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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (CR + PR) | Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. | From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Garbo, MD | US Oncology Research | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemzar + Novantrone + Rituxan | Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemzar + Novantrone + Rituxan | Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Objective Response Rate (CR + PR) | Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. | Evaluable Population | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
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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 | Gemzar + Novantrone + Rituxan | Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CACHEXIA | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDO ENLARGE | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence E. Garbo | New York Oncology Hematology | (518) 489-0044 | Lawrence.Garbo@usoncology.com |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D008942 | Mitoxantrone |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| mitoxantrone | Drug | Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan. |
|
|
| rituximab | Drug | Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan. |
|
|
| Overall Survival (OS) Rate at 1 Year | OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. | 1 year. |
| Progression-free Survival Rate at 1 Year. | PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. | 1 year. |
| Investigator Request |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Duration of Response | The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. | For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response. | Posted | Median | Full Range | months | From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months. |
|
|
|
| Secondary | Overall Survival (OS) Rate at 1 Year | OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. | ITT population | Posted | Number | 95% Confidence Interval | Probability of Survival | 1 year. |
|
|
|
| Secondary | Progression-free Survival Rate at 1 Year. | PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. | ITT population | Posted | Number | 95% Confidence Interval | Probability of Progression-free Survival | 1 year. |
|
|
|
| 4 |
| 15 |
| 15 |
| 15 |
| FEVER | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN ABDO | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ALLERG REACT | Immune system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ANOREXIA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| BILIRUBINEM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| BUN INC | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| CHILLS | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| CONSTIP | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| COUGH INC | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| CREATININE INC | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DEHYDRAT | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DEPRESSION | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| EDEMA PERIPH | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| FEVER | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| FLATUL | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| FLU SYND | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HEADACHE | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HEMATURIA | Renal and urinary disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HYPERGLYCEM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HYPERURICEM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HYPOCALCEM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HYPONATREM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HYPOPROTEINEM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HYPOVOLEM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| INFECT | Infections and infestations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| INSOMNIA | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| LAB TEST ABNORM | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| LDH INC | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| MUCOUS MEM DIS | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN ABDO | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN BONE | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN CHEST SUBSTERN | Investigations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PALLOR | Investigations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PHOSPHATASE ALK INC | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PLAT ABNORM | Investigations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| RECTAL DIS | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| RHINITIS | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| STOMATITIS | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| SWEAT | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| TASTE PERVERS | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| THROMBOCYTHEM | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| VASODILAT | Investigations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| VOMIT | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| WEIGHT DEC | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
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| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| 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 |