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Lymphoma clinical trials

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NCT ID: NCT00463463 Recruiting - Clinical trials for Non-Hodgkin's Lymphoma

Zevalin and BEAM High-dose Chemotherapy Compared With BEAM Alone as Conditioning Regimen in Patients With Chemosensitive Relapse of Non-Hodgkin's Lymphoma

Zevalin
Start date: April 2007
Phase: Phase 3
Study type: Interventional

High-dose chemotherapy and autologous stem-cell transplantation have an established role in the treatment of aggressive Non-Hodgkin's lymphoma (NHL) when refractory to first line chemotherapy or after relapse. The PARMA study randomized 109 patients, with chemo-sensitive relapse and no marrow involvement to receive, following the initial salvage regimen, high-dose chemotherapy versus continuous standard dose chemotherapy. 5-year progression-free survival was 46% in the transplant group compared with 12% in the chemotherapy group. Results are significantly inferior in patients with multiply relapsed or chemo-refractory disease with only 0-20% of patients achieving long-term disease control with autologous transplantation. Thus a large proportion of patients with refractory and relapsing disease are not cured with currently available transplantation methods and newer approaches are required. Rituximab is the first monoclonal antibody approved for clinical use. It is an anti CD20 antibody with high response rate in the treatment of follicular lymphoma and increases response rate in aggressive lymphoma when combined with chemotherapy. It is well tolerated with minimal side effects. However tumors may escape rituximab sensitivity by loss of antigen, poor access of antibody to bulky or poorly vascularized tumors, or failure of host effectors to eliminate antibody binding tumor cells. Lymphoma cells are inherently and exquisitely sensitive to radiation. Radioimmunotherapy uses monoclonal antibodies conjugated with a radioactive isotope to target radiation directly to tumor cells. Ibritumomab is the parent murine anti CD20 antibody witch targets the same epitope as rituximab. Tiuxetan is a chelator covalently linked to the antibody which chelates the isotope 90Yttrium to form the active radioconjugate Zevalin. 90Yttrium is a pure high-energy beta emitter with a relatively short half time (64 hours) and a path length of 5 mm. These properties make it an ideal isotope for radioimmmunotherapy. The high energy and long beta path are advantageous in treating bulky, poorly vascularized tumors, and tumors with heterogeneous antigen expression as neighboring tumor cells can be hit by cross fire from tumors binding the radioconjugate. Pure beta emission limits radiation to the patient body and is safe for the surrounding allowing simple outpatient care, no need for patient isolation or shielding. Biodistribution is predictable, eliminating the need for dosimetry. Initial studies showed that Zevalin has a favorable toxicity profile and is more effective than rituximab in patients with follicular and transformed non-Hodgkin's lymphoma, and studies are currently performed in aggressive lymphoma. There are initial phase I-II studies combining radioimmunotherapy with high-dose chemotherapy and autologous stem-cell transplantation with promising results. We conducted a phase II study of fixed-dose Zevalin at 0.4 mCi/kg with BEAM high-dose chemotherapy in patients with chemo-refractory disease. So far, 23 patients were included. With a median follow-up of 17 months the estimated progression-free survival was 52% compared with 0-20% expected in patients with multiply relapsed and chemo-refractory disease. Based on these data and data from other groups we expect that the addition of Zevalin to standard high-dose chemotherapy will improve transplantation outcomes in patients with standard-risk chemosensitive disease, as well. This study will randomize patients to Zevalin-BEAM versus BEAM alone to determine the potential of Zevalin radioimmunotherapy to improve outcome of autologous stem-cell transplantation.

NCT ID: NCT00455416 Recruiting - Follicular Lymphoma Clinical Trials

Dietary Intervention in Follicular Lymphoma

KLYMF
Start date: April 2007
Phase: Phase 2
Study type: Interventional

A dietary intervention study in patients with Follicular Lymphoma (FL) Stage III/IV to assess the ability of several dietary factors to induce apoptosis, inhibit cell proliferation and modulate tumor cell infiltrate in vivo.

NCT ID: NCT00455286 Recruiting - Clinical trials for Primary Central Nervous System Lymphoma

a Phase II Study in Primary Central Nervous System Lymphoma

Start date: November 2006
Phase: Phase 2
Study type: Interventional

In this study we will test the hypothesis that concurrent chemoradiation (CCRT) with temozolomide after induction chemotherapy by conventional high-dose methotrexate (HD-MTX) plus dexamethasone may be an effective and well tolerated treatment for immunocompetent patients with PCSNL. Corticosteroid can effectively reduce brain edema and corticosteroid alone has resulted in complete or partial remission in about 40% patients with PCNSL. To enhance local disease control, CCRT with temozolomide will be used in the study. Temozolomide is a well-tolerated oral alkylating agent that is able to permeate the BBB. Concurrent temozolomide with WBRT has shown superior effect to WBRT alone for the treatment of metastatic brain tumors and glioblastoma multiforme. In addition, temozolomide has single-agent activity for PCNSL (21% CR in relapsed or refractory PCNSL in a phase II trial). This is an open-label, non-randomized, multi-center phase II study. The primary end point of is the complete response rate. This study is a two-stage design for testing non-inferiority of the proposed treatment as compared to the approximately 80% response rate reported for conventional treatment. Assuming a non-inferiority margin of 20%, a sample size of 25 subjects, which provides an 80% power for establishment of non-inferiority. At the first stage, 15 subjects are to be enrolled. If equal to or more than 6 patients achieve complete response, the study would accrue additional 10 subjects. The treatment regimen is as follows. Induction chemotherapy: MS regimen (repeated every 14 days, total 4 cycles) - Methotrexate 3.5 g/m2 i.v. infusion 4 hours on day1 - Methylprednisolone 200 mg/m2/day i.v. infusion 30 minutes, on day1-4 Concurrent chemoradiotherapy (CCRT) - Whole brain radiation therapy (WBRT) 2 Gy per fraction daily, 5 days per week Temozolomide 75 mg/m2/day orally daily, only on the days of WBRT

NCT ID: NCT00445497 Recruiting - Lymphoma Clinical Trials

Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia

Start date: July 2007
Phase: Phase 3
Study type: Interventional

RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia. PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.

NCT ID: NCT00441818 Recruiting - Hodgkin's Lymphoma Clinical Trials

Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma

Start date: May 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of TNX-650 for Injection when administered to patients with refractory Hodgkin's lymphoma.

NCT ID: NCT00429065 Recruiting - Clinical trials for Non-Hodgkin Lymphoma

Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.

Start date: January 2007
Phase: Phase 4
Study type: Observational

The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.

NCT ID: NCT00398177 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma and Hodgkin's Disease

Start date: January 1999
Phase:
Study type: Observational

The purpose of this study is to characterize the molecular and cell biology of the tumor cells in lymphoma.

NCT ID: NCT00384553 Recruiting - Clinical trials for Non-Hodgkin's Lymphoma

Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma

Start date: June 2004
Phase: Phase 1/Phase 2
Study type: Interventional

This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.

NCT ID: NCT00363090 Recruiting - Lymphoma Clinical Trials

Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma

Start date: September 2006
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as alemtuzumab, 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

NCT ID: NCT00333008 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.

Start date: May 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.