Clinical Trials Logo

Clinical Trial Summary

The innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. we have proposed a two-stage stratification into risk groups: Initially: - Standard risk: patients with no rearrangement of the KMT2A gene. - Intermediate risk: patients with rearrangement of the KMT2A gene without damage to the central nervous system. - High risk: patients with rearrangement of the KMT2A gene with lesions of the central nervous system. According to the results of induction therapy: - The high-risk group includes patients from the standard risk group with an MRD level of more than 0.1% after the induction course and from the intermediate risk group with MRD-positive (PCR) after HR1 block. - The allocation of children in the first year of life without the rearranged KMT2A gene into a separate group seems to be logical, since the prognosis in this group is better than in children with the rearranged KMT2A gene. In this protocol, non-intensive therapy with consolidations and maintenance therapy remains for those who achieve a low MRD level (less than 0.1%) after a course of induction. The rest of the patients move into a high-risk group: they receive blinatumomab and HSCT. - The concept of therapy for patients at intermediate risk is based on the rate at which MRD-negativity is achieved: standard consolidation and maintenance therapy for those who became MRD-negative at the end of induction, "block" chemotherapy for those who were positive at the end of induction, but achieved negativity after HR1 block, blinatumomab with HSCT for those who have preserved the MRD after the HR1 block. - For high-risk patients, a combination of immunotherapy (blinatumomab - a bispecific CD3 / CD19 T-cell activator) and HSCT in the first remission was chosen.


Clinical Trial Description

- Standard risk group: - Induction of remission: 36 days of dexamethasone, 5 weekly injections of vincristine, 2 injections of daunorubicin on days 8 and 22, a single injection of pegelated asparaginase on days 5-7 and 6 weekly intrathecal injections of three drugs (methotrexate, cyamethosar and dexamethason ). - Further therapy in this therapeutic group depends on the status of remission, the level of MRD on the 36th day of therapy. - MRD-negative patients receive consolidation therapy in the amount of 3 consolidations (6-mercaptopurine, methotrexate, peg-asparaginase, daunorubicin) with re-induction courses (dexamethasone, vincristine) and maintenance therapy (6-mercaptopurine, methotrexate). - MRD-positive patients receive a course of blinatumomab and HSCT. - Intermediate risk group: - Induction of remission: 36 days of dexamethasone, 5 weekly injections of vincristine, 2 injections of daunorubicin on days 8 and 22, a single injection of pegelated asparaginase on days 5-7, 6 weekly intrathecal injections of three drugs (methotrexate, cyamethosar, dexamethasone). - Further therapy in this therapeutic group depends on the status of remission on the 36th day of therapy. - Patients who have achieved molecular remission receive consolidation therapy in the amount of 3 consolidations with re-induction courses and maintenance therapy. - Patients who have not achieved molecular remission receive HR1 block. Further therapy depends on the remission status after HR1 block. Patients who have not achieved molecular remission receive a course of blinatumomab and HSCT, patients who have achieved molecular remission, two more blocks HR2 and HR3, protocol II and maintenance therapy. - High risk group: - Induction of remission: 36 days of dexamethasone, 5 weekly injections of vincristine, 2 injections of daunorubicin on days 8 and 22, a single injection of pegelated asparaginase on days 5-7, 6 weekly intrathecal injections of three drugs (methotrexate, cyamethosar, dexamethasone). - Further therapy in this therapeutic group does not depend on the status of remission on the 36th day of therapy. - All patients receive HR1 block, blinatumomab course and HSCT (subject to morphological remission). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05029531
Study type Interventional
Source Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Contact Natalya f Myakova, PD
Phone +79035083576
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 1, 2021
Completion date July 1, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Recruiting NCT04049383 - CAR-20/19-T Cells in Pediatric and Young Adult Patients With Relapsed/Refractory B Cell ALL Phase 1
Recruiting NCT04472286 - Healthy Bones, Healthy Life
Recruiting NCT03035344 - Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL) N/A
Recruiting NCT03705507 - International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia Phase 1/Phase 2
Recruiting NCT04325841 - Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children Phase 2
Recruiting NCT03020030 - Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents Phase 3
Recruiting NCT03157323 - Low GI Diet in Children and Adolescents With ALL N/A
Recruiting NCT04996160 - Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2) Phase 1
Recruiting NCT03643276 - Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 Phase 3
Recruiting NCT04088864 - CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies Phase 1
Enrolling by invitation NCT04770922 - Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
Not yet recruiting NCT04228393 - The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China Phase 2/Phase 3
Recruiting NCT04400071 - Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment N/A
Recruiting NCT05045443 - Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia Phase 2