NL-OMON52523招募中2 期
A phase II study evaluating the effect of DA-EPOCH-R induction followed by nivolumab consolidation in patients with newly diagnosed high grade B cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements - HOVON 152 DLBC
HOVO0 个研究点目标入组 88 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •DA-EPOCH-R inclusion criteria:,
- •* High-grade B-cell lymphoma, with MYC in combination with BCL2 and/or BCL6
- •rearrangements as assessed by FISH according to the WHO 2016 classification
- •including high-grade-B-cell lymphoma with MYC and BCL2 rearrangements,
- •transformed from previously untreated FL.
- •* Age >= 18 year.
- •* Patient started with or has received one course of full dose R-CHOP or
- •DA-EPOCH-R (cycle 1). Starting with DA-EPOCH-R in cycle 1 is only allowed when
- •FISH results (confirming DH/TH diagnosis) are directly available at diagnosis.
- •[Reversed R-CHOP (cyclophosphamide, vincristine and doxorubicin on day 5) is
- •allowed; local radiation or short course (max 7 days) of steroids (max 100
- •mg/day) before R-CHOP is allowed. Mini-R-CHOP is not allowed].
- •* WHO performance status 0-3 during or after induction cycle 1 (see appendix C).
- •* Ann Arbor stage II-IV at diagnosis (see appendix A).
- •* 18F-FDG PET scan and contrast enhanced CT-scan performed preferably within 28
- •days before start first induction cycle. When the PET or CT-scan is performed
- •outside the 28-day window, consultation and written approval by the Principal
- •Investigator for potential patient inclusion are necessary.
- •* Measurable disease: on contrast enhanced CT-scan at least 1 lesion/node with
- •a long axis of >1.5 cm and at least one 18F-FDG avid lesion.
- •* Negative pregnancy test at study entry.
- •* Patient is willing and able to use adequate contraception until 6 months post
- •last treatment administration.
- •* Written informed consent.
- •* Patient is capable of giving informed consent.,
- •Inclusion criteria nivolumab: ,
- •* Complete metabolic response on end of induction 18F-FDG PET-CT assessed with
- •the Deauville response criteria (see 10.3) (or higher when due to inflammatory
- •response, only possible after written approval by the Principal Investigator).
- •* Patient has completed at least treatment of at least 5 induction cycles.
排除标准
- •DA-EPOCH-R exclusion criteria,
- •* All histopathological diagnoses other than DH/TH-HGBL (like testicular large
- •B-cell lymphoma or primary mediastinal B-cell lymphoma) according to WHO 2016
- •classification.
- •* Known history of indolent lymphoma previously treated with
- •immunochemotherapy.
- •* Inadequate renal function or creatinine clearance < 30 mL/min (after
- •rehydration).
- •* Inadequate hepatic function: bilirubin > 3 times ULN (total) except patients
- •with Gilbert's syndrome as defined by > 80% unconjugated bilirubin.
- •* Inadequate hematological function: ANC < 1.0x109/L or platelets < 75x109 /L
- •before induction cycle 1 unless lymphoma related.
- •* CNS localization of the lymphoma. CSF analysis before start of treatment is
- •only necessary in case of suspicion of CNS localization.
- •* Female subject pregnant or breast-feeding.
- •* History of active malignancy during the past 5 years with the exception of
- •basal carcinoma of the skin or stage 0 cervical carcinoma.
- •* Active symptomatic ischemic heart disease, myocardial infarction, or
- •congestive heart failure within the past year. In case of cardiac history, an
- •echo or MUGA should be obtained and LVEF should exceed 40% to be eligible.
- •* Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
- •diabetes, infection, hypertension, cancer, etc.) that would jeopardize the
- •patient's ability to receive the regimen with reasonable safety.
- •* HIV positivity.
- •* Active Hepatitis B or C infection as defined by positive serology and
- •transaminitis. Non-active Hepatitis B carriers may be included if protected
- •(see 9.2.3).
- •* Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D).
- •* Subjects with active, known or suspected autoimmune disease. Subjects with
- •vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
- •condition only requiring hormone replacement, psoriasis not requiring systemic
- •treatment, or conditions not expected to recur in the absence of an external
- •trigger are permitted to enroll.
- •* Subjects with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalents) or other
- •immunosuppressive medications within 14 days of study drug administration.
- •Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily
- •prednisone equivalents are permitted in the absence of active autoimmune
- •* Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, or anti-CTLA-4
- •antibody, or any other antibody or drug specifically targeting T-cell
- •costimulation or immune checkpoint pathways.
- •* Severe neurological or psychiatric disease.
- •* Current participation in another clinical trial interfering with this trial.
- •* Any psychological, familial, sociological and geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule.
- •* Claustrophobia precluding PET-CT., nivolumab exclusion criteria:, *
- •Inadequate renal function or creatinine clearance < 30 mL/min (after
- •rehydration). Creatinine clearance may be calculated by Cockcroft -Gault
- •CrCl = (140 - age [in years]) x weight [kg] (x 0.85 for females)
- •(0.815 x serum creatinine [µmol/L])
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