Chronic Myeloid Leukemia Clinical Trial
Official title:
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia
The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.
The preliminary analysis of the phase 1 clinical trial revealed evidence of clinical antitumor activity in patients with resistance to approved second-generation tyrosine kinase inhibitors (TKI), dasatinib and nilotinib, including patients with the T315I mutation of the BCR-ABL gene (BCR-ABL). This Phase 1 study, taken together with the strong preclinical data that characterize ponatinib, provides the rationale for moving to a pivotal phase 2 trial of this agent in a population of patients with chronic myeloid leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) who are resistant or intolerant to prior TKI therapy and in those patients with the T315I mutation. PACE is a multi-center, international, phase 2, uncontrolled, open-label trial of oral ponatinib in patients with Philadelphia chromosome-positive (Ph+) disease. The study enrolled 449 patients. Participants assigned to 1 of 6 cohorts in accordance with disease group and received: - Ponatinib 45 mg This multi-center trial is conducted worldwide. The overall time to participate in this study is 96 months after last dose of study drug treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
| Recruiting |
NCT03326310 -
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
|
Phase 1 | |
| Recruiting |
NCT04621851 -
Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
|
||
| Not yet recruiting |
NCT06409936 -
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
|
Phase 2 | |
| Active, not recruiting |
NCT02917720 -
2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients
|
Phase 2 | |
| Not yet recruiting |
NCT02883036 -
Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia
|
N/A | |
| Withdrawn |
NCT01188889 -
RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease.
|
Phase 1/Phase 2 | |
| Completed |
NCT01795716 -
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
|
Phase 1 | |
| Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
| Approved for marketing |
NCT00905593 -
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
|
Phase 3 | |
| Terminated |
NCT00573378 -
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
|
Phase 2 | |
| Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
| Completed |
NCT00469014 -
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
|
Phase 2 | |
| Completed |
NCT00257647 -
Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML)
|
N/A | |
| Unknown status |
NCT00598624 -
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
| Completed |
NCT00219739 -
STI571 ProspectIve RandomIzed Trial: SPIRIT
|
Phase 3 | |
| Completed |
NCT06148493 -
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
|
||
| Completed |
NCT00375219 -
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
|
Phase 2 | |
| Completed |
NCT04605211 -
A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors
|
N/A |