Active clinical trials for "Hodgkin Disease"

The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.

Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation failure represents a typical unmet medical need prompting active development and validation of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide and bendamustine, framing different targets on both tumor and microenvironmental cells of HL. These agents, while showing a low risk of overlapping extrahematologic toxicities, may hit the proliferation machinery of H-RS cells and/or their progenitors, synergistically inhibit tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating in the microenvironment to support tumor cell survival. A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a 28-day cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and protracted doses of alkylators induce a decrease in microvascular density of tumor tissues and inhibit mobilization and viability of circulating endothelial progenitors. The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method chooses doses based-on both response and toxicity, and accounts for the trade-off between these two outcomes.

Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin has been gradually replaced by epirubicin. Polyethylene glycol liposome doxorubicin (PLD) can go into tumor tissues through tumor angiogenesis and produces targeted killing effect to tumor tissues. PLD has potential advantages in the treatment of malignant tumors,including lymphoma.

The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying the side effects of fludarabine phosphate, melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with relapsed Hodgkin lymphoma.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.

Despite a high recovery rate with chemotherapy and radiation therapy treatment, 15 to 30% of patients suffering from Hodgkin lymphoma are refractory or relapsed. Standard rescue treatment for these patients is chemotherapy followed by a hematopoietic stem cell auto-SCT. Despite a very good rate of complete sustainable response in 50% of the patients, another 50% of the patients relapse after increased therapy and require additional treatment. Consequently, one option for these patients is to offer a novel rescue therapy, enabling them to have partial or complete response, and offer them a hematopoietic stem cell allo-SCT. In the only prospective phase 2 study published by Sureda et al. assessing this therapeutic approach, the rate of mortality not linked to relapse was 8% at 100 days and 15% at 1 year. The progression-free survival rate was 48% at 1 year and 24% at 4 years. Relapse occurred between 3 and 35 months with a median of 6 months in 51% of the patients out of a total of 78 patients. Cumulative incidence of relapse was 37% at 1 year and 59% at 5 years. Brentuximab Vedotin (Bv) is an anti-CD30 antibody-drug conjugate. This drug has shown its efficacy with very acceptable toxicity in patients suffering from advanced-stage Hodgkin lymphoma. Bv was consolidatively evaluated after an auto-SCT. 329 patients, at high risk of relapse after auto-SCT, received Bv (n=165) in a dose of 1.8 mg/kg every 3 weeks or a placebo (n=164) for 16 cycles. The progression-free survival median (validated by a panel of independent experts) was 42.9 months (95% CI 30,4-42 ; 9) for patients in the Bv group and 24.1 months (11.5 not reached) in the placebo group. The purpose of our study is to reduce relapse rate by carrying out maintenance with Bv after allografting hematopoietic stem cells in a population of patients suffering from Hodgkin lymphoma with high risk of relapse after auto-SCT. Fifty eight patients have been slated for inclusion over a period of 2 years. This is an open-label, prospective, multicenter, phase II trial consisting of post allo-SCT maintenance Bv for Hodgkin lymphoma. Patients will be recruited over 24 months and be followed for 3 years after allo-SCT. A total of 58 patients will be included in the study. The duration of the treatment period is approximately 10.7 months for 12 cycles of Bv. End of study: end of study is defined by the last visit planned by the protocol of the last patient in follow-up, which means 3 years after allo-SCT.

This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.

Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma

This is a single-arm, open-label, multicenter, phase I/II study to evaluate efficacy and safety of AK105 in patients with relapsed or refractory classic Hodgkin lymphoma.