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The clinical trial of AALL0331 is mainly to determine whether pegaspargase intensive therapy can further improve standard risk (SR) subgroup B-cell acute lymphoblastic leukemia with good prognostic characteristics compared with standard pediatric oncology group (COG) low-intensity therapy (B-ALL) The rate of continuous complete remission (CCR) in children.
Professor Leonard A.
Mattano Jr and others recently reported relevant results from the clinical trial of AALL0331.
Research background and purpose At present, the 5-year overall survival (OS) rate of children with B-ALL exceeds 90%.
Choosing the appropriate therapy according to the risk stratification has brought stable survival improvement for children with B-ALL, while also minimizing the toxicity associated with the treatment.
COG was based on a retrospective analysis of early clinical trial data in 2004, integrating the patient’s clinical and biological characteristics, early treatment response, and minimal residual disease (MRD) status.
About 27% of children with B-ALL belonged to SR.
The 4-year event-free survival rate (EFS) of these patients is 91%-92%, and the 4-year OS rate is 95%.
Previous studies have shown that there are two main prognostic factors associated with the ETV6-RUNX1 fusion mutation and the simultaneous presence of the hyperdiploid of chromosome 4, 10, and 17 asparaginase in children with B-ALL.
Related to increased sensitivity.
The retrospective analysis of COG identified B-ALL children in the SR subgroup with good prognostic characteristics, which were defined as good clinical characteristics, early treatment response, and the presence of ETV6-RUNX1 or the presence of chromosomes 4, 10, and 17 For children with trisomy, the probability of recurrence in this group is 10%.
In order to explore the optimal treatment plan for this kind of children with good prognosis and reduce long-term side effects, COG carried out AALL0331 clinical trials.
Research methods The study recruited 5377 SR B-ALL children (ages 1-9 years old, white blood cell [WBC] count <50,000/μL) between 2005 and 2010.
After all patients received the common three-drug combination induction, 1857 eligible children participated in the random allocation of low-risk B-ALL.
Low-risk criteria include no extramedullary disease, bone marrow (BM) blast cell ratio of less than 5% on the 15th day of the first induction therapy, BM MRD <0.
1% at the end of the induction therapy, and good cytogenetic changes (existence of ETV6- RUNX1 fusion gene or the presence of trisomy 4, 10, and 17 at the same time).
Eligible children with low-risk B-ALL were randomly assigned to receive standard COG low-intensity therapy (including two pegaspartase, once during the induction and delayed intensification period), or during consolidation and short-term maintenance treatments every 3 weeks.
Do not use the other four Pegasparase.
The results of the study included 1139 patients (61.
3%) with ETV6-RUNX1 fusion gene mutations involved in random allocation in the study, 712 patients with trisomy (38.
3%), and patients with both 6 cases (accounting for 0.
3%).
The results of the study showed that the 6-year CCR and OS rates of low-risk children were 94.
7%±0.
6% and 98.
7%±0.
3%, respectively.
Among them, the CCR between the two groups of patients receiving pegaspargase intensive therapy (LRA) and standard COG low-intensity therapy (LRS) was similar (95.
3% ± 0.
8% vs 94.
0% ± 0.
8%; P = 0.
13), and the OS rate was not significant Difference (98.
1%±0.
5% vs 99.
2%±0.
3%; P = 0.
99).
In addition, among patients receiving the same treatment plan and similar early response, children with low risk (the presence of the ETV6-RUNX1 fusion gene or the presence of trisomy 4, 10, and 17) have a better prognosis (CCR HR is 1.
95, P=0.
0004; OS HR is 5.
42, P<0.
0001). The incidence of symptomatic pancreatitis in children receiving LRA treatment was higher (3.
7% vs 0.
8%; P <0.
0001), and the severity was mainly moderate (1 case was grade 2, 33 cases were grade 3, and 7 cases were grade 4 ).
Six children who received LRA had cerebral ischemia, and three children who received LRS had cerebral ischemia.
Children who received LRA compared with LRS seemed to have a higher rate of femoral head necrosis (3% vs 1.
8%, P=0.
099), but after the dexamethasone treatment factor was revised, the rate of femoral head necrosis in children who received LRA decreased to 1.
3 %.
Rare adverse events (central nervous system bleeding) occurred in 4 and 3 children treated with LRA and LRS, respectively.
The incidence of pegaspase allergy in children with LRA was higher than that in the LRS group (P=0.
0001).
Similarly, children in the LRA group also had a higher proportion of neutropenia, febrile neutropenia, and The occurrence of infection.
Research conclusions The research shows that for low-risk children with B-ALL with early clinical response and good cytogenetic changes, only standard COG low-intensity therapy can be cured.
It is hoped that while ensuring the excellent curative effect and clinical prognosis of this special type of B-ALL in children, it is expected to reduce the frequency of use of pegaspargase to reduce treatment-related side effects.
References: Leonard A Mattano Jr, Meenakshi Devidas, Kelly W Maloney, et al.
Favorable Trisomies and ETV6-RUNX1 Predict Cure in Low-Risk B-Cell Acute Lymphoblastic Leukemia: Results From Children's Oncology Group Trial AALL0331.
J Clin Oncol.
2021 Mar 19; JCO2002370.
Stamp "read the original text", we make progress together
Professor Leonard A.
Mattano Jr and others recently reported relevant results from the clinical trial of AALL0331.
Research background and purpose At present, the 5-year overall survival (OS) rate of children with B-ALL exceeds 90%.
Choosing the appropriate therapy according to the risk stratification has brought stable survival improvement for children with B-ALL, while also minimizing the toxicity associated with the treatment.
COG was based on a retrospective analysis of early clinical trial data in 2004, integrating the patient’s clinical and biological characteristics, early treatment response, and minimal residual disease (MRD) status.
About 27% of children with B-ALL belonged to SR.
The 4-year event-free survival rate (EFS) of these patients is 91%-92%, and the 4-year OS rate is 95%.
Previous studies have shown that there are two main prognostic factors associated with the ETV6-RUNX1 fusion mutation and the simultaneous presence of the hyperdiploid of chromosome 4, 10, and 17 asparaginase in children with B-ALL.
Related to increased sensitivity.
The retrospective analysis of COG identified B-ALL children in the SR subgroup with good prognostic characteristics, which were defined as good clinical characteristics, early treatment response, and the presence of ETV6-RUNX1 or the presence of chromosomes 4, 10, and 17 For children with trisomy, the probability of recurrence in this group is 10%.
In order to explore the optimal treatment plan for this kind of children with good prognosis and reduce long-term side effects, COG carried out AALL0331 clinical trials.
Research methods The study recruited 5377 SR B-ALL children (ages 1-9 years old, white blood cell [WBC] count <50,000/μL) between 2005 and 2010.
After all patients received the common three-drug combination induction, 1857 eligible children participated in the random allocation of low-risk B-ALL.
Low-risk criteria include no extramedullary disease, bone marrow (BM) blast cell ratio of less than 5% on the 15th day of the first induction therapy, BM MRD <0.
1% at the end of the induction therapy, and good cytogenetic changes (existence of ETV6- RUNX1 fusion gene or the presence of trisomy 4, 10, and 17 at the same time).
Eligible children with low-risk B-ALL were randomly assigned to receive standard COG low-intensity therapy (including two pegaspartase, once during the induction and delayed intensification period), or during consolidation and short-term maintenance treatments every 3 weeks.
Do not use the other four Pegasparase.
The results of the study included 1139 patients (61.
3%) with ETV6-RUNX1 fusion gene mutations involved in random allocation in the study, 712 patients with trisomy (38.
3%), and patients with both 6 cases (accounting for 0.
3%).
The results of the study showed that the 6-year CCR and OS rates of low-risk children were 94.
7%±0.
6% and 98.
7%±0.
3%, respectively.
Among them, the CCR between the two groups of patients receiving pegaspargase intensive therapy (LRA) and standard COG low-intensity therapy (LRS) was similar (95.
3% ± 0.
8% vs 94.
0% ± 0.
8%; P = 0.
13), and the OS rate was not significant Difference (98.
1%±0.
5% vs 99.
2%±0.
3%; P = 0.
99).
In addition, among patients receiving the same treatment plan and similar early response, children with low risk (the presence of the ETV6-RUNX1 fusion gene or the presence of trisomy 4, 10, and 17) have a better prognosis (CCR HR is 1.
95, P=0.
0004; OS HR is 5.
42, P<0.
0001). The incidence of symptomatic pancreatitis in children receiving LRA treatment was higher (3.
7% vs 0.
8%; P <0.
0001), and the severity was mainly moderate (1 case was grade 2, 33 cases were grade 3, and 7 cases were grade 4 ).
Six children who received LRA had cerebral ischemia, and three children who received LRS had cerebral ischemia.
Children who received LRA compared with LRS seemed to have a higher rate of femoral head necrosis (3% vs 1.
8%, P=0.
099), but after the dexamethasone treatment factor was revised, the rate of femoral head necrosis in children who received LRA decreased to 1.
3 %.
Rare adverse events (central nervous system bleeding) occurred in 4 and 3 children treated with LRA and LRS, respectively.
The incidence of pegaspase allergy in children with LRA was higher than that in the LRS group (P=0.
0001).
Similarly, children in the LRA group also had a higher proportion of neutropenia, febrile neutropenia, and The occurrence of infection.
Research conclusions The research shows that for low-risk children with B-ALL with early clinical response and good cytogenetic changes, only standard COG low-intensity therapy can be cured.
It is hoped that while ensuring the excellent curative effect and clinical prognosis of this special type of B-ALL in children, it is expected to reduce the frequency of use of pegaspargase to reduce treatment-related side effects.
References: Leonard A Mattano Jr, Meenakshi Devidas, Kelly W Maloney, et al.
Favorable Trisomies and ETV6-RUNX1 Predict Cure in Low-Risk B-Cell Acute Lymphoblastic Leukemia: Results From Children's Oncology Group Trial AALL0331.
J Clin Oncol.
2021 Mar 19; JCO2002370.
Stamp "read the original text", we make progress together
