Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05071482
Study type	Interventional
Source	Institute of Hematology & Blood Diseases Hospital
Contact	Jianxiang Wang, Dr.
Phone	86-22-23909120
Email	wangjx@medmail.com.cn
Status	Recruiting
Phase	Phase 4
Start date	September 16, 2021
Completion date	October 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05088356` - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft	Phase 1
Recruiting	`NCT04904588` - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	Phase 2
Recruiting	`NCT04969601` - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	Phase 1/Phase 2
Recruiting	`NCT02356159` - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation	Phase 1/Phase 2
Withdrawn	`NCT05170828` - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies	Phase 1
Terminated	`NCT02877082` - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients	Phase 2
Active, not recruiting	`NCT01956630` - Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT	Phase 1/Phase 2
Completed	`NCT00988013` - Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies	N/A
Enrolling by invitation	`NCT01728402` - Pathogenesis of Hematologic Malignancies
Active, not recruiting	`NCT03595800` - Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen	Phase 3
Completed	`NCT02440178` - Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia	Phase 2
Withdrawn	`NCT03138395` - iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML	N/A
Completed	`NCT03042676` - Electronic Database for the Follow up of the ATG_FamilyStudy
Completed	`NCT04597086` - Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients	N/A
Terminated	`NCT03588936` - Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant	Phase 1
Recruiting	`NCT05521204` - Olverembatinib for FGFR1-rearranged Neoplasms	Phase 2
Not yet recruiting	`NCT04084327` - Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
Terminated	`NCT00852709` - Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias	Phase 1
Not yet recruiting	`NCT06026839` - Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
Completed	`NCT00520130` - Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System	Phase 1/Phase 2