DRKS00023646招募中3 期
Prospective randomized multicenter phase III trial of decitabine and venetoclax administered in combination with all-trans retinoic acid or placebo in patients with acute myeloid leukemia who are ineligible for induction chemotherapy - DECIDER-2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Previously untreated AML (WHO 2016)
- •3. ECOG = 2
- •4. White blood cell count < 25 × 109/L (hydroxyurea or Ara-C are permitted to meet this criterion see section 6.6.2)
- •5. No standard induction chemotherapy feasible; the following criteria are generally accepted:
- •age = 75 years
- •ECOG = 1
- •HCT-CI = 3
- •patient declines standard aggressive chemotherapy
- •missing social support system
- •6. Projected life expectancy of at least 8 weeks
- •7. Written informed consent obtained according to international guidelines and local laws
- •8. Ability to understand the nature, significance and consequences of the trial and the trial related procedures and to comply with them
排除标准
- •1. Acute promyelocytic leukemia (APL, FAB M3)
- •2. Previous treatment with DAC, azacitidine, or other DNA-hypomethylating agents, ATRA, venetoclax and other Bcl-2 inhibitors
- •3. Previous allogeneic stem cell transplantation or solid organ transplantation
- •4. Previous induction chemotherapy
- •5. Previous low-dose chemotherapy (e.g. hydroxyurea, cytosine arabinoside (Ara-C), melphalan etc.) within 4 weeks prior to the first administration of study treatment, except for cytoreduction of leukocytosis = 25,000/µl with hydroxyurea or Ara-C as proscribed by the clinical trial protocol (section 6.6.2); the patient must have recovered from all clinically relevant reversible non-hematologic toxicities
- •6. Central nervous system (CNS) leukemia
- •7. Severe congestive heart failure or clinically unstable cardiac disease
- •8. Known positivity for HIV, Hepatitis B# or Hepatitis C
- •9. Uncontrolled bacterial, viral or fungal infection
- •10. Known allergy against soy-beans or peanuts (due to ATRA excipients)
- •11. Known hypersensitivity to or intolerance of one of the trial drugs or its constituents (e.g. other retinoids or sunset yellow FCF E110)
- •12. Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- •13. Any malignancy requiring chemotherapy for which the patient received chemotherapy within 3 months prior to randomization
- •14. Participation in any other interventional clinical trial within the last 30 days before randomization
- •15. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- •16. Patient without legal capacity
- •17. Known or persistent abuse of medication, drugs or alcohol
- •18. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic
- •19. Person who is in a relationship of dependence/employment with the sponsor or the investigator
- •20. Current or planned pregnancy, nursing period
- •21. For fertile patients: failure to use one of the following safe methods of contraception: intra-uterine device or hormonal contraception in combination with a mechanical method of contraception.
研究者
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