Compared with patients with philadelphia chromosome-negative Acute Lymphoblastic Leukemia (Ph- ALL), patients with Ph-positive (Ph+) ALL exhibit a comparatively poor prognosis. Fortunately, significant improvements have been found in response rates, disease-free survival (DFS), and overall survival (OS) for patients with Ph+ ALL with the introduction of tyrosine kinase inhibitor (TKI) therapy to treatment regimens. Based on improvements in efficacy and tolerability, next-generation TKIs have been widely used in first-line treatment for chronic myeloid leukemia (CML). Flumatinib, a TKI with more potent binding affinity for BCR-ABL1 tyrosine kinase than imatinib, demonstrated higher rates of responses, faster and deeper responses in FESTnd trial, which suggested that flumatinib might show improved clinical efficacy for treating Ph+ ALL compared with imatinib. The investigators therefore hypothesized that the addition of flumatinib to combinatorial chemotherapy regimen would demonstrate greater efficacy compared with the prior use of imatinib in treating Ph+ ALL. This study explored the safety and efficacy of flumatinib versus imatinib when combined with multi-agent chemotherapy in patients with newly diagnosed Ph+ ALL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Flumatinib 600 mg qd will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Flumatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients in whom MCR was achieved within 3 months after treatment and continued until transplantation can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation and maintenance chemotherapy.
Imatinib 600 mg qd will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Imatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients in whom MCR was achieved within 3 months after treatment and continued until transplantation can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation and maintenance chemotherapy.
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Relapse free survival
From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day
Time frame: up to 24 months
The rate of adverse events
The incidence and severity of neutropenia, anemia, rash, hypophosphatemia, edema, limb pain, and other adverse events.
Time frame: through study completion, up to 24 months
The composite CR rate
Both CR and molecular CR are obtained at the end of induction
Time frame: up to 2 month
The complete remission (CR) rate,CRi rate and overall remission rate(ORR)
Time frame: up to 2 month
The minimal residual disease (MRD) negative rate by Flow Cytometry (FCM)
Time frame: up to 24 months
The molecular CR rate
Time frame: up to 6 months
The rate of primary induction failure(PIF)
Time frame: up to 6 months
The duration of molecular CR
Time frame: up to 24 months
The duration of CR
Time frame: up to 24 months
Time to treatment failure
Time frame: up to 24 months
The cumulative recurrence rate
Time frame: up to 24 months
The CNS recurrence rate
Time frame: up to 24 months
Event free survival(EFS)
Time frame: up to 24 months
Overall survival(OS)
Time frame: up to 24 months
The rate of interruption and discontinuation due to AE
Time frame: up to 24 months
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