Flumatinib combined with autologous transplantation versus Dasatinib combined with autologous transplantation in the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia

A prospective, single-blind, randomized, controlled, single-center study of the safety and efficacy of flumatinib combined with autologous transplantation versus Dasatinib combined with autologous transplantation in the treatment of Philadelphia chromosome positive acute lymphoblemic leukemia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034270

Enrollment

Unknown

Registered

2020-06-30

Start date

2020-06-22

Completion date

Unknown

Last updated

2020-07-06

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

Conditions

Philadelphia chromosome positive acute lymphoblastic leukemia

Interventions

Flumatinib group:Flumatinib 600mg Po qd

Dasatinib group:Dasatinib 70mg po bid

Eligibility

Sex/Gender

All

Age

14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age from 14 to 65, regardless of gender; 2. ECOG score 0-2, estimated survival >= 6 months; 3. Newly diagnosed Ph+ALL; 4. Liver and kidney functions within 14 days before enrollment: TBIL <= 1.5 * ULN, ALT, AST <= 2.0*ULN, Cr <= 1.5*ULN; 5. Volunteer for the test and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiac insufficiency, with cardiac ejection fraction EF below 60%;Patients with severe arrhythmia or severe arrhythmia were evaluated as intolerant of preconditioning; 2. Patients with severe pulmonary dysfunction (obstructive and or restrictive ventilatory disorders) who could not tolerate the pretreatment regimen were evaluated. 3. Accompanied by severe liver function impairment, liver function indexes (ALT and TBIL) were more than 3 times higher than the upper limit of normal value (ULN);The researchers evaluated the patients who could not tolerate the pretreatment regimen.Pregnant and lactating women and people of childbearing age who are reluctant to use contraception; 4. With severe renal insufficiency, the renal function index (Cr) is more than 2 times of the upper limit of normal value (ULN); Or the 24-hour urinary creatinine clearance rate (Ccr) was lower than 50ml/min. 5. Patients with severe active infection before transplantation were evaluated by the researchers for their inability to tolerate the pretreatment with super high tolerance. 6. Patients with clinical symptoms of brain dysfunction or severe mental illness cannot understand or follow the study plan; 7. Women who are pregnant or preparing for pregnancy or lactation; 8. Patients with other malignant tumors requiring treatment; 9. Patients who are unable to ensure that necessary treatment plans and follow-up observations are completed.

Design outcomes

Primary

Measure	Time frame
overall survival;	—

Secondary

Measure	Time frame
Recurrence rate of CNSL;progression-free survival;Overall response rate;	—

Countries

China

Contacts

Public ContactXing hongyun

Department of Hematology, Affiliated Hospital of Southwest Medical University

393064897@qq.com+86 18283035160

Outcome results

None listed

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