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Lymphoma, Non-Hodgkin clinical trials

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NCT ID: NCT00996996 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) for Previously Untreated, Advanced-stage, Low Grade Non-Hodgkin's Lymphoma

Start date: June 1996
Phase: Phase 2
Study type: Interventional

This is a single-arm, single-institution, phase II study of Iodine-131 Anti-B1 Antibody for patients with previously untreated, advanced-stage (stage III or IV) low-grade non-Hodgkin's B-cell lymphoma. A total of 75-80 patients will be enrolled. Patients will undergo two phases of the study. In the first phase, termed the "dosimetric dose", patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70 minutes (including a 10-minute flush) immediately followed by a 30-minute infusion (including a 10-minute flush) of Anti-B1 Antibody (35 mg) which has been trace-labeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained 5 to 8 times between Days 0 and 7 following the dosimetric dose. Using the dosimetric data from 3 imaging timepoints (the imaging timepoints to be used in decreasing order of preference depending on availability of data are Days 0, 3, and 7; Days 0, 4, and 7; Days 0, 3 and 6; Days 0, 4, and 6; Days 0, 2, and 7; and Days 0, 2, and 6), a patient-specific dose of Iodine- 131 to deliver the desired total body dose of radiotherapy will be calculated. In the second phase, termed the "therapeutic dose", patients will receive a 70-minute infusion (including a 10-minute flush) of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion (including a 10-minute flush) of Anti-B1 Antibody (35 mg) labeled with the patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy. Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose). The primary endpoint of the study is the determination of the response rate with Iodine-131 Anti-B1 Antibody in previously untreated patients with low-grade non-Hodgkin's lymphoma (NHL). The secondary endpoints include duration of response, safety, radiation dosimetry, and the predictive value of detection of the presence or absence minimal residual disease by molecular techniques on response duration.

NCT ID: NCT00996593 Completed - Clinical trials for Non-Hodgkin's Lymphoma

Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab

Start date: July 1998
Phase: Phase 2
Study type: Interventional

This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who were previously treated with rituximab antibody. Patients must have been treated with at least 4 doses of rituximab and have progressed during or following rituximab therapy. Patients will undergo two dosing phases of study. In the first phase, termed the "dosimetric dose", patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70 minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the "therapeutic dose", patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients with no hematologic risk factors. Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose). The endpoints of the study are to determine the response rate, complete response rate, duration of response, and time to progression or death, based on both a Masked Independent Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody therapy in NHL patients who have previously been treated with rituximab.

NCT ID: NCT00994643 Completed - Clinical trials for High Risk Non-Hodgkin's Lymphoma

Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma

Start date: February 5, 2009
Phase: Phase 2
Study type: Interventional

This is a study to see if maintenance therapy with low dose interleukin-2 (IL-2) and rituximab can delay or prevent recurrences in patients with high risk Non-Hodgkin's Lymphoma (NHL). IL-2 is a naturally occurring cytokine in our immune system which may enhance the activity of a known therapeutic agent rituximab, a monoclonal antibody against CD-20, in the setting of NHL.

NCT ID: NCT00994500 Completed - Clinical trials for Unspecified Childhood Solid Tumor, Protocol Specific

Vorinostat and Bortezomib in Treating Young Patients With Refractory or Recurrent Solid Tumors, Including Central Nervous System Tumors and Lymphoma

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib in treating young patients with refractory or recurrent solid tumors, including CNS tumors and lymphoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

NCT ID: NCT00992758 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma (NHL) Patients With Greater Than 25% Bone Marrow Involvement

Start date: May 28, 1999
Phase: Phase 1
Study type: Interventional

This is a phase I, dose escalation, open-label, multicenter study of iodine-131 Anti-B1 Antibody for patients with non-Hodgkin's lymphoma (NHL) who have more than 25% bone marrow involvement with NHL. Prior studies with Iodine-131 Anti B1 Antibody for the treatment of NHL have excluded patients with more than 25% bone marrow involvement with NHL. To be eligible, patients must have been previously treated and failed to achieve an objective response on or relapse during or following their last treatment. Patients will undergo two dosing phases while on study. In the first phase, termed the "dosimetric dose", patients will receive 450 mg unlabeled Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5 mCi of Iodine-131 infused over 20 minutes. Whole body camera scans will be obtained on Day 0, Day 2, 3, or 4, and Day 6 or 7 following the dosimetric dose. Using dosimetric data from three imaging time points, a patient-specific dose of Iodine-131 Anti-B1 Antibody to deliver the desired total body dose of radiotherapy will be calculated. In the second phase, termed the "therapeutic dose", 450 mg Anti-B1 Antibody will be infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to deliver the desired total body radiation, infused over 20 minutes. The dose escalation will be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated dose (MTD) is reached. Patients will be treated with either saturated potassium iodide, Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the infusion of the dosimetric dose and continuing for 14 days following the last infusion of the therapeutic dose. The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1 Antibody in patients with previously treated NHL having more than 25% bone marrow involvement with lymphoma. Secondary endpoints include assessment of response rate, duration of response, relapse-free survival, time to treatment failure, safety, and survival.

NCT ID: NCT00992446 Completed - Clinical trials for Mantle Cell Lymphoma

Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

Start date: September 2, 2010
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well bortezomib and vorinostat work in treating patients with non-Hodgkin lymphoma (NHL) after patients' own stem cell (autologous) transplant. Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells and make them more likely to die by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus kill lymphoma cells that remain after transplant.

NCT ID: NCT00991211 Completed - Clinical trials for Follicular Lymphomas

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

NCT ID: NCT00989664 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-refractory Low-grade or Transformed Low-grade B-cell Non-Hodgkin's Lymphoma

Start date: November 1996
Phase: Phase 2
Study type: Interventional

The results from Phase 1/2 (RIT-I-000) and Phase 2 (RIT-II-001) studies of Tositumomab and Iodine I 131 Tositumomab (TST/I-131 TST) demonstrated that TST/ I-131 TST produced a high response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed low-grade Non-Hodgkin's Lymphoma (NHL). On the basis of these results this study was designed to compare the efficacy of TST/ I-131 TST to the last qualifying chemotherapy regimen in patients with chemotherapy-refractory, low-grade or transformed low-grade NHL.

NCT ID: NCT00989586 Completed - Lymphoma Clinical Trials

Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory B-cell NHL. The phase I study will be followed by a pilot phase II study.

NCT ID: NCT00985699 Completed - Lymphoma Clinical Trials

S8516-S8736-S9125-S9240 Research Study of Genes in Tissue Samples From Patients With B-cell Non-Hodgkin Lymphoma

Start date: April 2009
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell non-Hodgkin lymphoma.