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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Screening Log

- 7/10/18 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Screening Procedure, Administrative Documentation
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Laboratory Reference Ranges

- 7/10/18 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data, Hematology, Other Parameters, Chemistry, Thyroid Parameters
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin Complete this form for each clinical lab for which data are reported on case report forms. For data reported from outside institutions, please obtain the reference ranges and lab certification documentation. Use same Lab ID number on all laboratory forms. The form only needs to be completed once for each lab unless ranges or units change.

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Patient Enrollment

- 7/10/18 - 1 form, 11 itemgroups, 39 items, 1 language
Itemgroups: Demographics, Lymphoid Neoplasms; Inclusion Criteria, CD20 antigen; Inclusion Criteria, Prior chemotherapy; Inclusion Criteria, Karnofsky Performance Status; Survival time, Anticipated; Inclusion Criteria, ANC; Platelet Count; Inclusion Criteria, Renal function; Hepatic function; Inclusion Criteria, Bi-dimensionally measured disease; Inclusion Criteria, Age; Inclusion Criteria, Informed Consent; Inclusion Criteria, Exclusion criteria
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Laboratory Identification Log

- 7/10/18 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Laboratory Identification
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Long-Term Follow-Up for Survival & Disease Status

- 7/10/18 - 1 form, 7 itemgroups, 23 items, 1 language
Itemgroups: Administrative Data, Additional therapy for NHL since the last LTFU, Myelodysplasia, AML, Malignancy, TSH measurement, HAMA
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin This form is to be completed every 6 months once the patient has entered long-term follow-up.

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Long-Term Follow-Up for Survival & Disease Status

- 6/25/18 - 1 form, 7 itemgroups, 23 items, 1 language
Itemgroups: Default Itemgroup, Additional therapy for NHL since the last LTFU, Myelodysplasia, AML, Malignancy, TSH measurement, HAMA
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin This form is to be completed every 6 months once the patient has entered long-term follow-up.

29959_Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy - General Medical History, Physical Examination Baseline

- 5/15/18 - 1 form, 6 itemgroups, 25 items, 1 language
Itemgroups: Administration, Medical History Date, Demographics, Diagnosis/Condition, Physical Examination - Baseline, Physical Examination
https://clinicaltrials.gov/show/NCT00989664 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Laboratory GOAL Trial B-cell Lymphoma NCT02499003

- 1/4/18 - 1 form, 3 itemgroups, 123 items, 1 language
Itemgroups: Admininstrative data, Laboratory Hematology, Laboratory Blood chemistry
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

- 1/4/18 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Admininstrative data, Exclusion criteria
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Screening Registration GOAL Trial B-cell Lymphoma NCT02499003

- 1/4/18 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Admininstrative data, Registration
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Signature GOAL Trial B-cell Lymphoma NCT02499003

- 1/4/18 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Admininstrative data, Signature
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Visit: All Visits Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

- 1/4/18 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Admininstrative data, Inclusion Criteria
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

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