ISRCTN28039294已完成1 期
A Phase I dose escalation trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31183877 results (added 09/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 26/10/2017:
- •1. Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) AML (defined by WHO criteria) for which no further conventional therapy is suitable for the patient; or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration.
- •2. Peripheral white blood cell (WBC) count =20x109/L within 1 week of registration (Day -7 to Day 1). Patients with WBC >20x109/L can be treated with hydroxyurea (up to 4 g/day) throughout the trial to reduce the WBC to =20x109/L prior to each dose of IMP. The white count must also be measured on the day of the first dose and be =20x109/L. Oral etoposide (up to 200mg PO/ day) may be given as an alternative to hydroxyurea for patients who are intolerant to hydroxyurea or cannot achieve sufficient white count lowering on hydroxyurea.
- •3. Male or female, Age >= 18 years
- •4. ECOG performance score of 01
- •5. Willing and able to comply with the protocol for the duration of the study, and scheduled followup visits and examinations
- •6. Willing to undergo blood transfusions as deemed clinically necessary
- •7. Pretreatment blood cross match completed
- •8. Written (signed and dated) informed consent and be capable of cooperating with protocol
- •9. Biochemical indices within the ranges shown below:
- •9.1. AST/SGOT or ALT/SGPT = 3 x ULN
- •9.2. Alkaline phosphatase = 2 x ULN
- •9.3. Bilirubin = 2x ULN (except for patients with a known or suspected history of Gilbert’s Syndrome)
- •9.4. eGFR >35 mls/min (Cockcroft and Galton method)
- •Current inclusion criteria as of 02/08/2017:
- •1. Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) AML (defined by WHO criteria) for which no further conventional therapy is suitable for the patient; or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration.
- •2. Peripheral white blood cell (WBC) count =20x109/L within 1 week of registration (Day -7 to Day 1). Patients with WBC >20x109/L can be treated with hydroxyurea (up to 4 g/day) throughout the trial to reduce the WBC to =20x109/L prior to each dose of IMP. The white count must also be measured on the day of the first dose and be =20x109/L. Oral etoposide (up to 200mg PO/ day) may be given as an alternative to hydroxyurea for patients who are intolerant to hydroxyurea or cannot achieve sufficient white count lowering on hydroxyurea.
- •3. Male or female, Age >= 18 years
- •4. ECOG performance score of 01
- •5. Willing and able to comply with the protocol for the duration of the study, and scheduled followup visits and examinations
- •6. Willing to undergo blood transfusions as deemed clinically necessary
- •7. Pretreatment blood cross match completed
- •8. Written (signed and dated) informed consent and be capable of cooperating with protocol
- •9. Haematological and biochemical indices within the ranges shown below:
- •9.1. AST/SGOT or ALT/SGPT = 3 x ULN
- •9.2. Alkaline phosphatase = 2 x ULN
- •9.3. Bilirubin = 2x ULN (except for patients with a known or suspected history of Gilbert’s Syndrome)
- •9.4. eGFR >35 mls/min (Cockcroft and Galton meth
排除标准
- •Current exclusion criteria as of 26/10/2017:
- •1. Females: Pregnant or breastfeeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial
- •2. Any prior exposure to Hu5F9G4 or other CD47 targeting agent
- •3. Treatment with any other investigational agent within 28 days prior to enrolment
- •4. Prior cytotoxic chemotherapy (with the exception of hydroxycarbamide), immunotherapy, or radiotherapy within 4 weeks prior to Day 1
- •5. Acute Promyelocytic Leukaemia
- •6. Patients with known inherited or acquired bleeding disorders
- •7. Previous allogeneic haematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant-related immunosuppression
- •8. Evidence for active CNS involvement by leukaemia
- •9. Clinical evidence or known history of cardiopulmonary disease defined as follows:
- •9.1. Acute myocardial infarction within the last 12 months
- •9.2. Requirement for treatment of angina or existence of unstable angina
- •9.3. Congestive heart failure NYHA Class II–IV
- •9.4. Uncontrolled hypertension despite adequate treatmen
- •10. Symptomatic intrinsic lung disease (chronic obstructive pulmonary disease, pulmonary fibrosis)
- •11. Other psychological, social or medical condition (e.g. active severe sepsis) physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
- •12. Any other malignancy within the previous 24 months, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
- •13. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
- •Current exclusion criteria as of 02/08/2017:
- •1. Females: Pregnant or breastfeeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial
- •2. Any prior exposure to Hu5F9G4 or other CD47 targeting agent
- •3. Treatment with any other investigational agent within 28 days prior to enrolment
- •4. Prior cytotoxic chemotherapy (with the exception of hydroxycarbamide), immunotherapy, or radiotherapy within 4 weeks prior to Day 1
- •5. Acute Promyelocytic Leukaemia
- •6. Patients with known inherited or acquired bleeding disorders
- •7. Previous allogeneic haematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant-related immunosuppression
- •8. Evidence for active CNS involvement by leukaemia
- •9. Clinical evidence or known history of cardiopulmonary disease defined as follows:
- •9.1. Acute myocardial infarction within the last 12 months
- •9.2. Requirement for treatment of angina or existence of unstable angina
- •9.3. Congestive heart failure NYHA Class II–IV
- •9.4. Uncontrolled hypertension despite adequate treatment (sustained systolic BP > 150 or diastolic BP > 100)
- •10. Symptomatic intrinsic lung disease (chronic obstructive pulmonary disease, pulmonary fibrosis)
- •11. Other psychological, social or medical condition (e.g. active severe sepsis) physical examination finding or a laboratory abnormality that the Invest
研究者
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