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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | Experimental | Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VELCADE® | Drug | 1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. | Percentage of complete responders plus percentage of partial responders equals overall response rate. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadi Nabhan, MD | Oncology Specialists, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onocology Specialists, S.C | Niles | Illinois | 60714 | United States | ||
| Oncology Specialists, S.C |
Eligible pts had LG-NHL requiring treatment. Mantel cell NHL pts who were'nt transplant eligible and MALToma pts who failed RT and antibiotics were allowed.
Rituximab (R) are alone or R based chemo programs are front line approach LG-NHL pts requiring therapy. Identifying programs that are effective in the elderly pts is challenging. These pts were recruited in our private practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Velcade, Rituximab,Cyclophosphamide & Decadron | Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Velcade, Rituximab,Cyclophosphamide & Decadron | Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. |
| 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 |
| 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 | Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. | Percentage of complete responders plus percentage of partial responders equals overall response rate. | 1 pt withdrew before completing two cycles and was not evaluable for OS. | Posted | Number | percentage of patients | 4 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 | Velcade, Rituximab,Cyclophosphamide & Decadron | Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety Grade 1 & 2 | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sigrun Hallmeyer, MD Director of Research | Oncology Specialists SC | 847-268-8200 | shallmeyer@oncmed.net |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Rituximab | Drug | 375 mg/m^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. |
|
|
| Cyclophosphamide | Drug | 400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle. |
|
|
| Decadron | Drug | 40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23 |
|
|
| Park Ridge |
| Illinois |
| 60068 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival | The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%. | Posted | Number | percentage of participants | 4 years |
|
|
|
| 2 |
| 12 |
| 12 |
| 12 |
| Cerebral Vascular Accident | Nervous system disorders |
|
| Abdominal Pain Grade 1 & 2 | Gastrointestinal disorders |
|
| Appetite Decreased Grade 1 & 2 | Gastrointestinal disorders |
|
| Bilirubin Increased Grade 1 & 2 | Renal and urinary disorders |
|
| Alopecia Grade 1 & 2 | General disorders |
|
| Creatinine Increased Grade 1 & 2 | Renal and urinary disorders |
|
| Constipation Grade 1 & 2 | Gastrointestinal disorders |
|
| Cough Grade 1 & 2 | Respiratory, thoracic and mediastinal disorders |
|
| Chills Grade 1 & 2 | General disorders |
|
| Edema Grade 1 & 2 | General disorders |
|
| Fever Grade 1 & 2 | General disorders |
|
| Fatigue Grade 1 & 2 | General disorders |
|
| Hyponatremia Grade 1 & 2 | Gastrointestinal disorders |
|
| Hypertension Grade 1 & 2 | Cardiac disorders |
|
| Hyperglycemia Grade 1 & 2 | Gastrointestinal disorders |
|
| Insomnia Grade 1 & 2 | General disorders |
|
| Leukopenia Grade 1 & 2 | Blood and lymphatic system disorders |
|
| Rash Grade 1 & 2 | Skin and subcutaneous tissue disorders |
|
| Nausea Grade 1 & 2 | Gastrointestinal disorders |
|
| Mucositis Grade 1 & 2 | Gastrointestinal disorders |
|
| Pulmonary Edema Grade 1 & 2 | Respiratory, thoracic and mediastinal disorders |
|
| Nail Changes Grade 1 & 2 | Skin and subcutaneous tissue disorders |
|
| Sweats Grade 1 & 2 | General disorders |
|
| Dry Skin Grade 1 & 2 | Skin and subcutaneous tissue disorders |
|
| Stomatitis Grade 1 & 2 | Gastrointestinal disorders |
|
| Sinus Congestion Grade 1 & 2 | Respiratory, thoracic and mediastinal disorders |
|
| Tronopin Increased Grade 1 & 2 | Blood and lymphatic system disorders |
|
| Triglyceride Increased Grade 1 & 2 | General disorders |
|
| Tongue Swelling Grade 1 & 2 | General disorders |
|
| Weight Decreased Grade 1 & 2 | Gastrointestinal disorders |
|
| Tooth Abcess Grade 1 & 2 | General disorders |
|
| Vomiting Grade 1 & 2 | Gastrointestinal disorders |
|
| Difficulty Walking Grade 1 & 2 | Musculoskeletal and connective tissue disorders |
|
| Chest Pain Grade 3 & 4 | Musculoskeletal and connective tissue disorders |
|
| Hyperglycemia Grade 3 & 4 | Gastrointestinal disorders |
|
| Leukopenia Grade 3 & 4 | Blood and lymphatic system disorders |
|
| Neutropenia Grade 3 & 4 | Blood and lymphatic system disorders |
|
| Orthopnea Grade 3 & 4 | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Edema Grade 3 & 4 | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Emboli Grade 3 & 4 | Respiratory, thoracic and mediastinal disorders |
|
| Shortness of Breath Grade 3 & 4 | Respiratory, thoracic and mediastinal disorders |
|
| Headache Grade 1 & 2 | General disorders |
|
| Pain Grade 1 & 2 | General disorders |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |