Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-12 @ 7:17 PM
Study NCT ID:
NCT00496132
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
2007-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C550338', 'term': 'PRO131921 monoclonal antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2013-01-18', 'completionDateStruct': {'date': '2009-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2007-07-03', 'dispFirstSubmitQcDate': '2013-01-18', 'studyFirstSubmitQcDate': '2007-07-03', 'dispFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities and adverse events', 'timeFrame': 'Length of study'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters; CD19-positive B-cell counts', 'timeFrame': 'Length of study'}, {'measure': 'Overall response rate and progression-free survival (Phase II only)', 'timeFrame': 'Length of study'}]}, 'conditionsModule': {'keywords': ['CLL', 'Leukemia', 'Lymph'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented history of histologically confirmed B-cell CLL\n* Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen\n* Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL\n* For patients of reproductive potential (males and females), use of a reliable means of contraception\n* For females of childbearing potential, a negative serum pregnancy test\n\nExclusion Criteria:\n\n* Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)\n* Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment\n* Current or recent CLL treatment\n* History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies\n* Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL\n* Use of hematopoietic growth factors or RBC and/or platelet transfusions\n* Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders\n* Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination\n* History of cancer other than CLL)\n* Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics\n* A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening\n* Positive hepatitis B or C serology\n* Positive human immunodeficiency virus (HIV) serology\n* Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing\n* Pregnancy or lactation\n* CNS leukemia\n* Recent major surgery, other than diagnostic surgery'}, 'identificationModule': {'nctId': 'NCT00496132', 'briefTitle': 'A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen', 'orgStudyIdInfo': {'id': 'ACO4198g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: PRO131921']}], 'interventions': [{'name': 'PRO131921', 'type': 'DRUG', 'description': 'Escalating doses by IV infusion', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bill Ho, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}