Neoplasms

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Lymphoma, Large B-Cell, Diffuse

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Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, B-Cell

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Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

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Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Zevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen

Conditioning regimen followed by allogeneic hematopoietic stem cell transplantation.

Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)

Ibritumomab Tiuxetan (Zevalin)

Krimo BOUABDALLAH, MD

Geneviève CHENE, Pr

The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

The benefit of Zevalin® in the setting of autologous stem cell transplantation has been largely reported. The addition of Zevalin® to a fludarabine-based Reduced Intensity Conditioning regimen has been already evaluated in the setting of allo-SCT and the results reported so far seem to be promising without an overwhelming toxicity neither a delayed hematologic recovery. The assumption that the addition of Zevalin® to the conditioning regimen might improve lymphoma control and the demonstration that nucleoside analogs such as fludarabine synergize optimally with RIT led us to conduct this trial using the following preparative regimen: rituximab 250 mg/m² on days -21 and -14, Zevalin® 0,4 mCi/Kg body weight on day -14, fludarabine 30 mg/m² intravenously from days -6 to -2, Busulfan orally (4 mg/Kg body weight) or intravenously (0,8 mg/Kg body weight) on days -5 and -4 and ATG (Thymoglobulin®) 2,5 mg/Kg body weight intravenously on day -1. Cyclosporine A is administered at 2 or 3 mg/Kg body weight from day -1 to day 28 than followed by a dose reduction.

The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen

Patients are followed from the beginning of the RIC regimen until day 365 for primary and secondary objectives of the study than on a regular basis depending on the practice of each centre. The evaluation includes physical examination (performance status, hematologic assessment, acute and chronic GVH disease), biologic tests (blood screening for blood count, renal and hepatic function, B and T-cell recovery, chimerism analysis, response assessment) and complementary examinations (marrow biopsies, tomography scan, positron emission tomography, ...).

Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)

Safety and Efficacy of Ibritumomab Tiuxetan (Zevalin®) in Association With a Fludarabine Based Reduced Conditioning Regimen and Allogenic Stem Cell Support in Chemo-sensitive Relapsed CD20 Positive Aggressive Non-Hodgkin's Lymphoma Patients.

Bayer

University Hospital, Bordeaux

Antirheumatic Agents

Rituximab

Melphalan

Thiotepa

Antineoplastic Agents, Immunological

Immunologic Factors

Conditioning Regimen

1. Rituximab, 250 mg/m2 on days -21 and -14.
2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.

Chemotherapy:

* Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
* Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.

Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:

* Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
* Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
* Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.

Dolores Caballero, MD

To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.

Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

During Zevalin treatment, rituximab 250 mg/m2 will be administered with the same methods mentioned above on days 1 and 8. On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight for patients with a platelet count \> 150,000/L and 0.3 mCi/kg actual body weight for patients with a platelet count of 100,000 - 149,000/L will be injected intravenously over a period of 10 minutes. The maximum allowable dose of 90Y Zevalin is 32 mCi regardless of the patient's body weight. 90Y Zevalin should be administered within 4 hours after radiolabeling of Zevalin with 90Y.

ibritumomab tiuxetan (Zevalin)

This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).

The patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL) are known to have a poor prognosis as like to those with advanced disease. However, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. Defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. We assessed the clinical efficacy and toxicity of 6th R-CHOP chemotherapy and followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky DLBCL.

90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma

Phase II Study of 90Y-ibritumomab Tiuxetan Treatment as a Consolidation After 6th R-CHOP Chemotherapy in Patients With Limited-stage, Bulky Diffuse Large B Cell Lymphoma

Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation.

After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months.

Samsung Medical Center

Asan Medical Center

Chonbuk National University Hospital

Dong-A University Hospital

Pusan National University Hospital

Severance Hospital

Chonnam National University Hospital

Je-Jung Lee

Ibritumomab Tiuxetan (Zevalin) + Rituximab

111In Zevalin (5 mCi of \^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1.

90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8.

250 mg/m\^2 Intravenously Over 4-6 Hours On Days 1 and 8.

Felipe Samaniego, MD

The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.

90 Y Zevalin 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 "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. 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 (stomach area), and pelvis.

A PET scan is also recommended. A PET (Positron Emission Tomography) scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body. The radioactive solution is either inhaled as a mist or injected into a vein. The radioactive solution is usually made from simple sugar that has radioactive particles attached to it. After the solution is injected into a vein or inhaled, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the extent of disease in certain organs in the body.

You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). 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 or urine pregnancy test.

If you are found to be eligible to take part in this study, you will be given diphenhydramine (Benadryl) by vein and you will take acetaminophen (Tylenol) 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 about 4-6 hours on Day 1 of treatment. After treatment with rituximab, you will then be given 111 In Zevalin (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 (on a camera, like an x-ray) on either Day 2 or 3. On Day 8 (7 days after the first dose of rituximab) you will receive a second dose of rituximab. You will also be given Benadryl, Tylenol, and 90Y Zevalin in the same manner as on Day 1.

If you experience intolerable side effects while on this study, you may be removed from this study. Your treatment on the study will end on Day 8.

You will return for follow-up tests for 4 years. Blood (about 2 tablespoons) will be drawn weekly for the first 3 months. Blood (about 2 tablespoons each time) will also be drawn at month 6 and 9 of the first year, and every 6 months in the second, third, and fourth years. You may also have CT scans, PET scans (which are recommended), x-rays, and bone marrow biopsies and aspirates performed, if your doctor thinks they are necessary.

Your participation on this study will end in about 4 years.

This is an investigational study. 90 Y Zevalin and rituximab are FDA approved and commercially available. Their use in this study is investigational. Up to 36 patients will take part in this multicenter study. Up to 36 patients will be enrolled at M. D. Anderson.

Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas

Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas

ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.

PFS measured, in a responder, from the date when a CR, CRu or PR is first noted to the first date at which progressive disease is observed or death. An ongoing PFS interval occurs when there is a responder for whom progressive disease has not been noted. Progression of disease defined as enlargement of liver/spleen, new sites observed, new or increased lymph nodes or lymph node masses, or reappearance of bone marrow.

Biogen

CTI BioPharma

M.D. Anderson Cancer Center

Ibritumomab Tiuxetan (Zevalin): 111In Zevalin (5 mCi of \^111In, 1.6 mg of Ibritumomab Tiuxetan) intravenous (IV) over 10 minutes on Day 1; 90Y Zevalin 0.3 or 0.4 mCi/kg IV over 10 minutes on Day 8. Rituximab: 250 mg/m\^2 IV over 4-6 Hours on Days 1 and 8 prior to the administration of 111In Zevalin and 90Y Zevalin, respectively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)	NCT00607854	Diffuse Large B... Mantle Cell Lym...	Ibritumomab Tiu...	18 Years - 65 Years	University Hospital, Bordeaux
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)	NCT00644371	Non-Hodgkin Lym...	Ibritumomab Tiu...	18 Years - 65 Years	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma	NCT01157988	Lymphoma, Large...	ibritumomab tiu...	18 Years -	Chonnam National University Hospital
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas	NCT00493467	Lymphoma	Ibritumomab Tiu... Rituximab	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ibritumomab tiuxetan (zevalin)