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| ID | Type | Description | Link |
|---|---|---|---|
| CALACASS-3RCHOPZ | |||
| INCA-RECF0624 | |||
| 2006-006179-19 | EudraCT Number | ||
| CALACASS-2006/27 |
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RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP14 chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological |
| ||
| cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 2 years | |
| Relapse-free Survival in Responding Patients | 2 years | |
| Response Rate at the End of Treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed large B-cell lymphoma
CD20-positive disease
Measurable disease
No prior indolent lymphoma, treated or not
No meningeal or CNS lymphoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Frederec Peyrade, MD | Centre Antoine Lacassagne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06189 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | R-CHOP14 Chemotherapy | rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate yttrium Y 90 ibritumomab tiuxetan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| R-CHOP14 Chemotherapy |
|
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| doxorubicin hydrochloride | Drug |
|
| prednisone | Drug |
|
| vincristine sulfate | Drug |
|
| yttrium Y 90 ibritumomab tiuxetan | Radiation |
|
Complete Response 60% (N=15) Partial Response 8% (N=2) Missing data 32% (N=8) |
| up to six months |
| COMPLETED |
|
| NOT COMPLETED |
|
| Follow up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | R-CHOP14 Chemotherapy | rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate yttrium Y 90 ibritumomab tiuxetan |
| 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 |
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| 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 | Event-free Survival | Posted | Number | 95% Confidence Interval | percentage of patient | 2 years |
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| Secondary | Overall Survival | Posted | Number | 95% Confidence Interval | percentage of patient | 2 years |
|
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| |||||||||||||||||||||||||||
| Secondary | Relapse-free Survival in Responding Patients | Posted | Number | 95% Confidence Interval | percentage of patient | 2 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Response Rate at the End of Treatment | Complete Response 60% (N=15) Partial Response 8% (N=2) Missing data 32% (N=8) | Patients who completed the full course of treatment | Posted | Count of Participants | Participants | up to six months |
|
|
2 years
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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 | R-CHOP14 Chemotherapy | rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate yttrium Y 90 ibritumomab tiuxetan | 10 | 30 | 28 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| SEVERE PULMONARY INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| APLASIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| FEBRILE APLASIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| RENAL INSUFFICIENCY | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| FAINTNESS WITH LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| THROMBOPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| MUCOSITIS | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| IMPAIRMENT OF HEALTH STATUS | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| FACE PARALYSIS | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| RESPIRATORY INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Iodine allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Centre Antoine Lacassagne | +33 4 92 03 10 00 | DRCI-Promotion@nice.unicancer.fr |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| 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 |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| C422802 | ibritumomab tiuxetan |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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| Title | Denominators | Categories | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|