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| ID | Type | Description | Link |
|---|---|---|---|
| 8785 | Other Identifier | DUMC old IRB number |
Not provided
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Low accrual.
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.
This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF.
All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-FND | Experimental | Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete and Partial Response |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response is measured from time of treatment to time of disease progression | up to 4 years |
| Percentage of Subjects Experiencing Progression Free Survival | Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Rizzieri, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Of the 14 subjects consented, 2 were screen failures so only 12 subjects received the study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | VR-FND | Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who were consented are included in the baseline analysis population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VR-FND | Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 and Partial Response |
| Posted | Number | percentage of participants | 1 year |
|
From first dose of study drug to 30 days after the last dose of study drug
All adverse events are reported whether or not they are considered attributable to the study treatment.
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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 | VR-FND | Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood / Bone Marrow - Other | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Rizzieri | Duke University Medical Center | 919-668-1000 | rizzi003@mc.duke.edu |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| C024352 | fludarabine |
| D008942 | Mitoxantrone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
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| Rituximab | Drug | Rituximab 375 mg/m2 IV on day 1 |
|
| Fludarabine | Drug | Fludarabine 25 mg/m2 IV on days 1,2,3 |
|
| Mitoxantrone | Drug | Mitoxantrone 10 mg/m2 IV on day 2 |
|
|
| Dexamethasone | Drug | Dexamethasone 20 mg orally on days 1,2,3,4,5 |
|
| up to 2 years |
| Percentage of Subjects Experiencing Overall Survival | Overall survival is from the day of enrollment to date of death from any cause. | up to 2 years |
| Number of Participants With a Grade 3-4 Hematologic Toxicity. | Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC). | up to 1 year |
| Number of Participants With Neuropathy, Any Grade | Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC). | up to 1 year |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Duration of Response | Duration of response is measured from time of treatment to time of disease progression | Posted | Mean | Full Range | months | up to 4 years |
|
|
|
| Secondary | Percentage of Subjects Experiencing Progression Free Survival | Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment. | Posted | Number | percentage of participants | up to 2 years |
|
|
|
| Secondary | Percentage of Subjects Experiencing Overall Survival | Overall survival is from the day of enrollment to date of death from any cause. | Posted | Number | percentage of participants | up to 2 years |
|
|
|
| Secondary | Number of Participants With a Grade 3-4 Hematologic Toxicity. | Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC). | Posted | Number | participants | up to 1 year |
|
|
|
| Secondary | Number of Participants With Neuropathy, Any Grade | Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC). | Posted | Number | participants | up to 1 year |
|
|
|
| 0 |
| 12 |
| 12 |
| 12 |
| Febrile neutropenia (fever of unknown origin without documented infection) | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Low Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Auditory / Ear | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vision - blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry mouth / salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Heartburn / dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis / Stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Anus | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Dental / teeth / peridontal | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constitutional Symptoms - Other | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema: head and neck | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema: limb | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Chest / thorax NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rigors / chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Gallbladder | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infection - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Infection with unknown ANC - Mucosa | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| High Alkaline phosphatase | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| High AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| High Creatinine | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Low Leukocytes (total WBC) | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Metabolic / Laboratory - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Low Neutrophils / granulocytes (ANC / AGC) | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Low Platelets | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Uric Acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Musculoskeletal - Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neuropathy: motor | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Head / headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Taste Alteration (dysgeusia) | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mood Alteration - Agitation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Kidney | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal / Genitourinary - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain - Throat / pharynx / larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Petechiae / purpura (hemorrhage / bleeding into skin or mucosa) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pruritus / itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash / desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| 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 |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |