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临床试验/NCT05230680
NCT05230680招募中1 期

Multicenter, Open Label, Phase I/II of Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype

Won Seog Kim1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年7月1日最近更新:
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适应症
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
41
试验地点
1
主要终点
complete response rate
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Induction treatment (every 3 weeks, total 6 cycles)

  • Azacitidine D-2, -1, 1 (level 1: 50mg/m2, level 2: 75mg/m2, level 3: 100mg/m2, level 4: 125mg/m2)
  • Cyclophosphamide 750mg/m2 d1
  • Doxorubicin 50 mg/m2 d1
  • Vincristine 1.4 mg/m2 (Max: 2 mg) d1
  • Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total 12 cycles)
  • Azacitidine 75mg/m2 d1-5

详细描述

  1. Phase I Azacitidine will be administered intravenously from d-2 to d1, starting from dose level 1. Based on the BOIN design described above, if no DLT is identified in level 1, the dose will be escalated stepwise to levels 2, 3, and then 4.

Subjects will receive intravenous azacitidine combined with CHOP regimen every 3 weeks as below:

Level 1 - Azacitidine 50mg/m2 D-2, -1, 1 Level 2 - Azacitidine 75mg/m2 D-2, -1, 1 Level 3 - Azacitidine 100mg/m2 D-2, -1, 1 Level 4 - Azacitidine 125mg/m2 D-2, -1, 1

Azacitidine at each level will be combined with the corresponding CHOP regimen as follows:

  • Cyclophosphamide 750mg/m2 d1
  • Doxorubicin 50 mg/m2 d1
  • Vincristine 1.4 mg/m2 (Max: 2 mg) d1
  • Prednisolone 100mg PO d1-5
  1. Phase II
  • Azacitidine determined dose daily for D-2, -1, 1, Cyclophosphamide 750mg/m2 d1, Doxorubicin 50 mg/m2 d1, Vincristine 1.4 mg/m2 (Max: 2 mg) d1, Prednisolone 100mg PO d1-5 (6 cycles in total)
  • Use prophylactic trimethoprim-sulfamethoxazole 1T from the day of study drug administration to 21 days after the last dose of study treatment
  • Administer Peg-GCSF on study d2.
  • After Cycle 2, the study treatment can be administered if the ANC has been restored to ≥1,500/μL and platelets to ≥75,000/μL, and non-hematological toxicities that occurred in the previous cycle, except alopecia, have resolved to Grade 1 or less on d1 of each cycle.
  • If these hematological and non-hematological toxicities are not resolved, the clinical trial can be delayed for up to 21 days.
  1. Consolidation therapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 85 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO diagnostic criteria:
  • •Angioimmunoblastic T-cell lymphoma
  • •Follicular helper T-cell lymphoma
  • •Peripheral T-cell lymphoma with follicular helper T-cell type
  • •20 to 85 years of age at diagnosis
  • •ECOG performance status 0-2
  • •Cardiac function suitable for chemotherapy: LVEF ≥45% on echocardiography or MUGA
  • •Appropriate renal function: Serum Cr ≤2.0mg/dL or eGFR ≥ 30mL/min according to the Cockroft-Gault formula
  • •Appropriate hepatic function: ALT ≤2.5x upper limit of normal (ULN) (or ≤5x ULN in the presence of liver involvement), total bilirubin ≤2x ULN (or ≤3x ULN in the presence of liver involvement)
  • •Appropriate hematologic findings: absolute neutrophil count (ANC) ≥1,500/μL, platelets ≥100,000/μL (or ANC ≥500/μL and platelets ≥50,000/ μL in the presence of bone marrow involvement)
  • •Written informed consent to participate in the study
  • •Capable of following the study visit schedule and other requirements in the protocol
  • •For women of childbearing potential, a negative pregnancy test
  • •Women of childbearing potential must use an effective method of contraception (i.e., hormonal contraception, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study period and for 3 months afterward. Men are to use an effective method of contraception during the study period and for 3 months afterward.
  • •Life expectancy ≥90 days (3 months)
  • •Hepatitis B or C infection: Hepatitis B carriers and subjects with inactive hepatitis C infection (normal levels of aminotransferases) are eligible if they take prophylactic antiviral drugs

排除标准

  • •Other subtypes of non-Hodgkin's lymphoma
  • •History of chemotherapy for Hodgkin's or other non-Hodgkin's lymphoma in the last 5 years
  • •History of active cancer diagnosed within the last 3 years (with the exception of completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer)
  • •Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as entecavir or tenofovir)
  • •History of chronic hepatitis C (with the exception of HCV IgG positive with a negative HCV-RNA quantification)
  • •History of human immunodeficiency virus (HIV) infection
  • •Congestive heart failure (NYHA class ≥3)
  • •Acute coronary syndrome (new-onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months prior to study entry
  • •History of major neurological or psychiatric illness, including dementia or epilepsy
  • •Severe chronic obstructive pulmonary disease with hypoxemia
  • •Cerebrovascular disease within 3 months prior to study entry (including transient cerebral ischemia)
  • •Unresolved wounds, ulcers, or bone fractures
  • •Uncontrolled active infections (viral, bacterial, or fungal infections)
  • •Concurrent use of other experimental drugs under investigation
  • •Known hypersensitivity to the investigational drugs
  • •History of major surgery or serious trauma within 21 days prior to study treatment. Open biopsy within 7 days prior to study treatment
  • •Male subjects who had not undergone a vasectomy and have a partner who plans to become pregnant or are unable to use a medically acceptable method of contraception (partner's sterilization or intrauterine device placement, or barrier method combined with diaphragm or condom) during the subject's participation in the study
  • •Pregnant or breastfeeding women or women of childbearing potential and men who are not willing to use appropriate methods of contraception during the study
  • •Previously treated for T-cell lymphoma with immunotherapy or chemotherapy, except for short-term corticosteroids (for less than 8 days) prior to selection
  • •Prior radiotherapy, except for those localized to a single lymph node
  • •Central nervous system involvement
  • •Contraindication to any of the drugs included in the chemotherapy
  • •History of administration of doxorubicin at >200 mg/m²

研究组 & 干预措施

Arm ACHOP

Experimental
  1. Phase I Azacitidine D1-3 + CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone)
  • Level 1 - Azacitidine 50mg/m2 D-2, -1, 1
  • Level 2 - Azacitidine 75mg/m2 D-2, -1, 1
  • Level 3 - Azacitidine 100mg/m2 D-2, -1, 1
  • Level 4 - Azacitidine 125mg/m2 D-2, -1, 1
  1. Phase II
  • Azacitidine D-2, -1, 1 + CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone)
  • 6 cycles in total

干预措施: ACHOP (Drug)

结局指标

主要结局

complete response rate

时间窗: Up to 72 months

次要结局

  • overall survival(Up to 72 months.)
  • progression-free survival(Up to 72 months.)
  • overall response rate(Up to 72 months)
  • event-free survival(Up to 72 months.)
  • Adverse events(from the day 1 of the clinical trial to 28 days after last drug administration)

研究者

发起方
Won Seog Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Won Seog Kim

Principal Investigator

Samsung Medical Center

研究点 (1)

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