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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2005133 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20060249 | Other Identifier | Western Institutional Review Board |
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Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zevalin + Rituximab | Experimental | Ibritumomab Tiuxetan (Zevalin) + Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. | The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy. | 12 weeks post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Progression-Free Survival | The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier. | End of study. |
| 5-Year Rate of Progression-Free Survival (5-Year PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Izidore S. Lossos, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25315074 | Background | Lossos IS, Fabregas JC, Koru-Sengul T, Miao F, Goodman D, Serafini AN, Hosein PJ, Stefanovic A, Rosenblatt JD, Hoffman JE. Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1750-5. doi: 10.3109/10428194.2014.975801. Epub 2014 Nov 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zevalin + Rituximab | Ibritumomab Tiuxetan (Zevalin) + Rituximab Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data reported for only 16 of 18 participants due to 2 participants withdrawing consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zevalin + Rituximab | Ibritumomab Tiuxetan (Zevalin) + Rituximab Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ |
| 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 Rate of Response (ORR) in Participants Receiving Protocol Therapy. | The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy. | Posted | Number | 90% Confidence Interval | percentage of participants | 12 weeks post-therapy |
|
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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 | Zevalin + Rituximab | Ibritumomab Tiuxetan (Zevalin) + Rituximab Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection (Grade 3) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain (Grade 1-2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Data reported for only 16 of 18 enrolled participants due to 2 participants withdrawing consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Izidore S. Lossos | University of Miami | 305-243-4785 | ilossos@med.miami.edu |
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| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| Ibritumomab Tiuxetan | Drug | IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ |
|
|
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation. |
| 5 Years |
| Overall Survival (OS) Rate | The time from the date of initiation of study treatment until date of death from any cause for all participants. | End of Study |
| 5 Year Rate of Overall Survival (5-Year OS) | Percentage of participants still alive five years after the date of protocol therapy initiation. | 5 Years |
| Number of Participants With Unacceptable Toxicity. | Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events. | Up to 12 weeks post-therapy |
| years |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Data reported for only 16 of 18 participants due to 2 participants withdrawing consent. | Count of Participants | Participants |
|
| Disease Stage | Number of participants grouped by extent (reach) and location of the lymphoma at Baseline: Stage I, Stage II, Stage III and Stage IV. The stage depends on both the place where the malignant tissue is located and on systemic symptoms due to the lymphoma ("B symptoms": night sweats, weight loss of >10% or fevers).The higher the stage number, the larger the extent of the lymphoma, and/or the more it has grown into nearby tissues. | Number | participants |
|
| Extranodal disease sites | Number of participants grouped by the number of sites outside of the lymph nodes where lymphoma is present at baseline. | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Number of participants grouped according to their Eastern Cooperative Oncology Group (ECOG) performance status or score at baseline. The ECOG score attempts to quantify patients' general well being and level of activities of daily life. The higher the score, the less healthy the patient's general well being and lower the the patient's level of the daily activity. | Number | participants |
|
| Bone Marrow involvement | Number of participants grouped by the presence of lymphoma cells in the bone marrow at baseline. | Number | participants |
|
| Lactate dehydrogenase (LDH) Levels | Number of participants grouped by serum levels of LDH at baseline. | Number | participants |
|
| Bulky disease (cm) | Number of patients grouped by the size of large tumors or lymph nodes in centimeters (cm) present at baseline. | Number | participants |
|
| International Prognostic Index (IPI) Risk Group | Number of participants grouped by their prognosis with aggressive non-Hodgkin's lymphoma. One point is assigned for each of the following risk factors:
The sum of the points allotted correlates with the following risk groups:
| Number | participants |
|
| Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group | Number of participants grouped by their prognosis with follicular lymphoma. One point is assigned for each of the following factors:
The sum of the points allotted correlates with the following risk groups:
| Number | participants |
|
|
|
| Secondary | Rate of Progression-Free Survival | The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier. | Posted | Median | Full Range | months | End of study. |
|
|
|
| Secondary | 5-Year Rate of Progression-Free Survival (5-Year PFS) | Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation. | Posted | Number | 90% Confidence Interval | percentage of participants | 5 Years |
|
|
|
| Secondary | Overall Survival (OS) Rate | The time from the date of initiation of study treatment until date of death from any cause for all participants. | Median overall survival by Kaplan-Meier method for all patients was not attained. | Posted | Number | months | End of Study |
|
|
|
| Secondary | 5 Year Rate of Overall Survival (5-Year OS) | Percentage of participants still alive five years after the date of protocol therapy initiation. | Posted | Number | 90% Confidence Interval | percentage of participants | 5 Years |
|
|
|
| Secondary | Number of Participants With Unacceptable Toxicity. | Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events. | Posted | Number | participants | Up to 12 weeks post-therapy |
|
|
|
| 2 |
| 16 |
| 15 |
| 16 |
| Fatigue (Grade 3) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal Pain (Grade 3) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sepsis (Grade 5) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic Reaction | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limbs | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hepatic infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection, Skin (cellulites) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection, Upper airway NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Metabolic/Lab - Other(Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myelodysplasia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuralgia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Petechiae | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| PTT | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rhinitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/embolism (vascular access) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tooth disorder | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| 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 |