Comparing 14 approaches for leukemia, myeloid, acute

Exclusion

• −Have a known intolerance of hypersensitivity reaction to components of the investigational medicinal product
• −Have a known detectable viral load for human immunodeficiency virus or hepatitis C, or evidence of hepatitis B surface antigen, all being indicative of active infection.
• −For sites in Japan, Taiwan, and Korea only: Hepatitis B core (HBc) antibody or hepatitis B surface (HBs) antibody test should be performed if HBsAg is negative. If HBc antibody or HBs antibody test is positive, HBV DNA quantification test should be performed to confirm that HBV DNA is negative.
• −Has a left ventricular ejection fraction (LVEF) \<50%, as determined by ECHO
• −Histological diagnosis of acute promyelocytic leukemia
• −Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336
• −Have abnormal ECGs at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → that are clinically significant, such as (QTc \>480 msec, with QTc corrected according to Fridericia's formula (QTcF). For clinical sites in the UK, have abnormal ECGs at screening that are clinically significant, such as QTc ≥470 msec and ≥450 msec with QTc corrected according to Fridericia's formula (QTcF), for females and males, respectively. In addition, patients with a history of prolonged QT syndrome or who are required to take therapies associated with QT-interval prolongation are excluded.
• −Note: In case of bundle branch block, QT interval correction can be performed.
• −Has an active and uncontrolled, bacterial, viral, or fungal infection requiring parenteral therapy. Note: Patients must be afebrile with negative blood cultures at least 72 hours prior to Cycle 1 Day 1.
• −Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4/5, including specifically: ketoconazole, isavuconazole and itraconazole. Other antifungals that are used as standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → to prevent or treat infections are permitted. If a patient is on one of the excluded azole class antifungals, he/she can be taken off or switched to a permitted azole 7 or more days prior to first dose, then the patient could be allowed on study (ArmArmOne of the groups in a study, each receiving something different.Read more → B) with approval of the medical monitor.
• −Underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. For clinical sites in the UK, underwent CAR-T therapy or other modified T-cell therapy within 6 months prior to the first dose of DSP-5336.
• −Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336, or receiving immunosuppressive therapy post-HSCT at the time of screening, or with clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD
• −Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 7 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336
• −In the opinion of the treating investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, have any concurrent conditions that could pose an undue medical hazard or interfere with interpretation of study results; these conditions include, but are not limited to: clinically significant non-healing or healing wounds; concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV; see Section 21.2); concurrent unstable angina; concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation); recent (within the prior 6 months) myocardial infarction; acute coronary syndrome within the previous 6 months; significant pulmonary disease (shortness of breath at rest or on mild exertion), eg, due to concurrent severe obstructive pulmonary disease, concurrent hypertension not controlled with concomitant medication, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 6 months
• −Have severe dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication
• −Have cognitive, psychological, or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocolProtocolThe detailed plan a study must follow.Read more →, or adversely affect the ability of the patient to comply with the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → process, protocol, or protocol-required visits and procedures
• −Have any history or complication of interstitial lung disease (for sites in Japan in Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → dose escalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more →).
• −For clinical sites in the EU, have a history of Grade ≥ 2 drug-induced interstitial lung disease or Grade ≥ 2 non-infectious pneumonitis within 6 months of starting study treatment.
• −Have a history of Torsades de Pointes
• −Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336
• −Have plasma cell leukemia (\>2.0 x 109 /L plasma cells in blood by standard differential) (for patients with MM)
• −For patients intending to enroll into the combination cohortCohortA group of participants sharing a characteristic, followed together.Read more → with gilteritinib: Patients must be gilteritinib-naïve or sensitive and have not received a FLT3 inhibitor in the relapsed refractory setting (prior FLT3 inhibitor in front line therapy is allowed)
• −For clinical sites in the UK: In Arm E (DSP-5336 + venetoclax/azacitidine), have received a live vaccine within 30 days prior to the first dose of DSP-5336
• −Are pregnant or breastfeeding or planning to become pregnant. Note: Patients who are breastfeeding may be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → if they interrupt breastfeeding prior to the first dose of any study drugs and do not feed the baby with breast milk expressed after receiving the first dose of any study drugs. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug
• −Had major surgery within 28 days prior to the first dose of DSP-5336
• −Has active central nervous system leukemia (prophylactic intrathecal chemotherapy is allowed).