Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

Официальное название

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

Обзор

The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.

Вмешательства

• Препарат Lenalidomide
  Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle
• Препарат Rituximab
  Rituximab 375 mg/m2，IV, d0
• Препарат Etoposide
  Etoposide 50 mg/m2/day CI24h d1-d4
• Препарат Doxorubicin
  Doxorubicin 10 mg/m2/day CI24h d1-d4
• Препарат Vincristine
  Vincristine 0.4mg/m2/day CI24h d1-d4
• Препарат Cyclophosphamide
  Cyclophosphamide 750 mg/m2/day IV d5
• Препарат Prednisone
  Prednisone 60 mg/m2/bid oral or IV d1-d5

Первичные конечные точки

• maximum tolerated dose and dose limited toxicity [Срок оценки: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)]
• Overall response rate [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Progressive free survival [Срок оценки: 2 years]
• Overall survival [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.
• ECOG PS 0-2
• Age 18-60 years old
• Expected survival ≥ 12 weeks
• A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
• Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Критерии исключения

• Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
• Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
• Previous exposure to any anti-tumor therapy
• Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma
• History of DVT or PE within past 12 months
• Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
• New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
• CNS or meningeal involvement
• Known sensitivity or allergy to investigational product
• Major surgery within three weeks
• Patients receiving organ transplantation
• Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
• Presence of Grade III nervous toxicity within past two weeks
• Active and severe infectious diseases
• Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
• In any conditions which investigator considered ineligible for this study
• Patients with histological transformation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) — Нанкин

Публикации

• Godfrey JK, Nabhan C, Karrison T, Kline JP, Cohen KS, Bishop MR, Stadler WM, Karmali R, Venugopal P, Rapoport AP, Smith SM. Phase 1 study of lenalidomide plus dose-adjusted EPOCH-R in patients with aggressive B-cell lymphomas with deregulated MYC and BCL2. Cancer. 2019 Jun 1;125(11):1830-1836. doi: 10.1002/cncr.31877. Epub 2019 Feb 1. PMID 30707764
• Coiffier B, Sarkozy C. Diffuse large B-cell lymphoma: R-CHOP failure-what to do? Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):366-378. doi: 10.1182/asheducation-2016.1.366. PMID 27913503
• Dunleavy K, Fanale MA, Abramson JS, Noy A, Caimi PF, Pittaluga S, Parekh S, Lacasce A, Hayslip JW, Jagadeesh D, Nagpal S, Lechowicz MJ, Gaur R, Lucas A, Melani C, Roschewski M, Steinberg SM, Jaffe ES, Kahl B, Friedberg JW, Little RF, Bartlett NL, Wilson WH. Dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) in untreated aggressive diffuse large PMID 30501868

Идентификаторы

NCT: NCT04432714 · 2019-SR-430

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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