NCT03601819终止1 期
Phase Ib, Open Label, Single Center Study of Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Rate of dose limiting toxicities (DLT)
研究概览
简要总结
This trial will determine the safety and tolerability of Pacritinib in patients with relapsed/refractory lymphoproliferative disorders.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of any of the following:
- •Relapsed/refractory cutaneous (stage IIb-IV by ISCL/EORTC staging criteria) or peripheral T-cell lymphoma with progression after the last line of therapy and refractory to/intolerant of or have a contraindication to all established therapies known to provide clinical benefit (including brentuximab vedotin for patients with anaplastic large cell lymphomas) OR
- •Chronic lymphocytic leukemia (CLL), splenic marginal zone lymphoma (SMZL), Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) or mantle cell lymphoma (MCL) with disease progression on ibrutinib or who discontinue ibrutinib due to toxicity/intolerance. In addition, patients should be refractory to/intolerant of or have a contraindication to all established therapies known to provide clinical benefit OR
- •Any lymphoproliferative disorder who have failed at least 2 prior therapies and are refractory to/intolerant of or have a contraindication to all established therapies known to provide clinical benefit and have had mutational analysis or sequencing studies performed in a CLIA certified laboratory demonstrating a mutation or gene fusion involving MyD88, JAK2, JAK3, TYK2, or IRAK1 that are known or suspected to be "activating" (gain-of-function).
- •Age ≥ 18 at time of enrollment
- •ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
- •Adequate organ and marrow function as defined in the protocol
- •Ability to take oral medication without crushing, dissolving or chewing tablets.
- •In the investigator's opinion, the patient requires immediate treatment.
- •Ability to understand and the willingness to sign a written informed consent.
- •In the investigator's opinion, the patient has the ability to communicate satisfactorily with the investigator and the study team, to participate fully in the study, and comply with all requirements.
排除标准
- •History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
- •Pregnant or breast feeding women
- •Unwilling or unable to use a medically acceptable form of contraception during the time of participation in the trial (sexual abstinence is permissible) unless documented successful vasectomy, hysterectomy, bilateral oophorectomy or post-menopausal for at least 2 years
- •Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class II, III or IV (Appendix II); unstable angina pectoris within 6 months of study enrollment; unstable cardiac arrhythmia; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
- •Known HIV infection
- •Known positive Hepatitis B surface antigen or Hep C virus
- •Recent (within 21 days of initiation of therapy, day 1) major surgery
- •Less than 14 days have elapsed since last radiation therapy or chemotherapy treatment or patient has not recovered from all clinically significant treatment-related toxicity; less than 90 days have passed since date of autologous stem cell transplant and patient has not recovered to ≤grade 1 toxicity related to this procedure
- •Use of systemic steroids (oral, inhaled, nasal, topical) at a dose less > 10 mg/day of prednisone
- •Prior treatment with pacritinib
- •Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP). Coombs positivity in absence of hemolysis is not an exclusion.
- •Requires anticoagulation with heparin, warfarin or equivalent Vit K antagonist
- •History of significant bleeding (≥Grade 2 by CTCAE) history or complications (including bleeding that may have occurred while on ibrutinib)
- •Hypersensitivity or allergic reaction to compounds related to pacritinib
- •Treatment with potent CYP450 inducers and strong CYP3A4 inhibitors for which no alternative is available; treatment with strong CYP450 inducers or strong CYP3A4 inhibitors within 2 weeks of initiation of therapy, day 1
- •Concurrent administration of QTc prolonging agents; significant QTc prolonging agents must be stopped within 5 half-lives of day
- •Any gastrointestinal or metabolic condition that could interfere with the absorption of oral medication
研究组 & 干预措施
Pacritinib
Experimental
200 mg twice daily (with possible dose reduction to 100 mg twice daily)
干预措施: Pacritinib (Drug)
结局指标
主要结局
Rate of dose limiting toxicities (DLT)
时间窗: At 28 days
Dose limiting toxicity (DLT) rate during the 1st cycle (28 days) of pacritinib.
次要结局
- Duration of response (DOR)(Up to 2 years)
- Time to next treatment(Up to 2 years)
- The proportion of patients that experience a complete response (CR)(Up to 2 years)
- The proportion of patients that respond to treatment(Up to 2 years)
研究者
研究点 (1)
Loading locations...
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