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Flumatinib combined with chemotherapy for adult Philadelphia chromosome/BCR-ABL1 positive acute lymphoblastic leukemia: a prospective study

Flumatinib combined with chemotherapy for adult Philadelphia chromosome/BCR-ABL1 positive acute lymphoblastic leukemia: a prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042248
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-01-18
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

adult Philadelphia chromosome/BCR-ABL1 positive acute lymphoblastic leukemia

Interventions

experimental group:flumatinib combined with chemotherapy

Sponsors

Shanghai Institute of Hematology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18-64 years; 2. Patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia; 3. Patients without serious heart disease or coronary heart disease history; 4. Patients with liver and kidney function suitable for chemotherapy: SGOT and SGPT should not exceed 2 times of the upper limit of normal; amylase and lipase in serum should not exceed 2 times of the upper limit of normal; total bilirubin in serum should not exceed 3 times of the upper limit of normal; 5. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. History of other cancers, except basal cell carcinoma; 2. With contraindications of corticosteroids; 3. Diabetes which cannot be successfully controlled; 4. HIV and syphilis-infected patients; 5. Pregnancy or lactating women; 6. Patients previously received an organ transplantation; 7. Severe neurological or psychiatric history.

Design outcomes

Primary

MeasureTime frame
progression free survival;overall survival;minimal residual disease;

Secondary

MeasureTime frame
complete remission;safety;mutation rate of Abl kinase domain;

Countries

China

Contacts

Public ContactJin Wang

Shanghai Institute of Hematology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

jinwang@shsmu.edu.cn+86 13524945202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026