| Статус: | Completed |
| Фаза: | Phase 2 |
| Начало: | 15 июня 2021 г. |
| Окончание: | 23 января 2023 г. |
| Описание: | The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 2 |
| Начало: | 7 мая 2021 г. |
| Окончание: | 20 мая 2022 г. |
| Описание: | The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | N/A |
| Начало: | 1 февраля 2020 г. |
| Окончание: | 1 декабря 2025 г. |
| Описание: | THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy. QUESTIONS AND OBJECTIVES OF THE STUDY: - to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL; - to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL; - to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness; - to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | N/A |
| Начало: | 1 ноября 2015 г. |
| Окончание: | 1 ноября 2025 г. |
| Описание: | QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY 1. Will the new risk group stratification (especially of T-ALL) to improve overall and event-free survival? 2. Will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults? 3. Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy? 4. Whether the methylprednisolone administration as basic glucocorticoids during induction, consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate, improve survival and therapy compliance in adolescents and young adults with B-precursor ALL? 5. Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC≥100,000/µl will improve treatment outcome? 6. Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and improve survival? |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | N/A |
| Начало: | 1 февраля 2008 г. |
| Окончание: | 1 июля 2020 г. |
| Описание: | QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY 1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission, improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence, decrease of severe infections and early mortality rate? 2. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity? 3. Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment outcome? 4. Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st consolidation in intermediate risk patients will result in decrease of central nervous system relapse incidence and improvement of event-free and overall survival? Whether the increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with enhanced toxicity? 5. Is it possible to completely avoid the cranial irradiation in intermediate risk patients? In some subgroup of intermediate risk patients? Is it enough to control neuroleukemia in these patients to introduce additional TIT in the consolidation phase of treatment? How will change the possible late effects in these patients according to the third arm of randomization? 6. Will the new risk group stratification to improve overall and event-free survival? |
| смотреть на ClinicalTrials.gov |