Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-09 @ 10:42 PM
Study NCT ID:
NCT03599960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2018-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Patients With Newly Diagnosed BPDCN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000099067', 'term': 'Blastic Plasmacytoid Dendritic Cell Neoplasm'}], 'ancestors': [{'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will receive 3 cycles of a combination of chemotherapy (Met/Ida/L-Asp/Dex)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Minimal residual disease analysis', 'timeFrame': '24 months', 'description': 'presence of PDC cell blast (CD56 +, NG2 +, BDCA2low, BDCA4low, CD123low, cTCL1high as measured by flow cytometry)'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with complete response after 3 cycles of chemotherapy', 'timeFrame': '12 weeks (3 weeks after 3 cycles of chemotherapy (each cycle is 21 days))', 'description': 'Proportion of patients with complete response after 3 cycles of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with response (complete or partial) after 3 cycles of chemotherapy', 'timeFrame': '12 weeks (3 weeks after 3 cycles of chemotherapy (each cycle is 21 days))', 'description': 'Proportion of patients with response (complete or partial) after 3 cycles of chemotherapy'}, {'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'Overall survival'}, {'measure': 'Relapse-free survival', 'timeFrame': '24 months', 'description': 'Relapse-free survival'}, {'measure': 'Residual L-asparaginase activity', 'timeFrame': '12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days))', 'description': 'Residual L-asparaginase activity'}, {'measure': 'Anti-L-asparaginase antibodies levels', 'timeFrame': '12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days))', 'description': 'Evaluation of the titer of the anti-asparaginase antibody'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)']}, 'descriptionModule': {'briefSummary': 'Patients with suspected BPDCN and meeting eligibility criteria will be enrolled in the study. First, BPDCN diagnosis will be confirmed by anatomic pathology (Dr Petrella T, Montreal) and cytologic plus immunophenotyping analysis (Pr Garnache Ottou F, UMR1098 BESANCON). Patients will then receive three 21 days cycles of a combination of chemotherapy (Ida/Metho/L-asp/Dex), followed by an evaluation. Patients with complete response (CR) or complete response with incomplete bone marrow recovery (CRi) will undergo an allo- or auto-SCT and those who are not eligible to the transplantation will have successive 28 days cycles of chemotherapy (Metho/L-asp/Dex). Patients who did not respond to the treatment will be treated by physicians. All patients will be followed for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed BPDCN established by a blood or bone marrow immunophenotypic diagnosis by flow cytometric and/or by the anatomic pathology study of a skin biopsy using validated diagnostic criteria (Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008; Garnache-Ottou et al., 2009; Angelot et al., 2012; Julia et al., 2014) or patients with confirmed isolated skin lesion.\n* 18 years of age or older\n* No prior cytotoxic therapy except \\<2 week of corticosteroids or hydroxyurea\n* ECOG ≤2\n* Written informed consent\n* Affiliation to the French social security scheme\n\nExclusion Criteria:\n\n* Cardiac contra-indication to anthracyclines: cardiac dysfunction events (NYHA grade 3 or 4 and/or LVEF\\<50%)\n* Hepatocellular abnormalities except if considered related to the BPDCN:\n\n 1. ASAT (SGOT) and/or ALAT (SGPT) \\> 5 x ULN\n 2. Total bilirubin ≥ 2.5 x ULN\n* Creatinine level \\>1.5x ULN or creatinine clearance (MDRD)\\<50 mL/mn\n* Prior thrombotic event\n* Active hepatitis B or C virus infection\n* HIV positive\n* Serious medical or psychiatric illness that could interfere with the completion of treatment\n* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n* Pregnant and lactating female patients\n* Patients diagnosed with or treated for another malignancy within 2 years before study enrollment or with residual disease (basal cell carcinoma or cervical carcinoma in situ patients may be enrolled if they have undergone complete resection)'}, 'identificationModule': {'nctId': 'NCT03599960', 'acronym': 'LpDessai', 'briefTitle': 'Combination Chemotherapy in Patients With Newly Diagnosed BPDCN', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)', 'orgStudyIdInfo': {'id': 'LpDessai'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': '* Idarubicin 12mg/m2 IV at D1\n* Methotrexate at D1 (24H infusion, alkaline hydration, leucovorin rescue):\n\n * Patients \\<65y and albuminemia \\>35 g/l and CrCl (MDRD)\\>60 ml/min: 3000 mg/m²\n * Patients \\<65y and albuminemia \\<35 g/l and/or CrCl (MDRD) \\<60 ml/min: 1000 mg/m² IV\n * Patients ≥65y and albuminemia \\>35 g/l and CrCl (MDRD) \\> 60 ml/min : 1000 mg/m²\n * Patients ≥ 65y and albuminemia \\< 35 g/l and/or CrCl (MDRD) \\< 60 ml/min : 500 mg/m²\n* L-asparaginase (SPECTRILA) : 5000 units/m² IV at D2, 5, 8, 11 (switch to Erwinia asparaginase/Cirsantaspase 25 000 U/m² with the same drug regimen in case of hypersensitivity reactions or significant diminution of asparaginase activity)\n* Dexamethasone 40mg PO or IV at D1-4 (dose diminution at 20 mg for Age ≥65y)', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80090', 'city': 'Amiens', 'country': 'France', 'facility': "Clinique de L'Europe", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Chu Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMR1098, EFS BFC, BESANCON', 'class': 'UNKNOWN'}, {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'Inserm CIC1431, CHU Besancon', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}