CTIS2022-500721-32-01招募中1 期
A phase II study evaluating the efficacy and safety of IMetelstat in Patients with HR myElodysplastic SyndromeS or AML failing HMA-based therapy. - IMpress_001
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
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 65+（—）
- 性别
- All
入选标准
- •1. Signed written informed consent, 3. Must be able to adhere to the study visit schedule and other protocol requirements, 4. Initial diagnosis of AML or MDS according to WHO 2016 classification, 5. At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin < 10 g/dL), 6. a. Failure to achieve complete or partial response or hematological improvement observed after at least six azacitidine monotherapy or four decitabine monotherapy based 4-week treatment cycles administered during the past two years OR b. Failure to achieve complete or partial response or hematological improvement observed after at least two 4-week treatment cycles with azacitidine plus venetoclax or with decitabine plus venetoclax during the past two years OR c. Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) based 4-week treatment cycles administered during the past two years OR d. Relapse after initial complete or partial response or hematological improvement observed after at least two 4-week treatment cycles with azacitidine plus venetoclax or with decitabine plus venetoclax during the past two years OR e. Intolerance to treatment with HMA-based therapy during the past two years, 7. Not eligible for allogeneic stem cell transplantation, 8. = 5% bone marrow blasts at screening, 9. Off all other treatments for AML/MDS for at least 14 days; G-CSF and erythropoietin are allowed before and during the study as clinically indicated, 17. Patients who are relapsed or refractory to, or not eligible for, therapy with approved and available FLT3 or IDH1/IDH2 inhibitors or other approved targeted therapies., 10. ECOG performance status of 0-2, 11. Biochemical laboratory test values must be within the following limits: a. AST, ALT and ALP =2.5 times the upper limit of normal (x ULN) b. Serum creatinine =2.0 x ULN c. Total bilirubin =3 x ULN and direct bilirubin =2 x ULN (unless due to Gilbert’s syndrome, ineffective erythropoiesis due to MDS, or hemolysis due to RBC transfusion), 12. Availability of blood counts and transfusion events for previous 16 weeks, 13. Women of childbearing potential and practicing a highly effective method of birth control according to the Clinical Trial Facilitation Coordination Group Recommendation (Version 1.1, 2020)28: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal - progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable - intrauterine device (IUD) - intrauterine hormone-releasing system ( IUS) - bilateral tubal occlusion - vasectomised partner - sexual abstinence For females, these restrictions apply for 3 months after the end of dosing. Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described above, 14. A woman of childbearing potential must have a negative serum (?-human chorionic gonadotropin [?-hCG] pregnancy test at screening and agree to be tested (serum or urine) on day 1 of every cycle and at EOT, 15. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermic
排除标准
- •Chemotherapy within the 14 days prior to the first dose of imetelstat being administered (other than hydroxyurea), Major surgery within 4 weeks prior to day 1 of C1 (excluding the placement of vascular access and other minor surgical procedures), Diagnosed or treated for malignancy other than MDS or AML, except: a. Malignancy treated with curative intent and with no known active disease present for 3 years before day 1 of C1 b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated cervical carcinoma in situ without evidence of disease, Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of day 1 of C1, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification, Known history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection requiring IV antibiotics, Subject is in custody by order of an authority or a court of law, Previous assignment to treatment during this study, Close affiliation with the investigator (e.g., a close relative) or persons working at the study site, Subject is an employee of the sponsor or involved CRO, Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety, Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), or known acute or chronic liver disease including cirrhosis, Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the imetelstat metabolism, or put the study outcomes at undue risk; Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments, Females who are pregnant or are currently breastfeeding or planning to become pregnant while enrolled in this study or within 3 months after the end of dosing, Subject is a man who plans to father a child while enrolled in this study or within 3 months after the end of dosing, Subject has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients (refer to the IB), Subject has received an experimental or investigational drug or used an invasive investigational medical device within 30 days prior to day 1 of C1, Prior treatment with imetelstat, Prior history of intensive chemotherapy or hematopoietic stem cell transplant
研究者
相似试验
进行中（未招募）
不适用
A phase II study evaluating the efficacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients after progression of chemotherapy or hormonal treatment in combination with lapatinib for metastatic diseasemetastatic breast cancerEUCTR2009-016826-15-ATCECOG30
进行中（未招募）
1 期
A phase II study evaluating the efficacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients pretreated with chemotherapy or hormonal treatment in combination with lapatinib for metastatic diseasemetastatic breast cancerEUCTR2009-016826-15-CZCECOG30
进行中（未招募）
1 期
A phase II study evaluating the efficacy and safety of IMetelstat in Patients with HR myElodysplastic SyndromeS or AML failing HMA-based therapy.CTIS2022-500721-32-00Gcp-Service International West GmbH46
进行中（未招募）
不适用
A phase II study evaluating the efficacy and safety of the farnesyltransferase inhibitor ZARNESTRA® (R115777, tipifarnib) in patients with relapsed , refractory or progressive mantle cell lymphoma not appropriate for autologous bone marrow transplantation - Zarnestra® (tipifarnib) for oral administratioadult patients with relapsed , refractory or progressive mantle cell lymphoma not appropriate for autologous bone marrow transplantationMedDRA version: 9.1Level: LLTClassification code 10026800Term: Mantle cell lymphoma recurrentMedDRA version: 9.1Level: LLTClassification code 10026801Term: Mantle cell lymphoma refractoryEUCTR2006-007066-11-FRGELA
尚未招募
不适用
A phase II study evaluating the efficacy and safety of conversion surgery after intraperitoneal paclitaxel in combination with systemic capecitabine and oxaliplatin chemotherapy in advanced gastric cancer patients diagnosed with peritoneal disseminatioNeoplasmsKCT0005750Yonsei University Health System, Gangnam Severance Hospital43