Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 3:37 PM
Study NCT ID:
NCT05923502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586691', 'term': 'duvelisib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AE)', 'timeFrame': 'From the first day of medication to 30 days after the last dose]', 'description': 'The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 6 cycles of therapy (each cycle is 28 days)]', 'description': 'Defined as the best response of complete response/remission (CR) or partial response/remission (PR).'}, {'measure': 'Duration of remission (DOR)', 'timeFrame': '4 year', 'description': 'Time from reaching CR or PR for the first time to disease progression.'}, {'measure': 'Progression-Free-Survival (PFS)', 'timeFrame': '4 year', 'description': 'From date of inclusion to date of progression, relapse, or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '4 year', 'description': 'From the date of inclusion to date of death, irrespective of cause.'}, {'measure': 'Quality of life (QOL)', 'timeFrame': '4 year', 'description': 'The quality of life scale, ranging from 0 to 100. A score of 0 represents the worst health and a score of 100 represents the best health.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NHL; Duvelisib'], 'conditions': ['Follicular Lymphoma', 'Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma', 'Richter Syndrome', 'Marginal Zone Lymphoma', 'Peripheral T Cell Lymphoma', 'Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': "This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.", 'detailedDescription': "This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Population who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;\n* Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));\n* Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:\n\n 1. Follicular lymphoma (FL);\n 2. Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS);\n 3. Marginal zone lymphoma (MZL);\n 4. Peripheral T-cell lymphoma (PTCL);\n 5. Diffuse large B-cell lymphoma (DLBCL).\n* Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;\n* Must have adequate organ function defined by the following laboratory parameters:\n\n 1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 0.5 × 10\\^9/L, Platelet count (PLT) ≥ 25 × 10\\^9/L, blood transfusion can be used before medication;\n 2. Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN;\n 3. Estimated creatinine clearance value ≥30 milliliters/minute (as determined by the Cockcroft-Gault method).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Patients with infections should be treated first and then considered for enrollment when the infection is under control.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant or breastfeeding;\n* Estimated lifetime is less than 3 months;\n* In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment;\n* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function;\n* Prior history of drug-induced colitis or drug-induced interstitial pneumonia;\n* Known hypersensitivity to Duvelisib or its excipients;\n* Administration of medications or foods that are strong inhibitors or inducers of CYP3A beginning 2 weeks prior to the first dose of Duvelisib;\n* According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study."}, 'identificationModule': {'nctId': 'NCT05923502', 'briefTitle': "(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)", 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': "(CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).", 'orgStudyIdInfo': {'id': 'CSPC-PI3K-NHL-K01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All enrolled patients.', 'description': 'All patient who signed the consent form for participation to the study.', 'interventionNames': ['Drug: Duvelisib']}], 'interventions': [{'name': 'Duvelisib', 'type': 'DRUG', 'otherNames': ['Copiktra'], 'description': 'This is a real-word. The treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients.', 'armGroupLabels': ['All enrolled patients.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Weili Zhao, PhD', 'role': 'CONTACT', 'email': 'zwl_trial@163.com', 'phone': '021-64370045'}], 'overallOfficials': [{'name': 'Weili Zhao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}