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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
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This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VELCADE and fludarabine (Group A) | Experimental | VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle |
|
| fludarabine and rituximab (Group B) | Active Comparator | fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludarabine | Drug | fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary. | Up to 8 cycles (1 cycle is 35 days: 280 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary. | Up to 8 cycles (1 cycle is 35 days: 280 days) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with histological or clinical transformation to an aggressive lymphoma
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Amiens | 80054 | France | |||
| Institut Bergonie |
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| ID | Title | Description |
|---|---|---|
| FG000 | Velcade + Fludarabine | |
| FG001 | Rituximab + Fludarabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| rituximab | Drug | rituximab 375mg/m2 on Day 1 of every 35-day cycle |
|
| VELCADE | Drug | 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle |
|
| Bordeaux |
| 33076 |
| France |
| CHU Hotel Dieu | Clermont-Ferrand | 63000 | France |
| Centre Victor Hugo | Le Mans | 72000 | France |
| CHU Caremeau | Nîmes | 30029 | France |
| Hoptial Saint Louis | Paris Cedex 10, 75 | 75475 | France |
| Hopital Cochin | Paris, 75, Cedex 14 | 75679 | France |
| Klinikum Bamberg, fachbereich 3 | Bamberg | BY 96049 | Germany |
| Charite, group Benjamin Franklin | Berlin | BE 12203 | Germany |
| Hospital Spandau | Berlin | BE 13585 | Germany |
| Vivantes Klinikum am Urban | Berlin, BE | 10967 | Germany |
| Universitaetsklinikum Frankfurt | Frankfurt | HE 60590 | Germany |
| Universitatsklinikum Gottingen, zentrum Innere medicin | Göttingen | NI 37075 | Germany |
| Evangelisches Krankenhaus Hamm | Hamm | NW 50063 | Germany |
| Klinikum Idar-Oberstein GmbH | Idar-Oberstein | RP 55743 | Germany |
| Universitaetsklinikum Jena | Jena | TH 07740 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | SN 04103 | Germany |
| Universitaetsklinikum Mainz | Mainz | 55131 | Germany |
| Robert Bosch Krankenhaus | Stuttgart | BW 70376 | Germany |
| Mutterhaus der Borromaeerinnen | Trier | RP 54290 | Germany |
| Universitatsklinikum Ulm | Ulm | BW 89081 | Germany |
| Klinikum der Stadt Villinger-Schwenningen | Villingen-Schwenningen | 78050 | Germany |
| Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine | Athens | 11527 | Greece |
| University Hospital of Heraklion- Department of Hematology | Heraklion- Crete | 71110 | Greece |
| Haemek Medical Center - Hematology Department | Afula | 18101 | Israel |
| Rambam Med.Center - Hematology Institute | Haifa | 31096 | Israel |
| Hadassah University Hospital - Hematology Department | Jerusalem | 91120 | Israel |
| Rabin Medical Center - Hematology Institute | Petah Tikva | 49100 | Israel |
| Sheba MC - Hematology Institute | Ramat Gan | 52621 | Israel |
| Policlinico di Bari | Bari | Italy |
| Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi | Bologna | Italy |
| Clinica di Ematologia DIMI - A.O. Ospedale S. Martino | Genova | Italy |
| Ospedale Niguarda Ca' Granda | Milan | Italy |
| Azienda Ospedaliera Antonio Cardarelli | Naples | Italy |
| Ospedale Policlinico San Matteo Irccs | Pavia | Italy |
| A.O.Univ.Pisana-Osp. Santa Chiara | Pisa | Italy |
| Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6 | Roma | 00161 | Italy |
| Azienda Ospedaliera Santa Maria di Terni | Terni | Italy |
| Divisione di Ematologia Ospedale San Bortolo - Hematology | Vicenza | Italy |
| Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta | Cadiz | 11009 | Spain |
| Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta | Murcia | 30008 | Spain |
| Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta | Salamanca | 37007 | Spain |
| Kantonsspital St.Gallen Department of Oncology/Hematology | Sankt Gallen | 9007 | Switzerland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Velcade + Fludarabine | |
| BG001 | Rituximab + Fludarabine | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response Rate | The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary. | Received at least one dose of study drug | Posted | Number | participants | Up to 8 cycles (1 cycle is 35 days: 280 days) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary. | Received at least one dose of study drug | Posted | Number | participants | Up to 8 cycles (1 cycle is 35 days: 280 days) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Velcade + Fludarabine | 2 | 4 | 4 | 4 | |||
| EG001 | Rituximab + Fludarabine | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Small Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| General physical health deterioration | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Respiratory gas exchange disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blepharitis | Eye disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Performance status decreased | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Tinea infection | Infections and infestations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Conversion disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Early termination leading to small numbers of subjects analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Cakana, MD, FRC Path | Johnson & Johnson Pharmaceutical Research & Development | [ACAKANA@ITS.JNJ.COM |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Male |
|
| Greece |
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| Spain |
|
| Israel |
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| Germany |
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| Switzerland |
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| Italy |
|
|