Clinical trials: Olverembatinib
Philadelphia Positive Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Adult
Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL.
- Trial name
- NCT06481228
- Testing
- CAR-T cells, Venetoclax, Olverembatinib
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), Childhood Leukemia, Acute Lymphoblastic
Newly-diagnosed Pediatric Ph-positive B-ALL Protocol
This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2…
- Trial name
- CAMS-Ph+ B-ALL (NCT07152041)
- Testing
- olverembatinib
- Where
- 24 sites in China, Hong Kong
- Volunteers
- 150 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
CML,Blast Phase
Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML
Even in the TKI era, the outcoms of patients with blast phase is still poor.The response rate to conventional intensive chemotherapy is only 12.5% and the 5-year survival rate is 0 for patients with myeloid blast crsis.
- Trial name
- NCT06757855
- Testing
- Olverembatinib, Venetoclax, Azacitidine
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation…
- Conditions
- Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase, Tyrosine Kinase Inhibitors
- Trial name
- NCT05311943
- Testing
- olverembatinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shenzhen Second People's Hospital
Myeloproliferative Neoplasm, Acute Leukemia
Olverembatinib for FGFR1-rearranged Neoplasms
FGFR1-rearranged myeloid/lymphoid neoplasms are a rare hematologic malignancy with very poor outcome despite intensive chemotherapy.
- Trial name
- NCT05521204
- Testing
- Olverembatinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Named Patient Program for Olverembatinib (HQP1351)
This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions…
- Trial name
- NCT05594758
- Testing
- Olverembatinib
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Myeloid Leukemia
Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase
This study is a multicenter observational study aimed to investigate the efficacy and safety of olverembatinib dose reduction to 20 mg every other day (QOD) in patients with chronic myeloid leukemia (CML) in chronic phase or…
- Trial name
- NCT07383298
- Testing
- Olverembatinib 20mg
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Qian Jiang
Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL
This is an open-label, multicenter, phase 1b study, which is designed to explore the safety, efficacy and PK of olverembatinib, a third-generation tyrosine kinase inhibitor (TKI) marketed in China, in combination with APG-2575 in…
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Relapsed Leukemia, Refractory Leukemia
- Trial name
- NCT05495035
- Testing
- Olverembatinib, APG-2575, Dexamethasone
- Where
- 4 sites in China
- Volunteers
- 19 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL
The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs.
- Trial name
- NCT05594784
- Testing
- Olverembatinib, Venetoclax, prednisone
- Where
- China
- Volunteers
- 79 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Philadelphia-Positive ALL
A Study of Olverembatinib in the Treatment of Ph+ ALL
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of a novel third-generation TKI Olverembatinib.
- Trial name
- NCT05466175
- Testing
- Olverembatinib, Prednisone, Vincristine
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Chen Suning
Chronic Myeloid Leukemia, CML
Study of Olverembatinib (HQP1351) in Patients With CML-CP
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A).
- Conditions
- Chronic Myeloid Leukemia, CML, CML, Chronic Phase
- Trial name
- POLARIS-2 (NCT06423911)
- Testing
- olverembatinib, Bosutinib
- Where
- 163 sites in United States, Australia and 14 more
- Volunteers
- 333 people
- Sponsor
- Ascentage Pharma Group Inc.
Philadelphia-Positive ALL
A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL
This is a multicenter, prospective, phase II study for adult de novo Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ ALL) based on the combination of Olverembatinib and Blinatumomab.
- Trial name
- NCT05931757
- Testing
- Olverembatinib
- Where
- China
- Volunteers
- 22 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Ph+ ALL, Bone Marrow Transplant
A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive
Hematopoietic stem cell transplantation (HSCT) is the effective and even the only cure treatment option for ph+ acute lymphocyte leukemia (ph+ALL).
- Conditions
- Ph+ ALL, Bone Marrow Transplant, Minimal Residual Disease
- Trial name
- NCT05603156
- Testing
- the usage of Olverembatinib combined with Inotuzumab Ozogamicin
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined…
- Trial name
- NCT06051409
- Testing
- Olverembatinib, Investigator's choice of TKI
- Where
- 90 sites in United States, Australia and 10 more
- Volunteers
- 350 people
- Sponsor
- Ascentage Pharma Group Inc.
Precursor B-Cell Acute Lymphoblastic Leukemia
Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults.
- Trial name
- NCT06754267
- Testing
- Venetoclax, Olverembatinib, Predinisone
- Where
- China
- Volunteers
- 36 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Acute Lymphoblastic Leukemia, Philadelphia Chromosome
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
- Conditions
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome, Philadelphia-Positive ALL, Adult ALL
- Trial name
- ABC (NCT06220487)
- Testing
- Prednisone, Olverembatinib, Blinatumomab, Chidamide
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Phase II Clinical Trial, Blinatumomab
Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)
To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.
- Conditions
- Phase II Clinical Trial, Blinatumomab, Olverembatinib, Lymphoblastic Leukemia
- Trial name
- NCT07178912
- Testing
- Blinatumomab, olverembatinib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), HSCT
Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL
This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell…
- Conditions
- Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), HSCT, Tyrosine Kinase Inhibitor
- Trial name
- NCT06658925
- Testing
- Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.
- Volunteers
- 50 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia
The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.
- Trial name
- NCT06082934
- Testing
- Olverembatinib plus venetoclax and dexamethasone
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xijing Hospital
Chronic Myeloid Leukemia, Chronic Phase
A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Chronic Phase With T315I Mutation
The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) harboring T315I mutation.
- Trial name
- NCT03883087
- Testing
- HQP1351
- Where
- 10 sites in China
- Volunteers
- 41 people
- Sponsor
- Ascentage Pharma Group Inc.