Therapeutic drug monitoring informs asparaginase dose scheduling in the InPOG-ALL-15-01-ICiCLe-ALL-14 trial

Sidhu, Jasmeet; Saha, Debparna; Roy, Prakriti; Banerjee, Meghna; Paul, Pritha; Samaddar, Samik; Basu, Arindam; Saha, Vaskar; Krishan, Shekhar

doi:10.1016/j.phoj.2017.11.132

Cited by 2 publications

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“…As B cell ALL patients made a large subset of our study group, we looked into the activity of L‐asparaginase based on different risk types due to concerns of asparaginase resistance (Supplementary Figure S3). Contrary to a recently published finding from Krishnan et al, we did not find a major difference in the asparaginase activity levels between different risk subtypes though these findings must be considered in the background of suboptimal activity of generics. To conclude, our findings of lower activity in all Indian generic formulations clearly demonstrates a serious clinical concern in the treatment of pediatric leukemia.…”

Section: Discussioncontrasting

confidence: 99%

A comparison of asparaginase activity in generic formulations of E.coli derived L‐ asparaginase: In‐vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia

Sankaran

Sengupta

Purohit

et al. 2020

Brit J Clinical Pharma

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Aims L‐asparaginase is an essential medicine in the treatment of pediatric acute lymphoblastic leukemia (ALL) and the quality of generic formulations is an area of concern. We compared nine generic formulations of L‐asparaginase available in India with the innovator. Methods The quality of formulations was assessed by measuring 72‐hour trough asparaginase activity in children with ALL during induction following administration of 10,000 IU/m2 of L‐asparaginase. In‐vitro analysis of the label claim was assessed by measuring activity of three generic formulations. Liquid chromatography‐mass spectrometry (LC/MS) was used to determine the amount of host contaminant proteins (HCPs) in the formulations. Results Between March 2015 to June 2018, 240 samples from 195 patients were analyzed. The number of samples analyzed ranged from 7–66 per generic brand (median: 18) and seven of the innovator. The proportion of generic formulations that failed to achieve a predefined clinical threshold activity of 50 IU/L ranged from 16.7% (2/12) to 84.9% (28/33) in the highest activity to lowest activity generic respectively. On other hand, all innovator samples had activity greater than 50 IU/L. In‐vitro asparaginase activity in the three generic formulations tested ranged from 71.4–74.6% of the label claim (10,000 IU) compared to 93.5% for the innovator. LC/MS analysis of generic 5 identified 25 HCPs with a relative peptide count of 27.1% of the total peptides. Conclusions Generic formulations had lower asparaginase activity which raises serious clinical concerns regarding their quality. Until stringent regulatory enforcement improves the quality of these generics, dose adaptive strategies coupled with therapeutic drug monitoring need to be considered.

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Section: Discussioncontrasting

confidence: 99%

A comparison of asparaginase activity in generic formulations of E.coli derived L‐ asparaginase: In‐vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia

Sankaran

Sengupta

Purohit

et al. 2020

Brit J Clinical Pharma

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Section: Methodsmentioning

confidence: 99%

“…122 InPOG is planning two additional prospective HL clinical trials 122 and has also opened a multicenter randomized trial in ALL that is currently enrolling. 123 InPOG has also collaborated with the Indian Pediatric Oncology Initiative to create the India Pediatric Oncology Database, a web-based database to facilitate hospital-based cancer registries and clinical trial research. 7,124,125 There is a long history of twinning in India, with the first collaborative relationship between the Cancer Institute in Chennai and the US NCI in the 1980s leading to the seminal MCP-841 pediatric ALL protocol, which tripled survival rates.…”

Section: Pediatric Oncology Clinical Trial Collaborative Groups By Re...mentioning

confidence: 99%

Mapping Pediatric Oncology Clinical Trial Collaborative Groups on the Global Stage

Major

Palese

Ermis

et al. 2022

JCO Global Oncology

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PURPOSE The global pediatric oncology clinical research landscape, particularly in Central and South America, Africa, and Asia, which bear the highest burden of global childhood cancer cases, is less characterized in the literature. Review of how existing pediatric cancer clinical trial groups internationally have been formed and how their research goals have been pursued is critical for building global collaborative research and data-sharing efforts, in line with the WHO Global Initiative for Childhood Cancer. METHODS A narrative literature review of collaborative groups performing pediatric cancer clinical research in each continent was conducted. An inventory of research groups was assembled and reviewed by current pediatric cancer regional and continental leaders. Each group was narratively described with identification of common structural and research themes among consortia. RESULTS There is wide variability in the structure, history, and goals of pediatric cancer clinical trial collaborative groups internationally. Several continental regions have longstanding endogenously-formed clinical trial groups that have developed and published numerous adapted treatment regimens to improve outcomes, whereas other regions have consortia focused on developing foundational database registry infrastructure supported by large multinational organizations or twinning relationships. CONCLUSION There cannot be a one-size-fits-all approach to increasing collaboration between international pediatric cancer clinical trial groups, as this requires a nuanced understanding of local stakeholders and resources necessary to form partnerships. Needs assessments, performed either by local consortia or in conjunction with international partners, have generated productive clinical trial infrastructure. To achieve the goals of the Global Initiative for Childhood Cancer, global partnerships must be sufficiently granular to account for the distinct needs of each collaborating group and should incorporate grassroots approaches, robust twinning relationships, and implementation science.

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Therapeutic drug monitoring informs asparaginase dose scheduling in the InPOG-ALL-15-01-ICiCLe-ALL-14 trial

Cited by 2 publications

References 0 publications

A comparison of asparaginase activity in generic formulations of E.coli derived L‐ asparaginase: In‐vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia

A comparison of asparaginase activity in generic formulations of E.coli derived L‐ asparaginase: In‐vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia

Mapping Pediatric Oncology Clinical Trial Collaborative Groups on the Global Stage

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