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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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This is a phase II, multicenter study to determine the efficacy and safety of first-line lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received no prior systemic therapy.
Induction Phase (week 1 - 48):
Maintenance Phase (week 49 - progression of disease):
Response Assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all patients | Experimental | Induction Phase (week 1 - 48):
Maintenance Phase (week 49 - progression of disease):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug | Induction phase: 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day. Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression-free Survival | Secondary endpoints of progression-free survival (PFS), overall survival (OS), and time to the next treatment will be assessed by Kaplan-Meier survival analysis.PFS will be defined as the time from the first treatment day until objective or symptomatic progression or death. The outcome measure is the number of participants who achieved PFS. | 10 years |
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Inclusion Criteria:
Understand and voluntarily sign an informed consent form.
Age > = 18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with cyclin D1 overexpression by immunohistochemistry, and a characteristic immunophenotypic profile with CD5(+), CD23(-), CD20(+), and CD10(-). In tumor tissues with negative cyclin D1, evidence of cyclin D2 or D3 overexpression by immunohistochemistry will be acceptable.
No prior systemic therapy for lymphoma including chemotherapy or immunotherapy. Patients may have received involved-field radiation therapy which has been discontinued at least 4 weeks prior to treatment in this study.
Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension.
Low and intermediate-risk disease as defined by MIPI score.
Subject who the investigator considers that chemotherapy is not indicated.
ECOG performance status of < = 2 at study entry.
Laboratory test results within these ranges:
Disease free of prior malignancies for > = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or localized prostate cancer.
All subjects must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Subjects of reproductive potential agree to use birth control throughout their participation in this study, and for three months following study termination.
Females of childbearing potential (FCBP)†must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days). FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Asymptomatic carriers of hepatitis B virus can be considered for study if they agree to and comply with close monitoring and suppressive therapy with lamivudine during treatment and for additional six months after coming off study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jia Ruan, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37682791 | Derived | Yamshon S, Chen GZ, Gribbin C, Christos P, Shah B, Schuster SJ, Smith SM, Svoboda J, Furman RR, Leonard JP, Martin P, Ruan J. Nine-year follow-up of lenalidomide plus rituximab as initial treatment for mantle cell lymphoma. Blood Adv. 2023 Nov 14;7(21):6579-6588. doi: 10.1182/bloodadvances.2023010606. | |
| 30181173 | Derived |
| Label | URL |
|---|---|
| HemOnc clinical trials listing at Weill Cornell Medical College | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Study Treatment Arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Phase (Week 1- 48) |
| |||||||||||||
| Maintenance Phase (Week 49 to PD) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Study Treatment Arm |
| 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 | Overall Response Rate | The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions. | Posted | Number | 95% Confidence Interval | percentage of patients | 30 months |
|
|
The average time of Ae collection over all the patient is 6 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 | All Patients | Study Treatment Arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jia Ruan M.D, Ph.D | Weill Cornell Medicine | 646.962.2064 | amr2017@med.cornell.edu |
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| rituximab | Biological | Induction phase: Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44. Maintenance phase: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52. |
|
|
| Number of Participants With Overall Survival | Secondary endpoints of progression-free survival (PFS), overall survival (OS), and time to next treatment will be assessed by Kaplan-Meier survival analysis. Overall survival will be defined as the time from first treatment day until death. The outcome measures is the number of participants who achieved OS. | 10 years |
| Time to Next Treatment | Median amount of time (in months) from start of study treatment to next treatment | 10 years |
| Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment | 6 years |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Ruan J, Martin P, Christos P, Cerchietti L, Tam W, Shah B, Schuster SJ, Rodriguez A, Hyman D, Calvo-Vidal MN, Smith SM, Svoboda J, Furman RR, Coleman M, Leonard JP. Five-year follow-up of lenalidomide plus rituximab as initial treatment of mantle cell lymphoma. Blood. 2018 Nov 8;132(19):2016-2025. doi: 10.1182/blood-2018-07-859769. Epub 2018 Sep 4. |
| 26535512 | Derived | Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. doi: 10.1056/NEJMoa1505237. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Number of Participants With Progression-free Survival | Secondary endpoints of progression-free survival (PFS), overall survival (OS), and time to the next treatment will be assessed by Kaplan-Meier survival analysis.PFS will be defined as the time from the first treatment day until objective or symptomatic progression or death. The outcome measure is the number of participants who achieved PFS. | We enrolled a total of 38 patients (all evaluable for safety), but only 36 were evaluable for responses. Two patients could not be evaluated because they had an inflammatory syndrome ("tumor flare") during the first cycle and were withdrawn before response assessment. | Posted | Number | participants | 10 years |
|
|
|
| Secondary | Number of Participants With Overall Survival | Secondary endpoints of progression-free survival (PFS), overall survival (OS), and time to next treatment will be assessed by Kaplan-Meier survival analysis. Overall survival will be defined as the time from first treatment day until death. The outcome measures is the number of participants who achieved OS. | We enrolled a total of 38 patients (all evaluable for safety), but only 36 were evaluable for responses. Two patients could not be evaluated because they had an inflammatory syndrome ("tumor flare") during the first cycle and were withdrawn before response assessment. | Posted | Number | participants | 10 years |
|
|
|
| Secondary | Time to Next Treatment | Median amount of time (in months) from start of study treatment to next treatment | Data was not collected on this outcome measure | Posted | 10 years |
|
|
| Secondary | Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment | We enrolled a total of 38 patients (all evaluable for safety), but only 36 were evaluable for responses. Two patients could not be evaluated because they had an inflammatory syndrome ("tumor flare") during the first cycle and were withdrawn before response assessment. | Posted | Count of Participants | Participants | 6 years |
|
|
|
| 11 |
| 38 |
| 31 |
| 38 |
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cholangitis | Gastrointestinal disorders | Systematic Assessment |
|
| Melanoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Merkel Cell Carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pneumonia | General disorders | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tumor Flare | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood Bilirubin Increase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infusion Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pruritic Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Shortness of Breath | General disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood Bilirubin Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinary tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchial Infection/ Lung Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Neutropenic Fever | Blood and lymphatic system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Vomit | General disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Elevated Alanine Aminotransferase | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated Aspartate Aminotransferase | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated Alkaline Phosphatase | Hepatobiliary disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Night Sweats | General disorders | Systematic Assessment |
|
| Dyspnea | General disorders | Systematic Assessment |
|
| Sore Throat | General disorders | Systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
|
| Nasal Congestion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Macro Papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gout Flares | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Tinnitus | Nervous system disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Head Pain/Headache/Migraine | General disorders | Systematic Assessment |
|
| Rigors | General disorders | Systematic Assessment |
|
| Edema | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Tumor Flare | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infusion Related Reaction | Product Issues | Systematic Assessment |
|
| Serum Sickness | General disorders | Systematic Assessment |
|
Not provided
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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 |