Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT01144260
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506918', 'term': 'bafetinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-14', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL', 'timeFrame': 'Upto 6 months or disease progression'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CLL', 'leukemia', 'chronic lymphocytic leukemia'], 'conditions': ['B-Cell Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).', 'detailedDescription': 'Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* B-cell chronic lymphocytic leukemia meeting the WHO criteria.\n* Relapsed or refractory disease with at least one of the following criteria: \\*progression after at least one course of a purine nucleoside analog (fludarabine phosphate, cladribine, pentostatin)\n\n * progression after at least one course of an alkylating agent (cyclophosphamide or chlorambucil)\n * relapse within 12 months after at least one course of either a purine nucleoside or an alkylating agent.\n* Capable of providing informed consent and complying with trial procedures.\n* ECOG performance status 0-2.\n* Requires chemotherapy for disease as shown by any of the following criteria:\n\n * measurable and progressive lymphocytosis\n * measurable and progressive lymphadenopathy (lymph node ≥2 cm in a single diameter)\n * either weight loss ≥10% within the past 6 months or extreme fatigue due to leukemia\n * fevers ≥100.5 degrees F for 2 weeks with no source of infection\n * night sweats with no evidence of infection\n * progressive marrow failure (worsening anemia with hemoglobin \\<10 gm/dL and/or thrombocytopenia with platelet count \\<100,000/mm3)\n * massive or progressive splenomegaly (spleen \\>6 cm below left costal margin).\n* Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. \\[Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.\\]\n* Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.\n* Accessibility to the site.\n\nExclusion Criteria:\n\n* Chemotherapy, antibody therapy, surgery within 4 weeks of study enrollment.\n* Exposure to any investigational agent within 30 days of the Screening Visit.\n* Known CNS disease.\n* Concurrent active malignancies except basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.\n* Laboratory values: Screening creatinine clearance (calculated by Cockcroft Gault formula) of less than 50 mL/minute, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count \\<3500/mm3, absolute neutrophil count \\<1000/mm3, hematocrit level \\<33% for females or \\<35% for males.\n* Clinically evident congestive heart failure \\>class II of the New York Heart Association (NYHA) guidelines.\n* Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.\n* History or signs of active coronary artery disease with or without angina pectoris.\n* Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) \\<45% of predicted.\n* Known HIV infection.\n* Uncontrolled active, infection.\n* Major surgery within 3 weeks prior to treatment.\n* Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.\n* Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study."}, 'identificationModule': {'nctId': 'NCT01144260', 'briefTitle': 'Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytRx'}, 'officialTitle': 'A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)', 'orgStudyIdInfo': {'id': 'BAFETINIB-P2-CLL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bafetinib', 'interventionNames': ['Drug: bafetinib']}], 'interventions': [{'name': 'bafetinib', 'type': 'DRUG', 'otherNames': ['INNO-406'], 'description': '250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.', 'armGroupLabels': ['Bafetinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Daniel Levitt, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CytRx'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytRx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}