EUCTR2020-003400-13-FR进行中（未招募）1 期
A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy with Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes - GFM- BST003
Groupe Francophone des Myélodysplasies (GFM)0 个研究点目标入组 40 人开始时间: 2020年11月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Documented diagnosis of MDS, according to World Health Organization (WHO) classification and assessed as higher risk MDS, prior to first line HMA treatment, according to the Revised International Prognostic Scoring System (IPSS-R) (IPSS-R overall score = 4.5)
- •2. Diagnosed AML according to the 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia: =20% blasts in peripheral blood or bone marrow
- •3. Adult =18 years of age
- •3. Failure/relapse following prior first-line AML or MDS treatment, defined as:
- •i.Relapse after initial complete or partial response or stable disease with HI, according to International Working Group (IWG) 2006 criteria following treatment with; azacitidine, decitabine.
- •ii.Failure to achieve complete or partial response or stable disease with HI according to International Working Group (IWG) 2006 criteria after at least 4 cycles of azacitidine or decitabine all within the last 1 year.
- •iii.MDS progression while on azacitidine/decitabine treatment irrespective of the number of cycles the patient has received.
- •i.Relapse after initial CR/CRi/CRh following treatment with; azacitidine, decitabine, LDAC, venetoclax+HMA, or venetoclax+LDAC
- •ii.Failure to achieve CR, CRh or CRi following at least 4 cycles of azacitidine or decitabine or 2 cycles of venetoclax+ HMA or Venetoclax+ LDAC all within the last 1 year.
- •iii.AML progression while on HMA, LDAC, or venetoclax+ HMA or Venetoclax+ LDAC irrespective of the number of cycles the patient has received.
- •5. The participant is not able to receive an allogeneic bone marrow transplantation (BMT) at the time of study enrolment (BMT may be an option once the patient completed the study).
- •6. Not eligible for intensive chemotherapy.
- •a.Age =75 years
- •b.Age =18 years with at least one of the following comorbidities:
- •i.Significant heart or lung comorbidities, as reflected by at least one of the following:
- •Left ventricular ejection fraction (LVEF) =50%
- •Lung diffusing capacity for carbon monoxide (DLCO) =65% of expected
- •Forced expiratory volume in 1 second (FEV1) =65% of expected
- •Chronic stable angina or congestive heart failure controlled with medication
- •ii.Other comorbidity that the Investigator judges as incompatible with intensive chemotherapy, which must be documented
- •7. Creatinine clearance (MDRD) equation or measured by 24 hours urine collection =45 mL/min
- •8. Liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5 times the upper limits of normal (ULN), unless attributed to leukemia (in AML patients)
- •9. Total bilirubin =3 XULN unless due to Gilbert disease
- •10. performance status = 2
- •11. Women of reproductive potential must have a negative serum pregnancy test within 48 hours of the first day of any BST-236 treatment course
- •12. Women of reproductive potential must use two forms of effective birth control methods
- •13. Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 3 months following the last dose of study drug
- •14. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
- •15. Patient must be able to adhere to the study visit schedule and other protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
排除标准
- •1. MDS or AML evolving from a pre-existing myeloproliferative neoplasm (MPN)
- •2. MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
- •3. Acute promyelocytic leukemia
- •4. Previous treatment for AML or MDS with drugs other than HMA or combinations of venetoclax with either HMA or LDAC
- •5. Previous allogeneic HSCT or solid organ transplantation
- •6.Participation in a previous clinical trial involving use of an investigational drug within 90 days or at least 5 half-lives of tested drug (whichever is shorter) of study day 1
- •7. Peripheral White Blood Cell (WBC) count >30,000 /?L in the 48 hours prior to first BST-236 dose administration. Hydroxyurea administration or leukapheresis is permitted to meet this criterion
- •8. Administration of HMA, LDAC or venetoclax within 14 days prior to Study Day 1
- •9. Previous treatment with cytarabine at a dose higher than 20 mg/m2/ d
- •10. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
- •11. Any medical or surgical condition, presence of laboratory abnormalities or psychiatric illness that may preclude safe and complete study participation based on the Investigator’s judgment
- •12. Diagnosis of malignant disease (other than AML) within the previous 12 months (excluding basal cell carcinoma of the skin without complications, in-situ” carcinoma, or other local malignancy excised or irradiated with a high probability of cure and not treated with systemic or topical chemotherapy)
- •13. Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to first BST-236 dose administration
- •14. History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine
- •15. Life expectancy shorter than 3 months attributed to any known medical condition other than AML/MDS
- •16. Known infection with Hepatitis B Virus (HBV) Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
- •17. In 12 leads ECG, QTc>480msec or history of QT prolongation or Torsades de pointes
研究者
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