Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-06 @ 7:35 AM
Study NCT ID:
NCT07259161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Conditioning Regimen for CML-BP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival, OS', 'timeFrame': '2 year'}], 'secondaryOutcomes': [{'measure': 'Relapse free survival, RFS', 'timeFrame': '2 year'}, {'measure': 'TRM', 'timeFrame': '2 year', 'description': 'Treatment relater mortality'}, {'measure': 'CIR', 'timeFrame': '2 year', 'description': 'cumulative incidence of relapse'}, {'measure': 'safety and toxicity of conditioning regimen', 'timeFrame': '2 year', 'description': 'Evaluate the side effects and safety of the regimen, using Bearman score system'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CML,Blast Phase', 'HSCT']}, 'descriptionModule': {'briefSummary': 'Study on the Efficacy and Safety of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan in Patients with Blast Phase Chronic Myeloid Leukemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (1) Confirmed diagnosis of blast-phase chronic myeloid leukemia, with diagnostic criteria referring to the 2020 Chinese Guidelines for Diagnosis and Treatment of Chronic Myeloid Leukemia.\n\nDiagnostic criteria for chronic myeloid leukemia: Typical clinical manifestations combined with the presence of Philadelphia chromosome and/or BCR-ABL fusion gene positivity confirm the diagnosis.\n\nDiagnostic criteria for blast phase:\n\n1. Peripheral blood or bone marrow blasts ≥20%\n2. Aggregates of blasts on bone marrow biopsy\n3. Extramedullary blast cell infiltration (2) Age ≥18 years (3) Ability to provide self-signed informed consent (4) Must meet adequate organ function requirements:\n\nRenal and hepatic function as follows:\n\nAST, ALT and ALP \\<2× upper limit of normal (ULN) Total bilirubin \\<1.5× ULN Creatinine clearance \\>50 mL/min\n\nPancreatic function:\n\nSerum amylase ≤1.5× ULN Serum lipase ≤1.5× ULN\n\nNormal cardiac function:\n\nEjection fraction (EF) \\>60% Pulmonary artery systolic pressure ≤50 mmHg (5) HIV negative, HBV negative, HCV negative (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2 (7) Signed informed consent must be obtained before study procedures begin. For subjects aged 18 years or older, informed consent shall be signed by the patient themselves or direct family members. Considering the patient's medical condition, if the patient's own signature is medically inadvisable, the informed consent shall be signed by a legal guardian or the patient's direct family member.\n\nExclusion Criteria:\n\n* 1\\. (1) Patients with previous autologous or allogeneic stem cell transplantation; (2) Patients concurrently diagnosed with other malignant tumors; patients assessed by investigators as having concomitant diseases that severely endanger their life safety or affect their ability to complete this study; (3) Patients with psychiatric disorders or other medical conditions that cannot comply with the requirements of study treatment and monitoring; (4) Patients unable or unwilling to sign the consent form; (5) Pregnant or lactating women; (6) Patients assessed by investigators as ineligible due to other special circumstances."}, 'identificationModule': {'nctId': 'NCT07259161', 'briefTitle': 'Modified Conditioning Regimen for CML-BP', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Prospective, Single-Arm Study on the Efficacy of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan for Patients With Blast Phase Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'IIT2025094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'modified conditioning regimen', 'interventionNames': ['Drug: Enrolled patients with blast-phase chronic myeloid leukemia received a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine prior to undergoing allogeneic hematopoie']}], 'interventions': [{'name': 'Enrolled patients with blast-phase chronic myeloid leukemia received a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine prior to undergoing allogeneic hematopoie', 'type': 'DRUG', 'description': 'This study is a prospective, interventional clinical trial recruiting patients with blast-phase chronic myeloid leukemia from the Stem Cell Transplantation Center of the Institute of Hematology \\& Blood Diseases Hospital, Chinese Academy of Medical Sciences, with an anticipated enrollment of 40 cases. Enrolled patients are scheduled to receive a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine for allogeneic hematopoietic stem cell transplantation. Thiotepa 5mg/kg on days -8 and -7, melphalan 60mg/m2 on days -5 and -4, Flu 30mg/m2 from day -6 to day -2.', 'armGroupLabels': ['modified conditioning regimen']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Erlie Jiang', 'role': 'CONTACT', 'email': 'jiangerlie@ihcams.ac.cn', 'phone': '022-23608569'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}