Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT04843267
Status:
UNKNOWN
Last Update Posted:
2021-04-13
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate after two cycles of tislelizumab', 'timeFrame': '6 weeks', 'description': 'complete response rate after two cycles of tislelizumab by PET/CT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hodgkin Lymphoma', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'The experimental drug regimen in this study includes a PD-1 antibody (tislelizumab) single-drug induction treatment period and a PD-1 antibody + AVD combined treatment period.\n\n1. PD-1 antibody (tislelizumab) single-drug induction treatment period (first 2 courses for all patients + 3-6 courses for CR patients):\n\n PD-1 antibody (tislelizumab), specification: 100mg/bottle. Usage and dosage: intravenous drip, 200mg each time, QD, D1. In the above PD-1 antibody single-drug regimen, 21 days are regarded as a treatment cycle, and all patients first receive 2 courses of PD-1 antibody single-drug induction treatment;\n2. PET/CT mid-term efficacy evaluation used for guiding follow-up treatment options:\n\n PET/CT efficacy evaluation before the 3rd course of treatment (PET/CT2):\n\n CR patients: continue to receive PD-1 antibody monotherapy, and then receive 4 courses of PD-1 antibody therapy; PR patients: sequential 4 courses of PD-1 antibody + AVD combined chemotherapy; PD+SD patients: out group, and receive other anti-lymphoma therapy deemed suitable by the investigators;\n\n After the 6th course, patients not out of the group receive PET/CT3 efficacy evaluation:\n\n CR patients: end the treatment and enter the follow-up; PR patients: receive 2 more courses of PD-1 antibody + AVD combined chemotherapy, and then enter the follow-up.\n3. PD-1 antibody + AVD combined treatment period (3rd-6th/8th course for PR patients):\n\nPD-1 antibody, specification: 100mg/bottle. Usage and dosage: intravenous drip, 100mg each time, QD, d1, d15. AVD regimen Doxorubicin 25mg/m2, d1, d15 intravenous injection Vindesine 3mg/m2, d1, d15 intravenous injection Dacarbazine 0.375mg/m2, d1, d15 intravenous drip In this combined treatment regimen, every 28 days is a treatment cycle, and the PD-1 antibody is used in combination with AVD in D1 and D15 of each treatment cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed by histopathology;\n2. Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard)\n3. Patients not suitable for receiving radiotherapy subsequently\n4. Patients with at least one assessable lesion (according to Lugano 2014 standard);\n5. Age 18 or above (including 18), no gender requirement;\n6. ECOG PS score of 0-1 points;\n7. Expected survival time ≥ 3 months;\n8. Hematopoietic function: absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/L; liver function: for patients with non-hepatitis B, total bilirubin, ALT and AST \\<1.5×ULN (upper limit of normal); patients with hepatitis B need to take effective antiviral drugs, and HBV-DNA copy \\<2000 IU/ml and ALT\\<2×ULN; renal function: creatinine \\<1.5×ULN and creatinine clearance rate ≥50ml/min;\n9. With normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy;\n10. Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment;\n11. Voluntarily signing an informed consent form before trial screening.\n\nExclusion Criteria:\n\n1. Nodular lymphocyte predominant HL;\n2. Patients received any form of anti-tumor therapy in the past;\n3. Patients planning to receive radiotherapy or autologous stem cell transplantation;\n4. With involvement of central nervous system (meninges or brain parenchyma);\n5. Pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures;\n6. Patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation;\n7. Patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment;\n8. Patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment,\n9. Patients with known active interstitial pneumonia;\n10. Abnormal liver function (total bilirubin\\>1.5×ULN, ALT/AST\\>2.5×ULN or ALT/AST\\>5×ULN for patients with liver invasion), abnormal renal function (serum creatinine\\>1.5×ULN), abnormal electrolyte metabolism;\n11. Peripheral neuropathy ≥ Grade 2;\n12. Patients with a history of prolonged QT interval which is of clinical significance (male\\> 450ms, female\\> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), patients with symptomatic coronary heart disease requiring drug therapy;\n13. Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography;\n14. Mentally disturbed/patients unable to give informed consent;\n15. Patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse;\n16. Participating in another interventional clinical study at the same time; Patients not suitable to participate in this trial by the judgment of investigators.'}, 'identificationModule': {'nctId': 'NCT04843267', 'briefTitle': "A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT", 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': "A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT", 'orgStudyIdInfo': {'id': 'B2020-324-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'description': "Tislelizumab in first-line treatment of Hodgkin's lymphoma"}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiming Li', 'role': 'CONTACT', 'email': 'lizhm@sysucc.org.cn', 'phone': '+86-020-87343765'}], 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Zhiming', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}