Clinical trial · Observational

Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation

NCT05837689CI-TRIAL-00066079unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the potential of using NGS to guide MRD eradication by blinatumomab.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Lymphoblastic Leukemia, Pediatric	Childhood Acute Lymphoblastic Leukemia	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Blinatumomab	Drug	Blinatumomab	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
MRD clearance rate (MRD<0.00001%)
timeFrame
before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment
description
The change of MRD will be detected by NGS, with sensitivity of 0.00001% and 0.01%, respectively

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 1 Year
Maximum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients diagnosed with B cell precursor acute lymphoblastic leukemia
* Patients who received blinatumomab for consolidation
* Patients who were detected MRD positive by NGS before initiation of blinatumomab treatment

Exclusion Criteria:

* Patients without data of NGS detection after receiving blinatumomab treatment

References

Publications (0)

Data not yet available

No reference posted for this study.