CTRI/2023/11/059758尚未招募2 期
A Phase 2a study of HT-6184 in subjects with IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia. - NI
Halia Therapeutics0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Subjects greater than or equal to 18 years of age
- •2. Subject has signed the Informed Consent Form (ICF) and is able to comply with scheduled visits, treatment schedule, laboratory tests, bone marrow aspirates collection, biopsy and other protocol requirements.
- •3. Adequate organ function as defined by the following laboratory values
- •a) Serum creatinine less than 2.0 X ULN
- •b) AST and ALT less than 3.0 X ULN
- •c) Total bilirubin less than 1.5 X ULN (or total bilirubin less than or equal to 3.0 x ULN with direct bilirubin within normal range only in subjects with well documented Gilberts syndrome or hemolysis or who required regular blood transfusions)
- •4. A documented diagnosis of MDS or non-proliferative (WBC less than 13,000 per micro L) myelodysplastic or myeloproliferative neoplasm (MDS or MPN) according to World Health Organization (WHO) 2022 classification and Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease (refer Appendix C)
- •Following MDS subjects as per WHO 2022 criteria are eligible (refer Appendix D)
- •MDS with low blasts and isolated 5q deletion (MDS-5q)
- •MDS with low blasts and SF3B1 mutation (MDS-SF3B1)
- •MDS with low blasts (MDS-LB)
- •MDS, hypoplastic (MDS-h)
- •MDS with increased blasts (MDS-IB) MDS-IB1
- •Following non-proliferative MDS or MPN subjects as per WHO 2022 criteria are eligible (refer Appendix E)
- •Chronic myelomonocytic leukaemia Myelodysplastic or myeloproliferative neoplasm with neutrophilia Myelodysplastic or myeloproliferative neoplasm with SF3B1 mutation and thrombocytosis Myelodysplastic or myeloproliferative neoplasm, not otherwise specified
- •5. Less than 10 percent bone marrow myeloblasts
- •6. Refractory or intolerant of, or ineligible for treatment with an erythroid stimulating agent (ESA) as defined by any of the following
- •a) Refractory to prior ESA treatment: Prior treatment with an ESA without response or no longer responding to an ESA alone or in combination with a myeloid growth factor (must have received recombinant erythropoietin (rHu EPO) with epoetin alfa greater than or equal to 40,000 IU per week for greater than 8 weeks or darbepoetin alpha 300-500 micro g Q 2-3 W for greater than 8 week
- •b) Intolerant to prior ESA treatment Intolerant to prior ESA treatment with documentation of discontinuation due to intolerance or adverse event.
- •c) ESA ineligible: Subject may be ESA ineligible due to low probability of response to ESAs based upon endogenous serum erythropoietin level greater than 200 U per L for subjects not previously treated with ESAs
- •7. Prior ESA treatment must have been discontinued greater than or equal to 2 weeks prior to date of study treatment
- •8. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. (refer appendix A)
- •9. Subjects must have symptomatic anemia with non-transfused hemoglobin less than 9.0 g per dL within 8 weeks of screening or red blood cell (RBC) transfusion-dependent defined as receiving greater than 3 units of PRBCs in the preceding 16 weeks of screening for a hemoglobin less than9.0g per dL.
- •10. NGS (Next-generation sequencing) myeloid specific somatic gene mutation profile where applicable with greater than or equal to 5 percent quantitation of clone size by variant allele frequency (VAF).
- •11. Women of child bearing potential, (defin
排除标准
- •1. Other causes of anemia such as iron deficiency. Subjects must have documented marrow iron stores or serum ferritin >50 ng/ml. If marrow iron store is not available, the transferrin saturation must be > 20% or a serum ferritin > 50 ng/ mL.
- •2. Clinically significant anemia resulting from B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding.
- •3. Women must not be pregnant or breastfeeding. Females of childbearing potential should have a negative pregnancy test (sensitivity of at least 50 mIU/mL) within 28 days of first dosing and negative urine pregnancy test on day 1 of cycle 1.
- •4. Presence of concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active
- •severe infection, uncontrolled hypertension, uncontrolled seizure, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia
- •5. Secondary MDS, defined as MDS that is known to have arisen as a result of chemical injury or treatment with chemotherapy and/or radiation for other diseases.
- •6. Treatment with cytotoxic chemotherapeutic agents or experimental agents for the treatment of MDS within 4 weeks of study treatment.
- •7. Chronic use of systemic corticosteroids for comorbid or study disease condition with in last 4 weeks of study treatment
- •8. Prior history of malignancy other than MDS (except non-melanoma skin cancer or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for > 3 years.
- •9. Subject has undergone a stem cell, bone marrow or solid organ transplant
- •10. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •11. Prior treatment with disease modifying agents such as hypomethylating agents, or immunosuppressive therapy or experimental agents other than growth factor for MDS.
- •12. Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •13. Loss of greater than or equal to 350 ml of blood within 90 days before the first dose of Investigational Product.
研究者
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