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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| Celgene | INDUSTRY |
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This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).
The combination of lenalidomide with bortezomib has not been studied in patients with MCL, but feasibility and tolerability has been demonstrated in patients with multiple myeloma. Thus, almost every 2-drug combination of rituximab, lenalidomide, and bortezomib has been tested, or is being tested. We hypothesize that all three drugs are important in MCL, and therefore propose to combine all 3 agents (rituximab, bortezomib, and lenalidomide) in a schedule that is convenient to lymphoma patients.
Approximately 18 patients may be enrolled in the Phase I portion of the study. Approximately 45 patients are planned for enrollment in Phase II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab/bortezomib/lenalidomide | Experimental | Patients in Phase I & II to receive treatment with rituximab, bortezomib and lenalidomide in 21-day cycles up to 6 cycles. Phase I: Cohorts of 3 patients will be enrolled at escalating dose levels to determine the maximum tolerated dose (MTD). Doses may be de-escalated if necessary. Phase II: patients will be treated with the MTD determined in Phase I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1 Same for DL-1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants | Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03. MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab. Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash) | Collected from day of first dose to the end of the first treatment cycle, up to 21 days |
| Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II | A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study. Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6 | Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) of Phase I and Phase II Participants | Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis. |
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Inclusion Criteria:
Exclusion Criteria:
Patient has >1.5 x ULN total bilirubin.
Peripheral neuropathy ≥ CTCAE grade 2.
Relapsed or refractory patients who have received more than one prior therapy.
Pregnant or breastfeeding females. (Lactating females must agree not to breastfeed while taking lenalidomide.)
Female patients who have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable.
Thrombolic or embolic events (such as a cerebrovascular accident, including transient ischemic attacks) within the past 6 months.
Pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days of the first dose of study drug.
Any other hemorrhage/bleeding event ≥ CTCAE grade 3 ≤ 28 days of the first dose of study drug
Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
Central nervous system (CNS) involvement by lymphoma at time of enrollment.
Other medical conditions or psychiatric illness that would potentially interfere with patient participation in this trial.
A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least 2 years previously.
Previous evidence of hypersensitivity to bortezomib, boron, mannitol, thalidomide, (and development of erythema nodosum if characterized by a desquamating rash), or rituximab (true anaphylaxis, not a rituximab-infusion reaction).
Known human immunodeficiency virus (HIV) infection or chronic hepatitis A, B, or C. Patients who are HIV positive or who are positive for chronic hepatitis A, B, or C will be excluded due to increased risk for bone marrow suppression and other toxicities.
Active, clinically serious infection > CTCAE grade 2. Patients may be eligible upon resolution of the infection.
Evidence or history of bleeding diathesis or coagulopathy.
Major surgery, open biopsy, or significant traumatic injury within 28 days of the first dose of study drug.
Use of any other standard chemotherapy, radiation therapy, or experimental drug for the treatment of MCL within 28 days of starting treatment.
Any condition that impairs a patient's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease that may significantly alter the absorption of lenalidomide (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
Patients with grade 3/4 cardiac problems, as defined by the New York Heart Association (NYHA) criteria or any of the following:
Uncontrolled hypertension (systolic blood pressure [BP] > 180 or diastolic BP > 100mm Hg) or uncontrolled cardiac arrhythmias.
Any prior use of lenalidomide.
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| Name | Affiliation | Role |
|---|---|---|
| Ian W Flinn, M.D. | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Medical Group | Terre Haute | Indiana | 47802 | United States | ||
| RHHP/ Hope Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9452276 | Background | Bosch F, Lopez-Guillermo A, Campo E, Ribera JM, Conde E, Piris MA, Vallespi T, Woessner S, Montserrat E. Mantle cell lymphoma: presenting features, response to therapy, and prognostic factors. Cancer. 1998 Feb 1;82(3):567-75. doi: 10.1002/(sici)1097-0142(19980201)82:33.0.co;2-z. | |
| 17242396 | Background | Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I - Lenalidomide 15mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14. |
| FG001 | Phase I - Lenalidomide 10mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14. |
| FG002 | Phase II - Lenalidomide 10mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Based on efficacy evaluable population, all participants that received any study therapy. Participants were stratified based on phase of study (Phase I vs Phase II) and previous treatment status prior to study start (Previously Untreated vs Previously Treated (relapsed or refractory))
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I - Lenalidomide 15mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. . |
| 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 | Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants | Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03. MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab. Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash) | Includes patients that were enrolled in both lenalidomide dose levels (10 mg PO daily, 15 mg PO daily) in the Phase I portion of the study | Posted | Number | mg lenalidomide, orally, daily, day 1-14 | Collected from day of first dose to the end of the first treatment cycle, up to 21 days |
|
8 years
Time frame from the initiation of study treatment for the first patient enrolled until all patients off-treatment into the survival follow-up interval
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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 | Phase I - Lenalidomide 15mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Flinn, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bortezomib | Drug | DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11 Same for DL-1. |
|
|
| Lenalidomide | Drug | DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest |
|
|
| Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months |
| Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants | Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis. | Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months |
| Time to Best Response of Phase I and Phase II Participants | Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years |
| Time to Best Response of Previously Treated and Previously Untreated Participants | Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years |
| Duration of Response (DoR) of Phase I and Phase II Participants | Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression |
| Duration of Response (DoR) of Previously Treated and Previously Untreated Participants | Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression |
| Progression Free Survival (PFS) of Phase I and Phase II Participants | Defined as the time from entry onto study until lymphoma progression or death from any cause. Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
| Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants | Defined as the time from entry onto study until lymphoma progression or death from any cause. Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
| Overall Survival of Phase I and Phase II Participants | Defined as the date of study entry to the date of death. Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
| Overall Survival of Previously Treated and Previously Untreated Participants | Defined as the date of study entry to the date of death. Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
| Terre Haute |
| Indiana |
| 47802 |
| United States |
| St. Louis Cancer Care | Chesterfield | Missouri | 63017 | United States |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07960 | United States |
| Oncology Hematology Care Inc. | Cincinnati | Ohio | 45242 | United States |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| 10384139 | Background | Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, Kaplan G. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999 Jul 1;163(1):380-6. |
| 11418482 | Background | Davies FE, Raje N, Hideshima T, Lentzsch S, Young G, Tai YT, Lin B, Podar K, Gupta D, Chauhan D, Treon SP, Richardson PG, Schlossman RL, Morgan GJ, Muller GW, Stirling DI, Anderson KC. Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood. 2001 Jul 1;98(1):210-6. doi: 10.1182/blood.v98.1.210. |
| 15797261 | Background | Dredge K, Horsfall R, Robinson SP, Zhang LH, Lu L, Tang Y, Shirley MA, Muller G, Schafer P, Stirling D, Dalgleish AG, Bartlett JB. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005 Jan;69(1-2):56-63. doi: 10.1016/j.mvr.2005.01.002. |
| 15598978 | Background | Ghielmini M, Schmitz SF, Cogliatti S, Bertoni F, Waltzer U, Fey MF, Betticher DC, Schefer H, Pichert G, Stahel R, Ketterer N, Bargetzi M, Cerny T; Swiss Group for Clinical Cancer Research. Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol. 2005 Feb 1;23(4):705-11. doi: 10.1200/JCO.2005.04.164. Epub 2004 Dec 14. |
| 11870171 | Background | Howard OM, Gribben JG, Neuberg DS, Grossbard M, Poor C, Janicek MJ, Shipp MA. Rituximab and CHOP induction therapy for newly diagnosed mantle-cell lymphoma: molecular complete responses are not predictive of progression-free survival. J Clin Oncol. 2002 Mar 1;20(5):1288-94. doi: 10.1200/JCO.2002.20.5.1288. |
| 14563647 | Background | Kaufman DS, Lewis RL, Hanson ET, Auerbach R, Plendl J, Thomson JA. Functional endothelial cells derived from rhesus monkey embryonic stem cells. Blood. 2004 Feb 15;103(4):1325-32. doi: 10.1182/blood-2003-03-0799. Epub 2003 Oct 16. |
| 15668467 | Background | Lenz G, Dreyling M, Hoster E, Wormann B, Duhrsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. doi: 10.1200/JCO.2005.08.133. Epub 2005 Jan 24. |
| 21507715 | Background | Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, Rekhtman G, Masliak Z, Robak T, Shubina A, Arnulf B, Kropff M, Cavet J, Esseltine DL, Feng H, Girgis S, van de Velde H, Deraedt W, Harousseau JL. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40. doi: 10.1016/S1470-2045(11)70081-X. Epub 2011 Apr 18. |
| 16145068 | Background | Romaguera JE, Fayad L, Rodriguez MA, Broglio KR, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Sarris AH, Dang NH, Wang M, Beasley V, Medeiros LJ, Katz RL, Gagneja H, Samuels BI, Smith TL, Cabanillas FF. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005 Oct 1;23(28):7013-23. doi: 10.1200/JCO.2005.01.1825. Epub 2005 Sep 6. |
| 3555648 | Background | Weisenburger DD, Sanger WG, Armitage JO, Purtilo DT. Intermediate lymphocytic lymphoma: immunophenotypic and cytogenetic findings. Blood. 1987 Jun;69(6):1617-21. |
| 10637245 | Background | Foran JM, Rohatiner AZ, Cunningham D, Popescu RA, Solal-Celigny P, Ghielmini M, Coiffier B, Johnson PW, Gisselbrecht C, Reyes F, Radford JA, Bessell EM, Souleau B, Benzohra A, Lister TA. European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma. J Clin Oncol. 2000 Jan;18(2):317-24. doi: 10.1200/JCO.2000.18.2.317. |
| 12649301 | Background | Schafer PH, Gandhi AK, Loveland MA, Chen RS, Man HW, Schnetkamp PP, Wolbring G, Govinda S, Corral LG, Payvandi F, Muller GW, Stirling DI. Enhancement of cytokine production and AP-1 transcriptional activity in T cells by thalidomide-related immunomodulatory drugs. J Pharmacol Exp Ther. 2003 Jun;305(3):1222-32. doi: 10.1124/jpet.102.048496. Epub 2003 Mar 20. |
| Disease Progression |
|
| BG001 | Phase I - Lenalidomide 10mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. |
| BG002 | Phase II - Lenalidomide 10mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex/Gender, Customized | Gender based on participants' previous treatment prior to initiating study treatment (previously treated and previously untreated) | Count of Participants | Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous Treatment for Mantle Cell Lymphoma (MCL) | Includes participants with relapsed or refractory MCL who have received one previous treatment prior to starting study treatment, and those with previously untreated MCL prior to starting study treatment. | Number | participants |
|
Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14. Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants) |
|
|
| Primary | Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II | A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study. Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6 | Includes patients that were enrolled in the Phase II section of the study | Posted | Number | participants | Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment |
|
|
|
| Secondary | Overall Response Rate (ORR) of Phase I and Phase II Participants | Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis. | The efficacy evaluable population (all participants who have received any study treatment) | Posted | Count of Participants | Participants | Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months |
|
|
|
| Secondary | Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants | Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis. | The efficacy evaluable population (all participants who have received any study treatment) | Posted | Count of Participants | Participants | Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months |
|
|
|
| Secondary | Time to Best Response of Phase I and Phase II Participants | Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | All participants that received study treatment that were evaluable for a response assessment (one participant in Phase I and two participants in Phase II were considered unevaluable, discontinuing prior to first post-baseline response assessment) | Posted | Median | Full Range | days | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years |
|
|
|
| Secondary | Time to Best Response of Previously Treated and Previously Untreated Participants | Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. | All patients that received study treatment that were evaluable for a response assessment (2 previously untreated participants and 1 previously treated participant were considered unevaluable, discontinuing prior to first post-baseline response assessment) | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years |
|
|
|
| Secondary | Duration of Response (DoR) of Phase I and Phase II Participants | Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | All participants that received study treatment that were responders (achieved a PR or better) | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression |
|
|
|
| Secondary | Duration of Response (DoR) of Previously Treated and Previously Untreated Participants | Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement. | All participants that received study treatment that were responders (achieved a PR or better) | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression |
|
|
|
| Secondary | Progression Free Survival (PFS) of Phase I and Phase II Participants | Defined as the time from entry onto study until lymphoma progression or death from any cause. Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | All participants that received study treatment | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
|
|
|
| Secondary | Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants | Defined as the time from entry onto study until lymphoma progression or death from any cause. Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification. | All participants that received study treatment | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
|
|
|
| Secondary | Overall Survival of Phase I and Phase II Participants | Defined as the date of study entry to the date of death. Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification | all participants that received study treatment | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
|
|
|
| Secondary | Overall Survival of Previously Treated and Previously Untreated Participants | Defined as the date of study entry to the date of death. Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification | all participants that received study treatment | Posted | Median | 95% Confidence Interval | months | Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression |
|
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| EG001 | Phase I - Lenalidomide 10mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. | 6 | 8 | 8 | 8 |
| EG002 | Phase II - Lenalidomide 10mg PO QD | Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. | 13 | 26 | 25 | 26 |
| Acute Renal Failure | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Cardiac Ischemia/Infarction | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Clostridium Difficile | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Death | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Gastrointestinal- Intussusception | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Infection- Lung (Pneumonia) | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Infection- Pyelonephritis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Infection- Septic Shock | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Infection- Varicella | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Infection- Viral Syndrome | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Mental Status Change | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Opioid Withdrawal | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Pain- Non Cardiac Chest | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Pain- NOS | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Platelet Count Decreased | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Secondary Malignancy- Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| ALKALINE PHOSPHATASE INCREASED | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| ALLERGIC REACTION | Immune system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ALLERGIC REACTION (INSECT BITE) | Immune system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| ASTHENIA | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| BENIGN PROSTATE HYPERPLASIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| BLURRED VISION | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| CHEST CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| CHEST PAIN | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| CHILLS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| CREATININE LEVELS DECREASED | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DIABETES | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| EDEMA | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ESOPHAGITIS | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| EYELID DYSFUNCTION | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| FEVER | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HEART FAILURE | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HEMATOCRIT DECREASED | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| HOT FLASHES | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERBILIRUBINEMIA | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERNATREMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOTHERMIA | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| INSOMNIA | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| INVOLUNTARY MOVEMENTS | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| MOOD ALTERATION | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| MUCOSITIS | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NASAL DRAINAGE | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NEURALGIA | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PERIPHERAL NEUROPATHY | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PROTEINURIA | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SINUS INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SORE THROAT | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SPLENOMEGALY | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| STOMACH PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| TASTE ALTERATION | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| TREMOR | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| URINARY TRACT PAIN | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| URINE DISCOLORATION | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| VAGINAL INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| VISION CHANGE | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| WATERING EYES | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| WEIGHT LOSS | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Leukopenia |
|
| Nausea |
|
| Diarrhea |
|
| Edema |
|
| Hyperglycemia |
|
| Peripheral Neuropathy |
|
| Neutropenia |
|
| Hypoalbuminemia |
|
| Constipation |
|
| Hypocalcemia |
|
| Pain in Extremity |
|
| Anemia |
|
| Cough |
|
| Fever |
|
| Dehydration |
|
| Pruritus |
|
| Dyspnea |
|
| Hyponatremia |
|
| Insomnia |
|
| Abdominal Pain |
|
| Dizziness |
|
| Hypokalemia |
|
| Weight Loss |
|
| Anorexia |
|
| Erythema |
|
| Hypomagnesemia |
|
| Allergic Reaction |
|
| Chills |
|
| Hyperhidrosis |
|
| Myalgia |
|
| Headache |
|
| Mucositis |
|
| Hypoglycemia |
|