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A clinical study investigating the Protocol ZJCH-ALL-R1 with bortezomib in the treatment of relapsed childhood acute lymphoblastic leukemia

A clinical study investigating the Protocol ZJCH-ALL-R1 with bortezomib in the treatment of relapsed childhood acute lymphoblastic leukemia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045759
Enrollment
Unknown
Registered
2021-04-24
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

childhood acute lymphoblastic leukemia

Interventions

Sponsors

The Children‘s Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1.Aged 1 to 16 year; 2.Bone marrow juvenile cells > 20% in ALL patients with first bone marrow recurrence; Or patients with a first combined relapse of ALL with > 5% juvenile cells in bone marrow and at least one extramedullary relapse (meningeal leukemia relapse: CSF white blood cell count > 5 /µL with juvenile cells; Testicular leukemia recurrence: confirmed by B ultrasound or biopsy).

Exclusion criteria

Exclusion criteria: 1.Second tumor; 2.Myeloid relapse or diphenotypic relapse; 3.Severe organ dysfunction, such as serious diseases of the heart, liver, kidney and nervous system; 4.Vital signs unstable; 5.Other situations which the investigators consider the patient is unsuitable for participation in the study; 6.Patients have undergone hematopoietic stem cell transplantation.

Design outcomes

Primary

MeasureTime frame
Peripheral blood was not restored to remission;Complete response rate;Overall survival;Event-free survival;Detection of leukemic minimal residual disease (MRD);

Countries

China

Contacts

Public ContactLiao Chan

The Children's Hospital of Zhejiang University School of Medicine

liaochan@zju.edu.cn+86 13805759156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026