JPRN-jRCT2080223907已完成1 期
A Phase 1 Clinical Study of DSP-2033 (Alvocidib) in Combination with Cytarabine/Mitoxantrone or Cytarabine/Daunorubicin (7+3) in Patients with Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
ACM regimen part ACM regimen (Cohort R2: DSP-2033, 30 mg/60 mg; DSP-AraC, 667 mg/m2/day; DSP-MIT, 40 mg/m2/day) was considered to be tolerable in Japanese patients with relapsed/refractory AML. A+7+3 regimen part A+7+3 regimen (DSP-2033, 30 mg/60 mg; cytarabine, 100 mg/m2/day; DSP-DNR, 60 mg/m2/day) was considered to be tolerable in Japanese patients with newly diagnosed AML.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •[For all parts]
- •1. Japanese patients diagnosed with AML by the 4th edition of WHO criteria.
- •2. Patients aged between 20 and 64 at acquisition of informed consent.
- •3. Have received an adequate explanation of the objectives/contents of the clinical study, anticipated therapeutic effects/pharmacology, and risks to his/her understanding, and voluntarily provide written informed consent to participation in the clinical study.
- •4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2 at entry.
- •5. Have a left ventricular ejection fraction (LVEF) greater than or equal to 50% determined by echocardiography or multigated acquisition (MUGA) scan within 14 days prior to entry.
- •6. Have an arterial oxygen saturation (SpO2) greater than or equal to 90% within 14 days prior to entry.
- •7. The laboratory test within 14 days prior to entry (for multiple tests, the most recent before the entry) meet the following criteria for major organ function.
- •a. Serum creatinine less than or equal to 1.5 x the upper limit of normal (ULN) of the institutional reference
- •b. AST and ALT less than or equal to 2 x ULN of the institutional reference standard
- •c. Total bilirubin less than or equal to 2.0 mg/dL
- •8. Female patients of childbearing potential must have negative pregnancy test results at entry.
- •9. Female patients or patients with partners of childbearing potential must agree to use an appropriate method of contraception for a period between acquisition of informed consent and 6 months (180 days) after the final dose so that patients or female partners would not become pregnant.
- •[ACM regimen part]
- •In addition to the inclusion criteria for all parts, patients must meet the following criterion.
- •10. AML patients who could not attain remission after 1 or 2 cycles of potent chemotherapy with anthracycline, cytarabine, and etoposide, or potent chemotherapy with anthracycline and cytarabine. Or patients with 1st or 2nd recurrent AML after complete remission following initial therapy.
- •[A+7+3 regimen part]
- •In addition to the inclusion criteria for all parts, patients must meet the following criterion
- •11. Treatment naive AML patients.
排除标准
- •Exclusion Criteria:
- •[For all parts]
- •1. Diagnosed with acute promyelocytic leukemia (APL) (FAB classification: M3).
- •2. Received a transplantation such as hematopoietic stem cell transplant.
- •3. Have active central nervous system (CNS) leukemia.
- •4. Complicated by greater than or equal to Grade 3 infection as specified in Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).
- •5. HIV antibody, HBs antigen, or HCV antibody tested positive within 90 days prior to entry. (If HCV-RNA quantification is negative, even patients with positive HCV antibody may be enrolled in this study after discussion with the sponsor.)
- •6. Have New York Heart Association (NYHA) cardiac function classification III or IV heart disease or a history, greater than or equal to Grade 3 arrhythmia, angina pectoris or abnormal electrocardiogram (ECG) findings as specified in CTCAE v4.03 or a history of these above.
- •7. Have a disease that may interfere with the study treatment, such as interstitial pneumonia, pulmonary fibrosis, or active tuberculosis.
- •8. Complicated by uncontrolled disseminated intravascular coagulation.
- •9. Have other active malignancies (synchronous multiple malignancies and metachronous multiple malignancies with a disease-free interval not more than 5 years. However, carcinoma in situ that is determined to be cured by local treatment or lesions equivalent to mucosal carcinoma are not included in active multiple malignancies.)
- •10. Have an uncontrolled complication.
- •11. Complicated by mental deficits or have a history of mental deficits. However, patients who are able to comply with the study protocol can be included at the discretion of a physician.
- •12. Complicated by varicella.
- •13. Received any previous treatment with DSP-2033 or other CDK inhibitors.
- •14. Received any investigational product or post-marketing clinical study drug within 3 months (90 days) prior to entry.
- •15. Pregnant or lactating women*)
- •*) If a lactating woman agrees to discontinue breast feeding between acquisition of informed consent and 6 months (180 days) after the final dose, she could be included in the study.
- •16. Patients who are determined to be inappropriate for participation in this study by the investigator or subinvestigator.
- •[ACM regimen part]
- •In addition to the exclusion criteria cfor all parts, patients who meet any one of the following criteria 17 to 21 will be excluded from the ACM regimen part.
- •17. Have the cumulative total exposure of anthracycline, daunorubicin-equivalent dose, exceeds 360 mg/m2 (body surface area) at entry.
- •18. Received other leukemia treatment within 21 days prior to entry.
- •19. Have a history of radiation therapy on the mediastinum.
- •20. Have sustained greater than or equal to Grade 2 adverse drug reaction (except alopecia) as specified in CTCAE v4.03, which developed by the previous treatment.
- •21. Have a history of hypersensitivity against any one of cytarabine, mitoxantrone, or contained excipients.
- •[A+7+3 regimen part]
- •In addition to the exclusion criteria for all parts, patients who meet any one of the following criteria 22 to 23 will be excluded from the A+7+3 regimen part.
- •22. Have the cumulative total exposure of anthracycline, daunorubicin-equivalent dose, exceeds 100 mg/m2 (body surface area) at entry.
- •23. Have a history of hypersensitivity against any one of cytarabine, daunorubicin, or contained excipients.
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