Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

Официальное название

Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

Обзор

This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)

Подробное описание

This is a randomized, multi-center, open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP (L-CHOP) administered in 3 week cycles for 6 cycles. In the L-CHOP arm, Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary with drawl. Adverse event of every treatment cycle will be recorded. Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 3 years from the last patient randomized.

Вмешательства

• Препарат Lenalidomide
  25mg po on day 1-10
• Препарат Cyclophosphamide
  750mg/m² iv on day1
• Препарат Doxorubicin
  50mg/m² iv on day 1
• Препарат Vincristine
  1.4mg/m² iv on day 1
• Препарат Prednisone
  100mg po on day1-5

Первичные конечные точки

• Objective Response rate [Срок оценки: At the end of Cycle 6 (each cycle is 21 days)]

Вторичные конечные точки (3)

• Progression Free Survival [Срок оценки: 3 years]
• Overall Survival [Срок оценки: 3 years]
• Adverse Events [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with T-follicular helper phenotype and Follicular T-cell lymphoma).
• Males and females of 18 years of age to 80 years of age.
• Patients have not received anti-tumor therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
• Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.
• Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10\^9/L, hemoglobin(Hb)≥90g/L, platelet(PLT)≥100×10\^12/L.
• None of other serious disease conflict with the therapeutic regimen.
• None of other malignant tumor.
• Pregnancy test of women at reproductive age must be negative.
• Estimated survival time ≥ 3 months with good compliance.
• Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.

Критерии исключения

• Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
• Transformed lymphoma.
• Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
• Already initiated lymphoma therapy (except for the prephase treatment specified for this study).
• Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
• Patients who have central nervous system or meninges involvements.
• Candidate for hematopoietic stem cell transplantation.
• Known hypersensitivity to medications to be used.
• Hemogram abnormality: ANC<1.5×10\^9/L; or hemoglobin<90 g/L; or PLT<100×10\^9/L.
• Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
• Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months.
• Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
• Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity.
• Pregnancy or lactation period.
• Patients who participated in other clinical trials within 3 months.
• The researchers considered that patients should not be in this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT04922567 · IR2020002513

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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