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Lymphoma, Non-Hodgkin clinical trials

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NCT ID: NCT01900509 Completed - Hodgkin Lymphoma Clinical Trials

Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies

Start date: August 2013
Phase: Phase 1
Study type: Interventional

Participants with relapsed or refractory leukemia or lymphoma will be recruited for this study to find whether or not the addition of a new drug called bendamustine will be safe and possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug Administration (FDA) for the treatment of other cancers in adults that are similar to those being studied in the research trial. PRIMARY OBJECTIVES - To establish the maximum tolerated dose (MTD) of bendamustine in combination with clofarabine and etoposide in pediatric participants with hematologic malignancies. - To characterize the safety profile and dose-limiting toxicities (DLTs) of bendamustine in combination with clofarabine and etoposide. SECONDARY OBJECTIVES - To estimate event-free survival at 4 months. - To estimate minimal residual disease (MRD) levels present at end of each cycle of therapy in participants with leukemia. - To characterize the pharmacokinetic profile of bendamustine in the proposed regimen.

NCT ID: NCT01897012 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas

Start date: July 17, 2013
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of alisertib and romidepsin in treating patients with B-cell or T-cell lymphomas that have returned after a period of improvement (relapsed) or have not responded to treatment (refractory). Alisertib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT01889797 Completed - Clinical trials for Indolent Non-Hodgkin's Lymphoma

Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

PrE0401
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response. Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma. GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab. PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab) Approximately twenty-five patients randomized to GA101 may participate in the sub-study. Electrocardiograms and blood samples will be obtained.

NCT ID: NCT01882803 Completed - Clinical trials for Indolent Non-Hodgkin Lymphoma

A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

DYNAMO
Start date: June 17, 2013
Phase: Phase 2
Study type: Interventional

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

NCT ID: NCT01878890 Completed - Solid Tumors Clinical Trials

Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.

ESCALE
Start date: September 5, 2011
Phase: Phase 1
Study type: Interventional

Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz. Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in order to determine the maximum tolerated dose to improve therapeutic effect. This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic cancer) and non-Hodgkin lymphoma (NHL). Main objective is to determine the safety profile, and particularly the maximum tolerated dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer) or NHL in therapeutic failure. Secondary objectives are: - Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks; - Evaluate objective response at 12 weeks; - Evaluate progression free survival at 6 months; - Assess biological progression-free survival at 6 months (prostate tumours only). Primary Endpoint Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of Efavirenz and will be defined as follows: - Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia, nausea and vomiting, regardless of grade), - Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days, - Score ≥ 19 HAD during treatment. Secondary Criteria - Solid tumors: response and progression defined by RECIST v1.1 [Eisenhauer EA et al. EJC 2009). - Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria [Cheson BD et al. JCO 1999] - Biological progression (particular case of prostate tumors): defined according to Scher [Scher HI et al. JCO 2008] Statistical Considerations This is a Phase I dose escalation strategy using the method CRML, described by O'Quigley and Shen [O'Quigley et al. Biometrics 1996] and commonly used in Phase I trials in oncology. - Maximum number of eligible and evaluable subjects is 30. - Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000 mg. - The risk of dose limiting toxicities maximum allowed is 25%.

NCT ID: NCT01871675 Completed - Lymphoma Clinical Trials

Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.

NCT ID: NCT01870479 Completed - Clinical trials for Non Hodgkin´s Lymphomas

Music & Cancer - Live Music During Chemotherapy

Start date: May 2013
Phase: N/A
Study type: Interventional

Main purpose: To determine if live music moderates the level of chemotherapy related anxiety, in patients with haematological cancer The investigators hypothesize that live music: 1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment 2. May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients. 3. Is more effective in patients with good musical abilities. 4. Is more effective than taped music. Method: Intervention groups: 1. Listening to patient-preferred live music during chemotherapy 2. Listening to patient-preferred taped music during chemotherapy 3. Standard care Endpoints: Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines. Background: In order to establish the intervention procedures, the investigators have carried out a pilot study at the hematology department at Hospital of Southwest Denmark, including students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results indicates that live music has an uplifting, pain relieving, and then releasing effect and that music has a positive impact on hospitalisation. According to the evaluation forms filled out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a counterweight to disease fixation and alienation Chemotherapy involves major physical and psychological problems. Not much has been provided in the clinical setting which relieves the symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the need for developing new potential areas of intervention that takes into account, that not only do cancer patients face challenges in everyday life ranging from physiological changes over social to psychological problems, but also during treatment procedures, which may cause a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This project investigates to what degree live music may relieve some of these symptoms during treatment for haematological cancer. The project is created in order to both measure psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These physiological changes are measured in order to shed light on the mechanism behind the potential effects of live music on discomfort in connection with chemotherapy treatment. Perspectives: The vision of the project focus on strengthening the cancer patients' ability to cope with physiological and psychological issues during chemotherapy sessions and to make the patients conscious of music as an option in these coping efforts. Hopefully, the results will provide a scientific basis for an evaluation of the perspectives and the potentials of live music treatment during chemotherapy infusion among cancer patients.

NCT ID: NCT01868035 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP

Start date: May 2000
Phase: Phase 2
Study type: Interventional

This is a multicenter study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH) level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.

NCT ID: NCT01866839 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Preventing Stem Cell Transplant Complications With a Blood Separator Machine

Start date: May 29, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to test a blood separator machine that may help remove more of the donor's white blood cells before transplant. They will study donors and recipients during stem cell transplant to see how well this process can prevent GVHD and other complications. Objectives: - To see if a new blood separator machine can improve outcomes of stem cell transplants. Eligibility: - Individuals between 10 and 75 years of age who are having a stem cell transplant for leukemia or other blood-related cancers. - Donors for the stem cell transplant. Design: - Recipients and donors will be screened with a physical exam and medical history. - Donors will have two blood collection procedures. The first will collect only white blood cells, and return the rest of the blood. After the first collection, participants will have filgrastim injections to help their stem cells enter their blood. Then, they will have a second blood collection for the stem cells. - Recipients will have radiation and chemotherapy to prepare for the stem cell transplant. They will then have the stem cell transplant with the donor cells that have been treated with the blood separator machine. - Recipients will be monitored closely after the procedure. They may receive some of their donor's white blood cells if needed to fight serious infections. - Recipients will have the regular standard of care after their transplant. Blood samples will be taken and any side effects will be monitored and treated.

NCT ID: NCT01865617 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia

Start date: May 22, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of laboratory treated T cells to see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin lymphoma, or acute lymphoblastic leukemia that have come back or have not responded to treatment. T cells that are treated in the laboratory before being given back to the patient may make the body build an immune response to kill cancer cells.