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A multicenter clinical cohort study: A retrospective analysis of the correlation between blood concentration and adverse reactions of high-dose methotrexate in the treatment of children acute lymphoblastic leukemia

A multicenter clinical cohort study: A retrospective analysis of the correlation between blood concentration and adverse reactions of high-dose methotrexate in the treatment of children acute lymphoblastic leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123807
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphocytic leukemia

Interventions

Case series:None

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients with bone marrow morphological diagnosis of ALL and immunological typing of ALL; 2. Age range of 1 month to 18 years; 3. Patients receiving HD-MTX therapy for the prevention of extramedullary leukemia; 4. Monitoring of MTX plasma concentrations at 24,48, and 72 hours post-administration; 5. Complete baseline data on complete blood count (CBC) and liver/kidney function tests prior to HD-MTX therapy.

Exclusion criteria

Exclusion criteria: 1. Secondary to immunodeficiency disorders; 2. Severe acute infections prior to HD-MTX chemotherapy; 3. Mature B-cell ALL and mixed phenotype leukemia (excluding ALL with myeloid antigen expression); 4. Second malignancy or confirmed acute exacerbation of chronic leukemia; 5. Various forms of intramedullary or extramedullary relapse; 6. Missing key study indicators in IIH collection.

Design outcomes

Primary

MeasureTime frame
Blood drug concentration;adverse reaction;

Countries

China

Contacts

Public ContactTu Yingqiu

The First Affiliated Hospital of Nanchang University

798783079@qq.com+86 791 8869 2733

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026