Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06584006
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D008231', 'term': 'Lymphopenia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077596', 'term': 'Thymalfasin'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-09-02', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymphocyte count and its subgroup count', 'timeFrame': 'Up to 36 months', 'description': 'Dynamic changes in lymphocyte count and its subgroup count'}], 'secondaryOutcomes': [{'measure': 'NK cells', 'timeFrame': 'Up to 36 months', 'description': 'Changes in NK cells'}, {'measure': 'Infection', 'timeFrame': 'Up to 36 months', 'description': 'Incidence of infections'}, {'measure': 'Treatment interruption', 'timeFrame': 'Up to 36 months', 'description': 'Rate of treatment interruption or delay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematological Malignancy', 'Lymphocytopenia']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors', 'detailedDescription': 'A prospective, randomized controlled study is proposed to evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Recombinant Human Interleukin-2 Injections as a monotherapy, and a non-intervention group. Follow-up observations will also be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.\n2. Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.\n3. Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.\n4. Estimated creatinine clearance rate ≥ 30 mL/min.\n5. AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.\n6. ECOG ≤ 2.\n7. Able to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n1. Active autoimmune disease.\n2. Patients considered to have a malignant T-cell clone.\n3. Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.\n4. Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils \\<1.0×10\\^9/L, HB\\<70g/L, PLT\\<50×10\\^9/L).\n5. HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).\n6. Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.\n7. Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1/2 inhibitors, etc.) within the past 5 days.\n8. Psychiatric disorders that would interfere with study participation.\n9. Patients who have undergone allogeneic hematopoietic stem cell transplantation.\n10. Consideration of allergy to Thymalfasin or Interleukin-2.\n11. Any other condition that the researcher believes makes the patient unsuitable for this trial.'}, 'identificationModule': {'nctId': 'NCT06584006', 'briefTitle': 'Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'A Phase II, Single-Center, Randomized Controlled Clinical Trial Evaluating the Efficacy of Thymalfasin and Recombinant Human Interleukin-2 Injections in Treating Lymphocytopenia in Patients With Malignant Hematological Tumors', 'orgStudyIdInfo': {'id': 'XMDYYYXYK-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Therapy Group', 'description': 'Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections', 'interventionNames': ['Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections']}, {'type': 'EXPERIMENTAL', 'label': 'Monotherapy Group', 'description': 'Recombinant Human Interleukin-2 Injections as a monotherapy', 'interventionNames': ['Drug: Recombinant Human Interleukin-2 Injections']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'non-intervention'}], 'interventions': [{'name': 'Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections', 'type': 'DRUG', 'otherNames': ['Combination Therapy Group'], 'description': 'Thymalfasin for injection 1.6mg subcutaneous injection once daily (qd) for 7 days, and Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.', 'armGroupLabels': ['Combination Therapy Group']}, {'name': 'Recombinant Human Interleukin-2 Injections', 'type': 'DRUG', 'otherNames': ['Monotherapy Group'], 'description': 'Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.', 'armGroupLabels': ['Monotherapy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijuan Lin', 'role': 'CONTACT', 'email': 'zjuan_lin@126.com', 'phone': '15960283462'}], 'facility': 'Zhijuan Lin', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Zhijuan Lin', 'role': 'CONTACT', 'email': 'zjuan_lin@126.com', 'phone': '15960283462'}], 'overallOfficials': [{'name': 'Zhijuan Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Aiffiliated hosptical of xiamen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhijuan Lin', 'investigatorAffiliation': 'The First Affiliated Hospital of Xiamen University'}}}}