| Статус: | Recruiting |
| Фаза: | Phase 1/Phase 2 |
| Начало: | 1 сентября 2019 г. |
| Окончание: | 1 декабря 2025 г. |
| Описание: | Therapy of severe intestinal graft-versus-host disease (GVHD) despite the introduction of novel target agents is associated with worse outcome compared to the other forms. Response to steroids is observed only in about 10% of patients. The most promising approaches are JAK inhibition and fecal microbiota transplantation. In this pilot study we evaluate this combination treatment in the first line. |
| смотреть на ClinicalTrials.gov |
| Статус: | Terminated |
| Фаза: | Phase 1 |
| Начало: | 1 июня 2019 г. |
| Окончание: | 29 ноября 2023 г. |
| Описание: | The hypothesis of the study is that according to modern data, the pathogenesis of multiple sclerosis is inextricably linked to the patient's microbiota. Therefore, transplantation of a normal fecal microbiota (FMT) can improve the outcome of autologous hematopoietic stem cell transplantation (autoHSCT) by increasing the disease-free period and disease progression suspension for at least 5 years after transplantation, which meets the NEDA (No Evidence of Disease Activity) criteria, satisfying the current trends of clinical neurology. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1/Phase 2 |
| Начало: | 1 августа 2017 г. |
| Окончание: | 20 декабря 2019 г. |
| Описание: | A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1/Phase 2 |
| Начало: | 27 мая 2017 г. |
| Окончание: | 27 марта 2020 г. |
| Описание: | A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1/Phase 2 |
| Начало: | 27 марта 2017 г. |
| Окончание: | 27 января 2020 г. |
| Описание: | Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need for the introduction of novel treatment regimens. This phase I/II trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 2 |
| Начало: | 1 августа 2016 г. |
| Окончание: | 1 апреля 2019 г. |
| Описание: | Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic stem cell transplantation, while steroid-refractory chronic GVHD significantly increases morbidity, aggravates quality of life and may also impact survival. Currently there is no standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK) inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate and survival of patients with either acute or chronic srGVHD. This study prospectively evaluates the efficacy of ruxolitinib in srGVHD patients. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1/Phase 2 |
| Начало: | 1 июня 2016 г. |
| Окончание: | 1 ноября 2020 г. |
| Описание: | Several groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical, unrelated and related allogeneic stem cell transplantation (SCT). Nonetheless for majority of the grafts, except for 10/10 HLA-matched bone marrow, with this type of prophylaxis require concomitant administration of calcineurin inhibitors±MMF, which delays immune reconstitution and development of graft-versus-leukemia (GVL) effect. So, despite reduction of transplant-related mortality, use of PTCy doesn't lead to the reduction of relapse incidence. This is particularly important for relapsed or refractory acute leukemia patients, where, despite all efforts to intensify conditioning regimens, relapses after SCT occur in more than 50% of patients, and long-term survival rarely exceeds 10-20%. In preclinical model of haploidentical SCT the substitution of post-transplantation cyclophosphamide with bendamustine, led to comparable GVHD control, but significantly augmented GVL effect. To test this hypothesis and improve the outcome of allogeneic SCT in refractory acute leukemia patients we initiated a pilot trial with high-dose post-transplantation bendamustine for GVHD prophylaxis. The selection of doses is based on the previous dose-escalation studies. Additional immunosuppression could be added for mismatched grafts. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1/Phase 2 |
| Начало: | 1 января 2016 г. |
| Окончание: | 1 апреля 2019 г. |
| Описание: | A number of groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand, its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft failure and disease progression in myelofibrosis patients. |
| смотреть на ClinicalTrials.gov |
| Статус: | Terminated |
| Фаза: | Phase 2 |
| Начало: | 1 июля 2015 г. |
| Окончание: | 3 апреля 2019 г. |
| Описание: | Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide (PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow transplantation. There is limitted, but growing data on safety and efficacy of this prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest. On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On the other hand, there is a concern, that PTCy can increase the incidence of graft failures in this group of patients. Currently published data indicate that low-dose Thymoglobulin-based prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the paramter that takes into account the most important factors effecting survival. The conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil and tacrolimus) will be identical in the two arms of the study. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 2 |
| Начало: | 1 октября 2014 г. |
| Окончание: | 1 ноября 2017 г. |
| Описание: | This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in patients with different risk of GVHD. The risk-adapted strategy involves using single-agent cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem cells and mismatched bone marrow. |
| смотреть на ClinicalTrials.gov |