Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT00338494
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2006-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077866', 'term': 'Clofarabine'}], 'ancestors': [{'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-28', 'studyFirstSubmitDate': '2006-06-15', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tolerated dose (MTD) of clofarabine', 'timeFrame': 'at the completion of dose escalation'}, {'measure': 'characterize and quantify the toxicity profile associated with clofarabine', 'timeFrame': 'upon completion of the study'}, {'measure': 'determine the overall response rate, plus partial response of clofarabine', 'timeFrame': 'upon completion of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute lymphocytic leukemia in children. This study is being done to see if Clofarabine works in adult patients with B-cell types of lymphoma.\n\nThis research is being done to develop new treatments for patients with lymphoma whose cancer has returned or resisted treatment with previous chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who are at least 18 years old\n* Histologically confirmed low grade or intermediate-grade B-cell lymphoma\n* Relapsed or refractory to at least one standard chemotherapy regimen. Patients who have received Rituximab alone without having received a cytotoxic agent are not eligible.\n* Measurable disease, defined by the Cheson lymphoma criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Life expectancy greater than 12 weeks\n* Laboratory values obtained ≤2 weeks prior to entry\n\n * Absolute neutrophil count (ANC) ≥ 1000 x 10 9/L\n * White blood cell (WBC) count \\> 2.5 x 10 9/L\n * Platelets ≥ 75 x 10 9/L\n * Hemoglobin (Hg) \\> 9.0 g/dL\n * Total bilirubin ≤2.0 mg/dL\n * Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × upper limit of normal (ULN)\n * Serum creatinine ≤2.0 mg/dL\n* Normal cardiac function, defined as an ejection fraction ≥45% determined by pretreatment radionuclide ventriculography (RVG) or echocardiogram.\n* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.\n* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.\n\nExclusion Criteria:\n\n* Previously untreated B-cell lymphoma.\n* Received previous treatment with clofarabine.\n* Patients with known AIDS-related or HIV-positive lymphoma.\n* Autologous bone marrow or stem cell transplant within 6 months of study entry.\n* Prior radiotherapy to the only site of measurable disease.\n* Any medical condition that requires chronic use of oral high-dose corticosteroids greater than 20 mg/day prednisone.\n* Active autoimmune thrombocytopenia.\n* Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.\n* Patients with an active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).\n* Active secondary malignancy.\n* Pregnant or lactating patients.\n* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n* Patients with active or untreated central nervous system (CNS) lymphoma.'}, 'identificationModule': {'nctId': 'NCT00338494', 'briefTitle': 'Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma', 'orgStudyIdInfo': {'id': '0506000158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Clofarabine']}], 'interventions': [{'name': 'Clofarabine', 'type': 'DRUG', 'otherNames': ['CAFdA', 'Cl-F-ara-A'], 'description': 'The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Comprehensive Cancer Center at Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Francine Foss, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}