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A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

Status: Recruiting
Phase:
Diagnosis: Leukemia/MDS
NCT ID: NCT02421939 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 16-034

 

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in patients with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival compared to salvage chemotherapy. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Amir Fathi, M.D., Massachusetts General Hospital

Site-responsible Investigators:
Richard Stone, MD, Dana-Farber Cancer Institute
Malgorzata McMasters, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification (2008) as determined by pathology review at the treating institute. - Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant (HSCT)). - Refractory to first-line AML therapy is defined as: 1. Subject did not achieve complete remission/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp) under initial therapy. A subject eligible for standard therapy must receive at least one cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least one complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject. - Untreated first hematologic relapse is defined as: 1. Subject must have achieved a CR/CRi/CRp (criteria as defined by [Cheson et al, 2003], see Section 5.3) with first line treatment and has hematologic relapse. - Subject is positive for FMS-like tyrosine kinase (FLT3) activating mutation in bone marrow or whole blood as determined by central lab. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. - Subject is eligible for pre-selected salvage chemotherapy. - Subject must meet the following criteria as indicated on the clinical laboratory tests: - Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) - Serum total bilirubin ≤ 1.5 x ULN - Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as calculated by the Modification of Diet in Renal Disease equation. - Subject is suitable for oral administration of study drug. - Female subject must either: - Be of non-child bearing potential: 1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or 2. documented surgically sterile (at least 1 month prior to Screening) - Or, if of childbearing potential, 1. Agree not to try to become pregnant during the study and for 45 days after the final study administration 2. And have a negative urine pregnancy test at Screening 3. And, if heterosexually active, agree to consistently use two forms of effective contraception per locally accepted standards (one of which must be a barrier method) starting at Screening and throughout the study period and for 45 days after the final study drug administration. - Female subject must agree not to breastfeed at Screening and throughout the study period, and for 45 days after the final study drug administration. - Female subject must not donate ova starting at Screening and throughout the study period, and for 45 days after the final study drug administration. - Male subject and their female partners who are of childbearing potential must be using two forms of effective contraception per locally accepted standards (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 105 days after the final study drug administration - Male subject must not donate sperm starting at Screening and throughout the study period and 105 days after the final study drug administration. - Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: - Subject was diagnosed as acute promyelocytic leukemia (APL). - Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). - Subject has AML secondary to prior chemotherapy for other neoplasms (except for MDS). - Subject is in second or later hematologic relapse or has received salvage therapy for refractory disease - Subject has clinically active central nervous system leukemia. - Subject has been diagnosed with another malignancy, unless disease-free for at least 5 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy. - Subject has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib used in first-line therapy regimen as part of induction, consolidation, and/or maintenance). - Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation (DIC). - Subject has had major surgery within 4 weeks prior to the first study dose. - Subject has radiation therapy within 4 weeks prior to the first study dose. - Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%. - Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A. - Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading. - Subjects with Long QT Syndrome at Screening. - Subjects with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal [LLN]). - Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) or substrates of multidrug and toxin extrusion protein 1 (MATE1) with the exception of drugs that are considered absolutely essential for the care of the subject - Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject. - Subject has an active uncontrolled infection. - Subject is known to have human immunodeficiency virus infection. - Subject has active hepatitis B or C, or other active hepatic disorder. - Subject has any condition which makes the subject unsuitable for study participation. - Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids for GVHD.
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