Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg

Ibritumomab tiuxetan

Canales Miguel, Dr

Lopez-Guillermo Armando, Dr

Tomas Jose Francisco, Dr

After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:

A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.

The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity

ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

GELCAB

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

PETHEMA Foundation

Lymphoma, Follicular

Lymphoma, Non-Hodgkin

Follicular Lymphoma

Orbital Lymphoma

Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.

250 mg/m\^2 IV over 4-6 hours for 2 weeks.

5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.

Zevalin

Bita Esmaeli, MD

Primary Objectives:

1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
2. To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
3. To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.

Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell death.

As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed to confirm the diagnosis and status of the orbital lymphoma. The study doctors must first make sure that the disease has not spread too much and is not severe enough to require immediate treatment with chemotherapy before you can begin treatment on this study. You will have about 4 teaspoons of blood drawn. Women who are able to have children must have a negative blood or urine pregnancy test.

You will receive two injections of rituximab by vein over about 4 to 6 hours. This is followed by an infusion of Zevalin over about 30 minutes on the same day. Whole body images will be performed immediately and at 4-6, 24, 72, and 144 hours after receiving Zevalin. About 1 week later, you will receive a second infusion of rituximab and Zevalin.

You may be taken off the study if your orbital lymphoma does not respond within three months of receiving rituximab and Zevalin. Researchers will measure your response to therapy using magnetic Resonance imaging (MRI) of the orbit and an evaluation of the eye in the clinic. If you are taken off study, you will be given the option of receiving external beam radiation therapy as treatment for the disease.

Follow-up evaluations will be done every 3 months for 2 years and every 6 months for Years 3 and 4. This testing is considered standard of care and would include medical history, physical exam, blood tests, and urine tests. The status of the disease will be evaluated using CT scan or MRI of the orbit every 3 months for the first year and every 6 months for Years 2, 3, and 4. Blood tests (about 4 teaspoons each) will be every 3 months for the first year and may be continues every 3 to 6 month until they become negative or you start another anti-cancer therapy.

This is an investigational study. Zevalin and rituximab are both FDA approved but their use together in this study is investigational. A total of up to 12 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.

Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma

Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva

Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.

Biogen

M.D. Anderson Cancer Center

Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.

Zevalin + Rituximab

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Bita Esmaeli, MD / Professor

Number of Participants With Complete Response (CR) or Partial Response (PR)

Overall Study

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

B-cell Lymphoma

Marginal Zone Lymphoma

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.

^111 In Ibritumomab Tiuxetan

Felipe Samaniego, MD

Primary Objective:

* Overall Response Rate (ORR).

Secondary Objectives:

* The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders.
* Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR).
* Time to next anticancer therapy (TTNT).

\^90 Y Ibritumomab tiuxetan and rituximab are both designed to attach to lymphoma cells, causing them to die.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Your blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen, and pelvis. You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test.

The study doctors will first make sure that your disease has not spread too much and is not too severe to require immediate treatment with chemotherapy before you can begin treatment on this study. If you are found to be eligible to take part in this study, you will be given Benadryl (diphenhydramine) by vein, and you will be given Tylenol (acetaminophen) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over 6 to 8 hours on Day 1 of treatment. After treatment with rituximab, you will then be given a radioactive antibody, \^111 In Ibritumomab tiuxetan (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.

You will have imaging performed (with the special camera) on Day 1 and on either Day 2 or Day 3. On Day 8, you will receive a second dose of rituximab. This will then be followed by a dose \^90 Y Ibritumomab tiuxetan of given by vein over 10 minutes. This completes the treatment.

If you experience intolerable side effects while on this study, you may be removed from this study. The study doctor will then offer other treatment options to you.

For your follow-up, you will have blood (about 2 tablespoons) drawn once a week for the first 3 months, then every 3 months for 1 year, and then every 4 months for the second year. At these visits, you may also have CT scans, x-rays, and bone marrow biopsies and aspirates performed, if needed.

This is an investigational study. \^90 Y Ibritumomab tiuxetan and rituximab have been approved by the FDA for the treatment of indolent B-cell lymphoma. Up to 35 patients will take part in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.

Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

Multicenter Phase II Study for Zevalin® in Patients With Relapsed/Refractory Indolent Lymphomas: Extranodal Marginal Lymphoma of MALT Type, Nodal Marginal Zone B-Cell Lymphoma, and Splenic Marginal B-Cell Lymphoma

Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.

Ibritumomab Tiuxetan + Rituximab

Felipe Samaniego, MD / Associate Professor

One participant did not receive treatment and was excluded from analysis.

Objective Response Rate

CHOP

Ibritumomab Tiuxetan

John D. Hainsworth, MD

In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.

Upon determination of eligibility, patients will be receive:

* Rituxan + CHOP or CVP + Ibritumomab Tiuxetan

Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)

Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma

Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma

SCRI Development Innovations, LLC

Behaviors and Mental Disorders

Lymphoma, Large B-Cell, Diffuse

Aggression

Diffuse Large B-Cell Lymphoma

ibritumomab tiuxetan

BEAM chemotherapy and autologous stem-cell transplantation

Avichai Shimoni, MD

Amrita Krishnan, MD

The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.

Zevalin-beam for Aggressive Lymphoma

SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed Diffuse Large B-cell Lymphoma

complete response (CR) and partial response (PR) proportion at day 100,

incidence of infection, grade III-IV toxicities, treatment-related mortality

incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).

City of Hope Medical Center

Amsterdam UMC, location VUmc

University of Göttingen

Sheba Medical Center

Dr. Avichai Shimoni

ibritumomab tiuxetan (zevalin) BEAM

ibritumomab tiuxetan: 0.4 mCi/kg

BEAM chemotherapy and autologous stem-cell transplantation

Z-BEAM

standard BEAM chemotherapy

BEAM chemotherapy and autologous stem-cell transplantation

Standard BEAM

Total

Age, Categorical

Age, Continuous

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Netherlands

Israel

Germany

Dr Avichai Shimoni

Overall Survival

Progression-free Survival

Clinical Response

Hematopoietic Recovery

Grade III Toxicity

Secondary Malignancies

Bortezomib

Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.

rituximab

bortezomib

Jane Winter, MD

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.

This is a phase I, dose-escalation study of bortezomib followed by a phase II study.

Phase I:

- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22, rituximab IV on days 8 and 15, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 15.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

- Consolidation therapy: Beginning 6-7 weeks after completing induction therapy, patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Phase II: Patients receive induction therapy and consolidation therapy as in phase I, with bortezomib administered at the MTD determined in phase I.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

A total of 24 patients will be accrued for this study.

Phase I/II Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma

A Phase I/II Trial of Combined Weekly Bortezomib (VELCADE®) and Y-90-Ibritumomab Tiuxetan (Zevalin) in Patients With Relapsed or Refractory Follicular Lymphoma and Transformed Non-Hodgkin's Lymphoma

To determine the MTD using a 3+3 dose escalating design. There will be 3 dose cohorts:1.0mg/m2,1.3mg/m2 and1.6 mg/m2. 3 patients will be enrolled at dose of 1.0mg/m2 bortezomib. If no dose limiting toxicities (DLTs) are seen in the first 3 patients then dose will be escalated to next level and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced.

DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0.

DLTs=grade 3 nausea, vomiting, diarrhea or ileus more than 96h; grade 4 nausea, vomiting, diarrhea or ileus,neuropathic pain, peripheral sensory neuropathy, neutropenia, thrombocytopenia.

To further explore the toxicity bortezomib combined with Y-90-ibritumomab tiuxetan by collecting data on adverse events (AE) reported by patient or collected lab results that are grade 3 or grade 4 that were determined to be at least possible related to any of the studies drugs.

Toxicity will be collected on treatment days according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Robert H. Lurie Cancer Center

Northwestern University

Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.

During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.

Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.

Cohort 1: 1.0mg/m2 Bortezomib

Cohort 2: 1.3mg/m2 Bortezomib

Cohort 3: 1.6mg/m2 Bortezomib

Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.

During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose (MTD) or at the determined MTD in the expansion phase.

Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.

Expansion Phase: 1.3mg/m2 Bortezomib

Bortezomib, Ibritumomab Tiuxetan, Rituximab

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study closed permanently due to slow accrual with only 17 patients treated on study. This was before the expected accrual goal of 24 patients

Patients enrolled in dose escalation cohorts 1, 2 and 3 analyzed for this outcome measure.

Maximum Tolerated Dose (MTD) and Tolerability of Bortezomib Combined With Y-90-Ibritumomab Tiuxetan Determined by Number of Dose Limiting Toxicities in a Cohort.

Leukopenia

Lymphopenia

Neutropenia

Thrombocytopenia

Cardiac

Cohort 1+ Cohort 2+ Cohort 3

Toxicity data for 9 patients enrolled in the dose escalating cohorts 1, 2 and 3 was collected and analyzed only. Data for the 3 cohorts are presented combined as the objective is to report grade 3 and 4 toxicities with this combination of drugs (dose of bortezomib is irrelevant)

Number of Patients With Adverse Events Related to Treatment of Bortezomib Combined With Y-90-ibritumomab Tiuxetan

The overall response rate at the completion of treatment was defined as complete response plus partial response.

Complete response (CR)=A post-treatment residual mass of any size is permitted as long as it is PET-negative and normalization of those biochemical abnormalities.

Partial response (PR)=50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in the size of the other nodes, liver or spleen, and no new sites of disease.

Stable disease=Failing to attain the criteria for PR or CR, but not fulfilling those for progressive disease.

Progressive disease(PD)=At least a 50% increase from nadir in the SPD of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.

Data for first 9 patients enrolled in phase I dose escalation portion of the study were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant)

Overall Response Rate

Median progression free survival (PFS) will be assessed by CT scans after induction therapy, consolidation therapy, every 3 months for the first year following treatment and every 6 months for the second year.

Progressive disease is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size or at least a 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.

The first 9 patients data that were enrolled in the phase I dose escalation portion were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the PFS of patients with this drug combination (dose was irrelevant)

Median Progression Free Survival

Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.

During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose (MTD), or as the determined MTD in the expansion phase.

Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.

Cohort 1: Dose Level 1.0mg/m2

Cohort 2: Dose Level 1.3mg/m2

Cohort 3: Dose Level 1.6mg/m2

Expansion Phase at Dose 1.3mg/m2

Follow up Until Relapse or Progression

Ibritumomab Tiuxetan (Zevalin) + 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

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

Izidore S. Lossos, MD

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.

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.

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.

Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.

The time from the date of initiation of study treatment until date of death from any cause for all participants.

Percentage of participants still alive five years after the date of protocol therapy initiation.

Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.

University of Miami

Professor

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

Data reported for only 16 of 18 participants due to 2 participants withdrawing consent.

Stage I/II

Stage III/IV

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.

Disease Stage

0, 1 sites

2 or more sites

Number of participants grouped by the number of sites outside of the lymph nodes where lymphoma is present at baseline.

Extranodal disease sites

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.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of participants grouped by the presence of lymphoma cells in the bone marrow at baseline.

Bone Marrow involvement

Normal

Elevated

Number of participants grouped by serum levels of LDH at baseline.

Lactate dehydrogenase (LDH) Levels

5 and less cm

Number of patients grouped by the size of large tumors or lymph nodes in centimeters (cm) present at baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)	NCT00662948	Lymphoma	Rituximab Ibritumomab tiu...	18 Years - 75 Years	PETHEMA Foundation
Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma	NCT00387023	Non-Hodgkin's L... Lymphoma	Rituximab Zevalin	18 Years -	M.D. Anderson Cancer Center
Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas	NCT00493454	Lymphoma	Zevalin Rituximab ^111 In Ibritum...	18 Years -	M.D. Anderson Cancer Center
Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma	NCT00193440	Non-Hodgkins Ly...	Rituximab CHOP CVP Ibritumomab Tiu...	18 Years -	SCRI Development Innovations, LLC
Zevalin-beam for Aggressive Lymphoma	NCT00491491	Non-Hodgkin's L...	ibritumomab tiu... BEAM chemothera...	18 Years - 70 Years	Sheba Medical Center
Phase I/II Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma	NCT00372905	Lymphoma	rituximab bortezomib Ibritumomab tiu...	18 Years -	Northwestern University
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma	NCT00453102	Marginal Zone L...	Rituximab Ibritumomab Tiu...	18 Years - 120 Years	University of Miami
Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma	NCT00290511	Lymphoma	Fludarabine Mitoxantrone Rituximab Zevalin Dexamethasone	60 Years -	M.D. Anderson Cancer Center
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen	NCT00319332	Lymphoma, Small... Lymphoma, Large... Lymphoma, Folli... Lymphoma, Non-H...	Ibritumomab Tiu... Iodine I 131 To...	18 Years -	GlaxoSmithKline
Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma	NCT00193440	Non-Hodgkins Ly...	Rituximab CHOP CVP Ibritumomab Tiu...	18 Years -	SCRI Development Innovations, LLC
Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas	NCT00493454	Lymphoma	Zevalin Rituximab ^111 In Ibritum...	18 Years -	M.D. Anderson Cancer Center
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas	NCT00493467	Lymphoma	Ibritumomab Tiu... Rituximab	18 Years -	M.D. Anderson Cancer Center

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