[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531419":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":46,"centralContacts":51,"locations":61,"responsibleParty":77,"collaborators":55,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":55,"enrollmentInfo":89,"targetDuration":55,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":55,"overallStatus":63,"whyStopped":55,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydroxyurea (HU) + Valproic Acid (VPA) part 1","ACTIVE_COMPARATOR","Combination treatment 1 (T1): hydroxyurea + valproic acid, combination treatment 2 (T2): 6-mercaptopurine + valproic acid.\n\nEach patient enrolled will receive at least one cycle with T1: hydroxyurea and valproic acid. The 1st cycle in the study always constitutes of hydroxyurea (1000 mg twice a day) plus valproic acid (300 mg + 600 mg) for 14 days; then 14 days with no medication.\n\nEach cycle duration is 28 days. Patients who do not experience clinical benefit after 1st cycle, or experience unacceptable and unmanageable toxicity after 1st cycle, will not be eligible to continue on this regimen and they will be allocated to treatment combination 2. T2 constitutes of 6-mercaptopurine ( 50 mg once a day) plus valproic acid 300 mg + 600 mg ) for 14 days; followed by 14 days with no medication. Each cycle duration is 28 days.",[13,14,15],"Drug: Hydroxyurea, Hydroxycarbamide","Drug: Valproic acid","Drug: 6-Mercaptopurine (6-MP)",{"label":17,"type":10,"description":18,"interventionNames":19},"Hydroxyurea (HU) + Valproic Acid (VPA) part 2","Part B consists of two cohort expansions where the setup is identical to part A: one for HU + VPA and one for 6-MP + VPA, 16 patients in each, in total 32 new patients.\n\nIn part B the same principles will apply for response, withdrawal and allocation from HU+ VPA to 6-MP + VPA. The treatment duration in all arms can last to up 6 cycles in total. Each cycle duration is 28 days.",[13,14,15],[21,28,40],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Hydroxyurea, Hydroxycarbamide","Hydroxyurea (HU\u002Fhydroxycarbamide) is a hydroxylated analogue of urea which prevents DNA synthesis by inhibiting the activity of ribonucleotide reductase (RNR). HU has been used to treat a variety of diseases. As an antineoplastic drug, HU has some advantages. It may be used by ambulatory patients and has relatively few side effects, which are relieved almost immediately after withdrawal of the drug. The drug is readily absorbed from the gastrointestinal tract following oral administration. At present, HU has an important role as standard of care for treating hyperleukocytosis in chronic and acute myeloid leukemia.",[9,17],[27],"Hydroxyurea Medac",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Valproic acid","Valproic acid (VPA) has been used clinically as an anticonvulsant and mood-stabilizing drug. During the last two decades, VPA has been described as a histone deacetylase (HDAC) inhibitor and gained increased interest for use in cancer therapy. VPA is administered orally with available routine measurements of serum levels and has a low toxicity profile.",[9,17],[33,34,35,36,37,38,39],"Orfiril Long depot","Belvo","Depakote","Dyzantil","Convulex","Syonell","Epilim",{"type":22,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"6-Mercaptopurine (6-MP)","In 1953, 6-MP was an approved antileukemic agent resulting in remissions in children with acute lymphocytic leukemia (ALL). After adding 6-MP to methotrexate and prednisolone in the treatment regimen, the one-year mean survival of children with ALL was increased from 29% to 50%. 6-MP, even about 70 years after its discovery, remains the standard maintenance therapy once the children are in complete remission.",[9,17],[45],"Puri-Nethol",[47],{"name":48,"affiliation":49,"role":50},"Bjørn Tore Gjertsen, MD, PhD","Helse-Bergen HF","PRINCIPAL_INVESTIGATOR",[52,57],{"name":48,"role":53,"phone":54,"phoneExt":55,"email":56},"CONTACT","004741566248",null,"bjorn.tore.gjertsen@helse-bergen.no",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Irini Ktoridou-Valen, MD","004746664928","irini.ktoridou-valen@helse-bergen.no",[62],{"facility":5,"status":63,"city":64,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Bergen","5021","Norway","NO",{"type":69,"coordinates":70},"Point",[71,72],5.32415,60.39299,{"lat":72,"lon":71},[75,76],{"name":48,"role":53,"phone":54,"phoneExt":55,"email":56},{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},{"type":78,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100531419","phase-1-a-study-to-investigate-treatment-of-hu-and-vpa-or-6-mp-and-vpa-in-unfit-amlhr-mds-patients-100531419",false,"NCT06199557","A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML\u002FHR-MDS Patients","A Phase 1\u002F2 Multicenter Open-label Study to Investigate Treatment of Hydroxyurea in Combination With Valproic Acid (VPA), or 6- Mercaptopurine in Combination With VPA in Patients With AML or HR-MDS Unfit for Standard Therapy","HUVAMER","Inclusion Criteria:\n\nParticipants are eligible for the study only if all of the following criteria apply:\n\no Female or male, age 18 years or older\n\n* Written informed consent\n* Patients with Newly diagnosed AML, as defined by ELN 2022 criteria, or relapsed\u002Frefractory AML who: - are unfit, defined as HCT-CI ≥ 3, or - in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n\n  * the patient has declined standard therapy\n\nNewly diagnosed HR-MDS, or relapsed\u002Frefractory HR-MDS who:\n\n* are unfit, defined as HCT-CI ≥ 3, or\n* in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n* has declined standard therapy\n\nSecondary AML (MDS-related\u002F therapy- induced), or\n\nAcute promyelocytic leukemia not eligible for standard therapy and\u002For specific therapy.\n\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n\n  * Serum creatinine ≤1.5 x ULN;\n  * Estimated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault equation);\n  * Hepatic function;\n\n    i. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); ii. Aspartate aminotransferase (AST)\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iii. Alanine aminotransferase (ALT)\n\n    \u003C!-- -->\n\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iv. Alkaline phosphatase (ALP)\n\n    1\\. ≤2.5 × ULN\n* European Cooperative Oncology Group (ECOG) performance status 0, 1, 2 or 3\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to taking their first dose of study medication. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for \\>3 months after the last dose of study medication. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:\n\n  1. Natural menopause with last menses \\>1 year ago\n  2. Radiation induced oophorectomy with last menses \\>1 year ago\n  3. Chemotherapy induced menopause with last menses \\>1 year ago\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Patients on treatment for AML (any anti-leukemic therapy including investigational agents) or treated less than 2 weeks before inclusion.\n* Concurrent history of active malignancy in the past six months prior to diagnosis except for\n\n  * basal and squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease et cetera) at the investigators discretion.\n* Breastfeeding women\n* Cardiac dysfunction as defined by:\n\n  * myocardial infarction within the last 3 months of study entry, or\n  * congestive heart failure NYHA class IV or\n  * unstable angina, or\n  * unstable cardiac arrhythmias\n* SARS-CoV-2 infection \\\u003C 7 days or Covid-19-vaccine \\\u003C 7 days from study onset\n* Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.\n* Patients with any serious concomitant medical condition that could, in the opinion of the investigator, compromise participation in the study.\n* Patients with senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.\n* Known hypersensitivity to study medications or its excipients.\n* Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.","ALL","18 Years",{"count":90,"type":91},48,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","The purpose of this study is to investigate the safety, tolerability, and preliminary efficacy of the combination treatment of hydroxyurea capsules and valproic acid capsules, or the combination treatment of 6-mercaptopurine tablets and valproic acid capsules in male and female patients aged 18 years or older with acute myeloid leukemia or high- risk myelodysplastic syndrome.\n\nThe population to be studied is newly diagnosed AML patients who are considered unfit for standard induction chemotherapy, HR-MDS unfit\u002Fineligible for standard treatment, and relapsed\u002Frefractory AML\u002FHR-MDS patients who are considered unfit for standard therapy ,or are, for some reason, ineligible for another type of therapy. Clinically, hydroxyurea, valproic acid and 6-mercaptopurine are historically very well-known therapeutic agents with low toxicity profiles. The rationale for this study is that the combination of these drugs with low toxicity will be well tolerated in elderly AML patients with comorbidities, or lower performance status. This combination could have a beneficial therapeutic effect on overall survival and contribute to a better quality of life.",[98,99],"Acute Myeloid Leukemia, Adult","Myelodysplastic Syndromes, Adult","2025-06-25",{"date":102,"type":103},"2025-06-29","ACTUAL",{"date":105,"type":103},"2024-05-23",{"date":107,"type":91},"2029-09-30",{"name":5,"class":6},1]