Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 14
- 主要终点
- disease control rate
研究概览
简要总结
The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed T or NK cell lymphoma at the enrolling institution. For CTCL, patients with stage IB disease or greater are eligible.
- •Relapse or refractory disease after at least 1 systemic therapy except for T-PLL, LGL, or T-cell Lymphoproliferative diseases with JAK2 fusion.
- •Untreated patients may be allowed after discussion with P.I.
- •Measurable disease defined by:
- •Lugano Classification for systemic lymphoma or
- •Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood or bone marrow or
- •mSWAT > 0 or Sezary count ≥ 1000 cells/μL for CTCL
- •Previous systemic anti-cancer therapy for T-cell lymphoma must have been discontinued at least 2 weeks prior to treatment.
- •Glucocorticoids aimed at controlling lymphoma-related symptoms are allowed as long as they are tapered down to 20mg or less by the time of ruxolitiib initiation
- •Topical steroids for CTCL are permitted
- •See section 6.2 Subject
排除标准
- •for guideline regarding adjuvant and maintenance therapy for prior malignancy
- •Patients must meet the following lab criteria:
- •ANC ≥ 1.0/mm^3 or ANC >/= 0.5/mm^3 (if patient has baseline neutropenia due to lymphoma), platelets ≥ 100 x 10^9/L or ≥ 50 x 10^9/L (if related to lymphoma), Hgb ≥ 8g/dL
- •Patients with LGL or T-PLL are not required to meet a minimum ANC or hemoglobin value for eligibility
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or; ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's ; AST and ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma involvement
- •Creatinine clearance ≥ 30 mL/min; creatinine clearance of 15-29 mL/min will be allowed as long as baseline platelets are ≥ 150 x 10^9/L
- •For patients with positive hepatitis B core antibody or surface antigen, hepatitis B PCR must be negative and prophylaxis with entecavir or equivalent is required.
- •Patients with HIV are allowed provided that they are on anti-retroviral treatment with no active infections.
- •Exclusion Criteria:
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •ECOG performance status >2
- •Prior therapy with ruxolitinib
- •Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma)
- •Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator
- •Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal Investigator
- •Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test.
- •A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
研究组 & 干预措施
rel/ref PTCLtumors are known to contain mutations associ
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
干预措施: Ruxolitinib (Drug)
with rel/ref PTCL who do not meet criteria for cohort 1 or 2.
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
干预措施: Ruxolitinib (Drug)
with rel/ref PTCL with functional evidence of JAK/STAT
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
干预措施: Ruxolitinib (Drug)
Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
disease control rate
时间窗: 2 years
defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold.
次要结局
未报告次要终点