Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-22 @ 1:43 AM
Study NCT ID:
NCT06927232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZA+Lus VS AZA Monotherapy in HR-MDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C000621232', 'term': 'luspatercept'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-13', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '3 months, 6 months'}], 'secondaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': '3 months, 6 months'}, {'measure': 'rate of transfusion independence', 'timeFrame': '3 months, 6 months'}, {'measure': 'adverse event rate', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'relapse rate', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'progress-free survival', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'overall survival', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['luspatercept', 'azacitidine', 'higher-risk myelodysplastic syndrome'], 'conditions': ['Higher-risk Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.', 'detailedDescription': 'The hypomethylating agents (HMA) azacitidine (AZA) and decitabine (DEC) have been shown to improve survival and delay disease progression in patients with high-risk MDS. They are recommended by the NCCN as first-line treatments for patients with high-risk MDS. Clinical trials have demonstrated an OR rate of approximately 40-50% with AZA in patients with high-risk MDS. Despite the efficacy of HMA therapy, the rate of transfusion independence remains low. Anemia remains the most prominent symptom in refractory patients, with very limited options for subsequent treatment. Prolonged anemia affects every organ function and seriously affects the prognosis of patients.\n\nLuspatercept is currently approved for the treatment of patients with both erythropoiesis receptor agonist ( ESA) treatment failures in transfusion-dependent low-risk MDS-RS patients. In a randomized controlled phase III clinical trial, compared to a placebo group, luspatercept significantly improved transfusion dependence and improved hemoglobin and quality of life in refractory MDS-RS patients. A recent conference report suggested that there was no significant difference in efficacy between low-risk and high-risk patients treated with luspatercept and that the HI rate for high-risk patients treated with luspatercept monotherapy was approximately 50%.\n\nThus this study aimed to compare the efficacy of AZA+luspatercept and AZA monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Diagnosed as higher-risk MDS (IPSS intermediate-2/high-risk, or IPSS-R \\>3.5, or IPSS-M moderate high-, high-, very high-risk)\n* Untreated patients\n* Liver and kidney function less than 2 times of upper limit of normal\n* ECOG≤2 and expected survival more than 6 months\n* Informed consent signed\n\nExclusion Criteria:\n\n* With active infection\n* Other malignant tumors\n* Obvious abnormal liver and kidney function, or abnormal function of other organs\n* Combined with myelofibrosis\n* Have undergone bone marrow transplantation\n* Pregnant or lactating women, or men who have recent reproductive needs\n* Allergic to azacytidine, Rotercept or excipients\n* History of polysorbate 80 allergy\n* Refuse to sign informed consent\n* Researchers consider it inappropriate to participate in the experiment'}, 'identificationModule': {'nctId': 'NCT06927232', 'briefTitle': 'AZA+Lus VS AZA Monotherapy in HR-MDS', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Azacitidine Plus Luspatercept Versus Azacitidine Monotherapy in Higher-risk Myelodysplastic Neoplasms: a Randomized Prospective Study', 'orgStudyIdInfo': {'id': 'AZA-Lus-HRMDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azacitidine+Luspatercept', 'interventionNames': ['Drug: Azacitidine (AZA)', 'Drug: Luspatercept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azacitidine', 'interventionNames': ['Drug: Azacitidine (AZA)']}], 'interventions': [{'name': 'Azacitidine (AZA)', 'type': 'DRUG', 'description': 'Azacitidine 75mg/m/ day \\*5 days, 28 days for 1 course', 'armGroupLabels': ['Azacitidine', 'Azacitidine+Luspatercept']}, {'name': 'Luspatercept', 'type': 'DRUG', 'description': 'Luspatercept 1.0 mg/kg subcutaneously every 3 weeks, adjusted according to hemoglobin, up to 1.75mg/kg. If hemoglobin ≥120g/L, luspatercept can be discontinued.', 'armGroupLabels': ['Azacitidine+Luspatercept']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bing Han', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}