | 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 | 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 | Up to 18 weeks |
| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D058850 | Opiate Substitution Treatment |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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