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Primary Objective
1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).
Secondary Objectives
Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles
Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)
Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment
Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment Arm | Experimental | Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 15 mg/kg on day 1 of each of 6 cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Toxicity | Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. | 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate measured using Kaplan-Meier survival analysis Response criteria were those reported by Cheson et al. (1999) | 38 Months (min 33 months, max 62 months) |
| Progression-Free Survival |
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Inclusion Criteria:
Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin > 7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Leonard, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Weill Medical College of Cornell University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Treatment Arm | Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Treatment Arm | Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles |
| 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 | Number of Participants With Toxicity | Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. | Posted | Number | participants | 38 months |
|
|
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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 | Study Treatment Arm | Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate Cancer | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Leonard, MD | Weill Cornell Medicine | 646.962.2064 | amr2017@med.cornell.edu |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rituximab |
| Drug |
Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles. The dose to be administered is: Rituximab: 375 mg/m2 |
|
| CHOP | Drug | Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7 |
|
The percentage of patients who have not progressed at the three year time point.
The 3-year PFS rate was estimated based on the Kaplan-Meier analysis.
| 3 years |
| Overall Survival | The percentage of patients who have survived at the three year time point. The 3-year OS rate was estimated based on the Kaplan-Meier analysis. | 3 years |
| New York |
| New York |
| 10021 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Response Rate | Overall Response Rate measured using Kaplan-Meier survival analysis Response criteria were those reported by Cheson et al. (1999) | Evaluable patients | Posted | Number | 95% Confidence Interval | percentage of participants | 38 Months (min 33 months, max 62 months) |
|
|
|
| Secondary | Progression-Free Survival | The percentage of patients who have not progressed at the three year time point. The 3-year PFS rate was estimated based on the Kaplan-Meier analysis. | Evaluable patients | Posted | Number | 95% Confidence Interval | percentage of patients | 3 years |
|
|
|
| Secondary | Overall Survival | The percentage of patients who have survived at the three year time point. The 3-year OS rate was estimated based on the Kaplan-Meier analysis. | Evaluable Patients | Posted | Number | 95% Confidence Interval | percentage of patients | 3 years |
|
|
|
| 1 |
| 11 |
| 11 |
| 11 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Febrile Neutropenia | Infections and infestations | Systematic Assessment |
|
| Infection (normal ANC) | Infections and infestations | Systematic Assessment |
|
| Left ventricular systolic dysfunction | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Bleeding | General disorders | Systematic Assessment |
|
| Rituximab infusion rxn | Infections and infestations | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hypocalcemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Constipation | General disorders | Systematic Assessment |
|
| Edema | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Second malignancy | General disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Mouth sore | General disorders | Systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypoalbuminemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Dyspnea | General disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |