NL-OMON52700招募中不适用
A Phase 1 trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies. - EDO-S101-1001 study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
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
- •1. Patient willing and able to sign an informed consent.
- •2. Patients age >=18 years at signing the informed consent.
- •3. Life expectancy > 3 months.
- •4. Diagnosis of relapsed or refractory lymphoid malignancy for which there are
- •no available therapies.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status <=2.
- •6. Absolute neutrophil count (ANC) (polymorphonuclear [PMN] cells plus
- •bands) >1,000 / µL.
- •7. Platelets >= 100,000 / µL.Platelet transfusions within the 14 days before Day
- •1 of Cycle 1 is prohibited.
- •8. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 x ULN.
- •9. Total bilirubin <2.0 mg/dL unless elevated due to known Gilbert's syndrome.
- •10. Renal function: estimated creatinine clearance by Cockroft-Gault
- •formula >= 45 mL/min.
- •11. Serum potassium and magnesium at least at the lowest limit of normal (LLN)
- •range, before every IMP administration; if it is below LNN, supplementation is
- •permissible.
- •12. Female study participants of childbearing potential, and their
- •partners, and male study participants who intend to be sexually active with a
- •woman of childbearing potential, must be willing to use at least TWO
- •highly effective forms of contraception. For female study participants,
- •this should start from the time of study enrollment and continue
- •throughout tinostamustine administration and for at least six months
- •after the last administration of IMP to be eligible to participate. For male
- •subjects who intend to be sexually active with a women of childbearing
- •potential they must use a condom during treatment and for at least 90
- •days after the last administration of IMP. Female study participants
- •should be willing to have a pregnancy test performed at screening, <= 1
- •day prior to day 1 of each IMP administration and at study treatment
- •discontinuation. Vasectomized males are considered fertile; therefore,
- •vasectomized partners and patients must be willing to use a secondary
- •method of effective birth control. Sexual abstinence is considered a
- •highly effective method only if defined as refraining from heterosexual
- •intercourse during the entire period of risk associated with the study
- •treatment. The reliability of sexual abstinence needs to be evaluated in
- •relation to the duration of the clinical trial and the preferred and usual
- •lifestyle of the patient.
- •Apart from the above general inclusion criteria, there are some criteria that
- •are specific for each cohort, see details in the protocol.
排除标准
- •1. Patients with any central nervous system (CNS) involvement.
- •2. Patient who had a hematologic malignancy that has transformed.
- •3. Patients who have relapsed within 100 days of stem cell infusion following an
- •autologous or allogeneic bone marrow transplant.
- •4. Patients with QTc interval (Fridericia*s formula) > 450 msec.
- •5. Patients who are on treatment with drugs known to prolong the
- •QT/QTc interval. Refer to CredibleMeds list of drugs with known risk of
- •Torsade de pointes (TdP): http://crediblemeds.org
- •6. Any serious medical condition that interferes with adherence to
- •study procedures.
- •7. Patients with a history of an other malignancy diagnosed within
- •three (3) years prior to study enrollment excluding basal cell carcinoma
- •of the skin, squamous cell carcinoma of the skin, or in situ cervical
- •cancer that has undergone potentially curative therapy.
- •8. Pregnant or breast feeding females.
- •9. New York Heart Association (NYHA) stage III/IV congestive heart
- •failure. The following arrhythmias: atrial fibrillation/flutter with poor rate
- •control, documented sustained ventricular tachycardia (defined as >30 seconds
- •or requiring cardioversion before 30 seconds have elapsed) or Torsades de
- •10. active infections, or other significant co-morbidities [e.g. active
- •central nervous system metastases and/or carcinomatous meningitis,
- •active infection requiring systemic therapy, history of human
- •immunodeficiency virus (HIV) infection, or active Hepatitis B or Hepatitis
- •11. Use of other anti cancer therapies and investigational agents within 28
- •days prior to the first dose of tinostamustine. After 28 days, patients may be
- •enrolled if they have recovered form any related toxicities >= Grade 1 (except
- •12. Steroid treatment within seven days prior to trial treatment. Patients that
- •require intermittent use of bronchodilators, topical steroids or local
- •steroid injections will not be excluded from the trial. Patients who have
- •been stabilized to 10 mg orally (PO) once daily (QD) or less seven days
- •prior to tinostamustine administration are allowed.
- •13. Patients on Valproic Acid for any indication (epilepsy, mood disorder)
- •must be excluded from the trial.
研究者
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