Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-29 @ 5:30 AM
Study NCT ID:
NCT00077493
Status:
SUSPENDED
Last Update Posted:
2007-12-28
First Post:
2004-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}], 'ancestors': [{'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C431326', 'term': 'RFB4(dsFv)-PE38 recombinant immunotoxin'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}], 'ancestors': [{'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}}, 'statusModule': {'whyStopped': 'protocol development and Amended protocol revision', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-21', 'studyFirstSubmitDate': '2004-02-10', 'studyFirstSubmitQcDate': '2004-02-11', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of efficacy, safety, pharmacokinetics, immunogenicity.', 'timeFrame': 'end of study'}], 'secondaryOutcomes': [{'measure': 'Expansion of MTD', 'timeFrame': 'end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent childhood acute lymphoblastic leukemia', 'Burkitt lymphoma', 'recurrent childhood large cell lymphoma', 'recurrent childhood lymphoblastic lymphoma', 'childhood non-Hodgkin lymphoma'], 'conditions': ['Leukemia', 'Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma.\n* Determine the maximum tolerated dose of this drug in these patients.\n* Determine the immunogenicity of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n\nSecondary\n\n* Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia.\n* Determine the therapeutic efficacy of this drug in inducing remissions in these patients.\n* Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug.\n\nOUTLINE: This is a non-randomized, dose-escalation study.\n\nPatients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.\n\nCohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, the cohort is expanded and a total of 12 patients are treated at that dose.\n\nPatients are followed weekly for at least 1 month and then every 1-3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 95 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma)\n\n * Not amenable to available curative therapies\n* Relapsed or refractory disease after at least 1 standard chemotherapy and 1 salvage regimen\n* CD22 positive according to at least 1 of the following criteria:\n\n * More than 15% CD22-positive malignant cells by immunohistochemistry\n * More than 30% CD22-positive malignant cells by fluorescent-activated cell sorter analysis\n* Measurable or evaluable disease\n* Prior CNS involvement allowed provided there is no current evidence of CNS malignancy\n* No CNS leukemia or lymphoma as manifested by any of the following:\n\n * Cerebrospinal fluid (CSF) WBC ≥ 5/mm\\^3 and confirmation of CSF blasts\n * Cranial neuropathies secondary to underlying malignancy\n * Radiologically detected CNS lymphoma\n* No isolated testicular ALL\n* Ineligible for or refused hematopoietic stem cell transplantation OR has disease activity that prohibits the time required to identify a suitable stem cell donor\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 6 months to 24 years\n\nPerformance status\n\n* ECOG 0-3 (12 to 24 years of age)\n* Lansky 40-100% (under 12 years of age)\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* See Disease Characteristics\n* Absolute neutrophil count \\> 1,000/mm\\^3 \\*\n* Platelet count \\> 50,000/mm\\^3 \\* NOTE: \\*Non-leukemic patients only\n\nHepatic\n\n* Bilirubin ≤ 2.0 mg/dL\n* AST and ALT ≤ 5 times upper limit of normal\n* No active hepatitis B or C infection\n\nRenal\n\n* Creatinine normal for age OR\n* Creatinine clearance ≥ 60 mL/min\n\nImmunologic\n\n* No serum neutralization of more than 75% of the activity of 1 µg/mL of study drug\n* HIV negative\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No clinically significant unrelated systemic illness that would preclude study participation\n* No other significant organ dysfunction that would preclude study participation\n* No psychiatric illness or social situation that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* At least 1 week since prior colony-stimulating factors (e.g., filgrastim \\[G-CSF\\], sargramostim \\[GM-CSF\\], or epoetin alfa)\n* Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) allowed\n* More than 100 days since prior allogeneic HSCT\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n\nEndocrine therapy\n\n* Concurrent corticosteroids allowed provided there has been no increase in the dose 1 week prior to and after study entry\n\n * Steroid taper allowed\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy\n\n * Allowed in the past 3 weeks provided the volume of the bone marrow treated is \\< 10% AND the patients has measurable disease outside of the radiation port\n\nSurgery\n\n* Not specified\n\nOther\n\n* Recovered from prior therapy\n* At least 30 days since prior investigational drugs\n* No other concurrent investigational drugs"}, 'identificationModule': {'nctId': 'NCT00077493', 'briefTitle': "BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma", 'nctIdAliases': ['NCT00075309'], 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas', 'orgStudyIdInfo': {'id': 'CDR0000352020'}, 'secondaryIdInfos': [{'id': 'NCI-04-C-0079H'}, {'id': 'NCI-5643'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'BL22 immunotoxin', 'interventionNames': ['Drug: BL22 immunotoxin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'antibody therapy', 'interventionNames': ['Procedure: antibody-drug conjugate therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'immunotoxin therapy', 'interventionNames': ['Procedure: immunotoxin therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'monoclonal antibody therapy', 'interventionNames': ['Procedure: monoclonal antibody therapy']}], 'interventions': [{'name': 'BL22 immunotoxin', 'type': 'DRUG', 'description': 'BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.', 'armGroupLabels': ['1']}, {'name': 'antibody-drug conjugate therapy', 'type': 'PROCEDURE', 'description': 'CD22 antibody, RFB4 on day 7', 'armGroupLabels': ['2']}, {'name': 'immunotoxin therapy', 'type': 'PROCEDURE', 'description': 'tested for immunogenicity to CAT-8015 before each cycle and at end of study.', 'armGroupLabels': ['3']}, {'name': 'monoclonal antibody therapy', 'type': 'PROCEDURE', 'description': 'administered intravenously over 30 minutes.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Alan S. Wayne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cambridge Antibody Technology', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Karen Kaucic, M.D.', 'oldOrganization': 'MedImmune Inc.'}}}}