A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years - HOVON 103 AML Lenalidomide

HOVO0 个研究点目标入组 168 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•· Patients eligible for standard chemotherapy.
•· Patients >= 66 years with a cytopathologically confirmed diagnosis according WHO
•classification of
•o AML (not APL) or
•o refractory anemia with excess of blasts (RAEB) with
•an IPSS score >= 1.5
•Patients of any age >= 18 years with a cytopathologically confirmed diagnosis
•according WHO classification of
•o AML with very poor risk AML
•· Subjects with secondary AML progressing from antecedent (at least 4 months
•duration) myelodysplasia are also eligible.
•· SGOT (AST) and SGPT (ALT) <= 1.5 x the upper limit of the normal range (ULN) at
•the laboratory where the analyses were performed.
•· Total serum bilirubin level <= 1.5 x the ULN at the laboratory where the analysis
•was performed.
•· Serum creatinine concentration <= 1.5 x the ULN at the laboratory where the
•analysis was performed.
•· WHO performance status <= 2
•· Written informed consent.
•· Female patients of childbearing potential must have a negative serum pregnancy
•test within 2 weeks prior to enrollment.
•· Male and female patients must use an effective contraceptive method during the
•study and for a minimum of 6 months after study treatment.(see protocol
•appendix J for more information and specific requirements)

•· Acute promyelocytic leukemia
•· Patients previously treated for AML (any antileukemic therapy including
•investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is
•· Past or current history (within the last 2 years prior to randomization) of
•malignancies except for the indication under this study and curatively treated:
•* Basal and squamous cell carcinoma of the skin
•* in situ carcinoma of the cervix
•· Blast crisis of chronic myeloid leukemia
•· Clinically significant (i.e. active) cardiovascular disease, for example
•cerebrovascular accidents (<= 6 months prior to randomization), myocardial
•infarction (<= 6 months prior to randomization), unstable angina, New York Heart
•Association (NYHA) grade II or greater congestive heart failure
•· Patients with a history of non-compliance to medical regimens or who are
•considered unreliable with respect to compliance
•· Patients with any serious concomitant medical condition which could, in the
•opinion of the investigator, compromise participation in the study.
•· Patients who have senile dementia, mental impairment or any other psychiatric
•disorder that prohibits the patient from understanding and giving informed
•· Pregnant or lactating patients.
•· Current concomitant chemotherapy, radiation therapy, or immunotherapy other
•than as specified in the protocol.

发起方

HOVO