Decitabine, Venetoclax, and Ponatinib for the Treatment of Philadelphia Chromosome-Positive Acute...
Accelerated Phase Chronic Myelogenous LeukemiaBCR-ABL1 Positive9 moreThis phase II trial studies how well the combination of decitabine, venetoclax, and ponatinib work for the treatment of Philadelphia chromosome-positive acute myeloid leukemia or myeloid blast phase or accelerated phase chronic myelogenous leukemia. Drugs used in chemotherapy such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine, venetoclax, and ponatinib may help to control Philadelphia chromosome-positive acute myeloid leukemia or myeloid blast phase or accelerated phase chronic myelogenous leukemia.
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Myelodysplastic SyndromesChronic Myelocytic Leukemia2 moreStudy ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.
Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World...
Chronic Myeloid LeukemiaChronic Myeloid Leukemia3 moreThis is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.
PD-1 Inhibitor Combined With Azacytidine and Homoharringtonine,Cytarabine, G-CSF for Refractory...
ImmunotherapyRefractory Leukemia2 moreThis is an single center, single arm, phase 3 study to evaluate efficacy and safety of PD-1 Inhibitor combined with DNA methyltransferase inhibitor Azacytidine and HAG regimen for patients with relapsed and refractory acute myeloid leukemia.
huCART19-IL18 in CD19+ Cancers
Chronic Lymphocytic LeukemiaNon-hodgkin Lymphoma1 moreThe purpose of this study is to find the maximum dose of huCART19-IL18 cells that is safe for use in humans with CD19+ cancers.
Frontline Oral Arsenic Trioxide for APL
Acute Promyelocytic LeukemiaThe investigators have formulated an oral preparation of arsenic trioxide (oral-ATO), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients [8,9]. Furthermore, in an effort to prevent relapse, the investigators have moved oral-ATO forward to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS) [10], implying that prolonged treatment with oral-ATO may prevent relapses. Current protocols have incorporated i.v.-ATO in the treatment of newly-diagnosed APL [11-15]. For regimens comprising oral-ATO, ATRA and chemotherapy, 5-year OS in excess of 90% is achieved [11-15]. The investigators have also published long-term data showing the use of oral-ATO is highly effective and safe in the relapsed and frontline settings [16,17]. In this study, the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.
Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7...
T-cell Leukemia/LymphomaRefractory T Lymphoblastic Leukemia/Lymphoma1 moreThis is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.
CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
LeukemiaB-cell2 moreThis is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.
Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic...
Chronic Myelomonocytic LeukemiaMyelodysplastic SyndromeThis phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy drugs, such as venetoclax, cedazuridine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid...
Acute Myeloid LeukemiaThe Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B.