Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT05137860
Status:
UNKNOWN
Last Update Posted:
2022-01-18
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical Randomized Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-02', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Outcome', 'timeFrame': '3 months', 'description': 'The event in which patient is discharge from Hospital stay.'}, {'measure': 'Hospital stay', 'timeFrame': '3 months', 'description': 'Time in which patients stay in the Hospital before discharge'}, {'measure': 'Leukocytes count', 'timeFrame': '3 months', 'description': 'Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle'}, {'measure': 'Platelets count', 'timeFrame': '3 months', 'description': 'Number of platelets found in peripheral blood at the end of each chemotherapy cycle'}, {'measure': 'Date of Remission', 'timeFrame': '3 month', 'description': 'Time in which the patient completes remission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute lymphoblastic leukemia', 'Bortezomib', 'Relapse', 'Minimal Residual Disease', 'Toxicity'], 'conditions': ['Acute Lymphoblastic Leukemia, in Relapse', 'Chemotherapeutic Toxicity', 'Minimal Residual Disease']}, 'referencesModule': {'references': [{'pmid': '8197160', 'type': 'BACKGROUND', 'citation': 'Burton JD, Bamford RN, Peters C, Grant AJ, Kurys G, Goldman CK, Brennan J, Roessler E, Waldmann TA. A lymphokine, provisionally designated interleukin T and produced by a human adult T-cell leukemia line, stimulates T-cell proliferation and the induction of lymphokine-activated killer cells. Proc Natl Acad Sci U S A. 1994 May 24;91(11):4935-9. doi: 10.1073/pnas.91.11.4935.'}, {'pmid': '28116786', 'type': 'RESULT', 'citation': 'Bertaina A, Vinti L, Strocchio L, Gaspari S, Caruso R, Algeri M, Coletti V, Gurnari C, Romano M, Cefalo MG, Girardi K, Trevisan V, Bertaina V, Merli P, Locatelli F. The combination of bortezomib with chemotherapy to treat relapsed/refractory acute lymphoblastic leukaemia of childhood. Br J Haematol. 2017 Feb;176(4):629-636. doi: 10.1111/bjh.14505. Epub 2017 Jan 24.'}, {'pmid': '30957229', 'type': 'RESULT', 'citation': "Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7."}]}, 'descriptionModule': {'briefSummary': 'Various drugs have been added to different treatment regimens in order to improve the response rate in patients with Acute Lymphoblastic Leukemia, however, it has been shown that adding Bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. Therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.', 'detailedDescription': 'Mortality associated with leukemia has decreased due to the use of various chemotherapy combinations, the addition of new agents, or the chemical modification of existing drugs. Despite advances in treatment, the prognosis in the adult population continues to be unfavorable. About 25% of the patients will be refractory to the first treatment regimen and the rest will have a disease-free survival below 40%. The chemotherapy intensity reduction strategy based on risk stratification according to Minimal Residual Disease (MRD) is a strategy used by various pediatric centers in order to detect patients at high risk of relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmatory diagnosis of Acute Lymphoblastic Leukemia relapsed to bone marrow described with more than 5% blasts in bone marrow at any stage of treatment or positivity of minimal residual disease at any stage of treatment.\n* Patients who have signed their informed consent from the institution for hospitalization, and accepted the performance of the bone marrow study, and the administration of chemotherapy.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of phenotypic leukemia or bilinear leukemia\n* Patients treated only with palliative regimen or transfusion support\n* Patients without the administration of prophylaxis to the central nervous system by intrathecal chemotherapy\n* Patients with lymphoblastic leukemia with a positive Philadelphia chromosome\n* Patients with severe comorbidities may put treatment therapy at risk.\n* Patient with a history of cardiac toxicity or arrhythmias associated with treatment'}, 'identificationModule': {'nctId': 'NCT05137860', 'briefTitle': 'Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital General de Mexico'}, 'officialTitle': 'Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease', 'orgStudyIdInfo': {'id': 'HGMDI/21/204/03/67'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care Group', 'description': 'Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator.'}, {'type': 'EXPERIMENTAL', 'label': 'Bortezomib Treatment Group', 'description': 'Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme in combination with Bortezomib for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator.', 'interventionNames': ['Drug: Bortezomib']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Intervention Group'], 'description': 'Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse.', 'armGroupLabels': ['Bortezomib Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06720', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Christian O Ramos Peñafiel, PhD', 'role': 'CONTACT', 'email': 'leukemiachop@hotmail.com', 'phone': '+52 55 2789 2000', 'phoneExt': '2020'}, {'name': 'Adan G Gallardo-Rodriguez, MSc', 'role': 'CONTACT', 'email': 'nutriologo.agallardo8@gmail.com', 'phone': '+52 55 2789 2000', 'phoneExt': '2020'}, {'name': 'Carlos Martínez Murillo, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Humberto Castellanos Sinco, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Odín de la Mora Estrada, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital General de México "Dr. Eduardo Liceaga"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Christian O Ramos Peñafiel, PhD', 'role': 'CONTACT', 'email': 'leukemiachop@hotmail.com', 'phone': '+52 55 27892000', 'phoneExt': '2020'}, {'name': 'Adan G Gallardo Rodriguez, MSc', 'role': 'CONTACT', 'email': 'nutriologo.agallardo8@gmail.com', 'phone': '+52 55 27892000', 'phoneExt': '2020'}], 'overallOfficials': [{'name': 'Adolfo Martinez Tovar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital General de Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General de Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Omar Ramos-Peñafiel, MD, PhD', 'investigatorAffiliation': 'Hospital General de Mexico'}}}}