NCT02071901已完成2 期
A Single Arm, Phase II Study of Eltrombopag to Enhance Platelet Count Recovery in Elderly Patients With Acute Myeloid Leukemia Undergoing Remission Induction Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants With a Median Platelet Count >= 50,000/uL
研究概览
简要总结
This phase II trial studies how well eltrombopag olamine works in improving the recovery of platelet counts in older patients with Acute Myeloid Leukemia (AML) undergoing induction (the first treatment given for a disease) chemotherapy. Platelet counts recover more slowly in older patients, leading to risk of complications and the delay of post-remission therapy. Eltrombopag olamine may cause the body to make platelets after chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I.To determine whether eltrombopag leads to early platelet recovery in older AML patients (≥ 60years) who attain morphologic remission on day 14 (range, day 14-17) bone marrow assessment following remission induction chemotherapy (IC).
SECONDARY OBJECTIVES:
I. To determine the effect of eltrombopag on megakaryopoiesis - median time to reach platelet count ≥50,000 /μL and ≥100,000 /μL, number of days of platelet transfusion, rates of platelet transfusion-independence and the median time to reach platelet transfusion independence.
II. To determine the effect of eltrombopag on the rates of clinically significant bleeding events (CSBE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All categories of AML will be included except for acute promyelocytic leukemia (APL), acute megakaryocytic leukemia, and acute leukemias of ambiguous lineage undergoing 7 + 3 remission IC with cytarabine and an anthracycline (daunorubicin or idarubicin). All cases have to be histopathologically confirmed by a diagnostic bone marrow biopsy. Use of granulocyte colony-stimulating factor (G-CSF) for any indication must have been discontinued at least 7 days prior to entry into the study.
- •Patients with secondary AML arising out of Myelodysplastic syndrome (MDS) (all subtypes under WHO [World Health Organization] classification), chronic myelomonocytic leukemia (CMML); therapy-related AML and those with a prior autologous hematopoietic cell transplantation are eligible.
- •No morphological evidence of disease on day 14 bone marrow examination following IC
- •Must be able to give voluntary informed written consent to participate in the study; informed consent will be obtained prior to initiation of remission IC and before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below:
- •Females of childbearing potential: Recommendation is for 2 effective contraceptive methods during the study. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation.
- •Male patients with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study or to abstain.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent
- •Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the past 12 months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer).
- •Secondary AML arising out of myeloproliferative neoplasms [as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias] and MDS/myeloproliferative disease (MPD) neoplasms other than CMML [as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias]. Refractory Anemia with Ringed Sideroblasts with thrombocytosis (RARS-T) classified as MDS/MPN neoplasm, unclassifiable will be excluded. AML patients with presenting features suspicious of underlying unrecognized MPD such as marked splenomegaly (> 20 cm) and thrombocytosis (>400,000 per microliter) will be excluded. Patients with relapsed or refractory AML will be excluded.
- •Radiation therapy, cytotoxic chemotherapy, and combined modality (both radiation and chemotherapy) used to treat other cancers or medical conditions and administered within 12 months prior to signing informed consent. Use of hydroxyurea or emergent leukapheresis (for cytoreduction of highly elevated white blood cell counts) is permissible. Those AML patients who initially receive treatment with all-trans retinoic acid (ATRA) for presumptive diagnosis of APL but if APL is ruled out in final pathology will be eligible for the study.
- •Prior history of treatment with recombinant thrombopoietin (TPO) or TPO-receptor (R) agonists
- •History of arterial or venous thrombosis [excluding line-thrombosis] within the last 1 year, or those with known inherited coagulopathies. Arterial or venous thrombosis includes pulmonary embolism, deep vein thrombosis of both upper [excluding line-thrombosis] and lower extremities, coronary artery disease managed medically or requiring intervention (percutaneous stent placement or coronary bypass surgery), cerebrovascular accident (for transient ischemic attacks clinical documentation is required), or involvement of other organs (such as hepatic, renal, spleen or other sites).
- •Evidence of fibrosis on bone marrow examination at the time of diagnosis
- •Active participation in any other investigational treatment study
- •Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, unstable angina or renal insufficiency (acute or chronic) on hemodialysis
- •Liver enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) can not be greater than or equal to 2.5 times the upper limits of normal (ULN)
- •Total bilirubin ≥ 1.5 x ULN within 14 days of enrollment.
- •Serum creatinine should be ≥ 2.5 x ULN within 14 days of enrollment
- •A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol)
- •Known history of human immunodeficiency virus (HIV) or active hepatitis B or C
- •No major surgery within 2 weeks prior to trial enrollment
- •Female subject is pregnant or breast-feeding
- •Male and female patients who are fertile who do not agree to use an effective barrier methods of birth control (i.e. abstinence) to avoid pregnancy while receiving study treatment.
研究组 & 干预措施
Supportive care (eltrombopag olamine)
Experimental
Patients receive eltrombopag olamine by mouth (PO) daily (QD) until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
干预措施: eltrombopag olamine (Drug)
结局指标
主要结局
Number of Participants With a Median Platelet Count >= 50,000/uL
时间窗: Day 24 of Treatment
Number of participants with a median platelet count \>= 50,000/uL
次要结局
- Rates of Clinically Significant Bleeding Events(Up to 12 weeks)
- Complete Response Rate(Up to 12 weeks)
- Median Days to Attain Complete Response(Up to 12 weeks)
- Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days(up to 12 weeks)
- Median Time to Absolute Neutrophil Recovery, Defined as > 500/uL(Up to 12 weeks)
- Median Rise in Hemoglobin Level in Patients With Pretreatment Hemoglobin of < 8 g/dL(Up to 12 weeks)
- Partial Complete Response Rate(Up to 12 weeks)
- Rate of Refractory or Persistent Disease(Up to 12 weeks)
- Overall Survival (OS) - Percent of Participants Alive at Follow-up(at 28 days, at 6 months and up to 5 years)
- Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0(Up to 4 weeks after last dose of eltrombopag olamine)
- Disease-Free Survival(At 5 year follow-up)
- Median Days of Platelet Transfusions(Up to 12 weeks)
- Time to Initiation of Post-remission Therapy(Up to 12 weeks)
- Overall Survival (OS) - Percent of Participants Alive at Follow-up(at 28 days, at 6 months and up to 52 months)
- Disease-Free Survival(Up to 52 months)
- Overall Survival (OS) - Percent of Participants Alive at Follow-up(at 28 days, at 6 months)
研究者
研究点 (1)
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