Treatment Free Remission (TFR) in CML Patients (CML-CP)Study
Chronic Myeloid LeukemiaTreatment-free RemissionImproving the quality of life and achieving Treatment-Free Remission(TFR) is a long-term goal of treatment in CML-CP patients, and deep molecular response (DMR) is necessary to achieve TFR. Cording to the historical literature, it is reported that patients with CML-CP take MMR as the therapeutic target, and the acquisition rate of DMR under long-term TKI treatment is 50%. The 2-year success rate of TFR patients was 50%. Therefore, maybe only 25% of patients with CML can successfully stop the drug for a long time. It cannot meet the withdrawal needs of patients with long-term drug survival. This study is to design a real-world observational registration study for optimal effect. On the premise of taking DMR as the target decision, through initial treatment intervention, improve the DMR rate, which will promote clinical practice, so as to improve the 2-year TFR rate of cml-cp patients. This study is a multicenter, observational, prospective registry to identify the optimal treatment for achieving TFR in CML patients. In this study, the investigators will assess the deep molecular response after 12 months of treatment and the 2-year treatment-free remission rate (TFR 2y) after drug discontinuation. Eligible participants with CML-CP can be enrolled. The observation period of all participants is at least 60 months, of which the first 36 months is the shortest treatment period, and the last 24 months is the TFR observation period after TKIs (Imatinib/Flumatinib/Nilotinb/ Dasatinib) withdrawal. During the treatment phase, participants can receive TKIs ± IFN (or other treatments) as first-line/second-line treatment, and the treatment plan will be adjusted according to the molecular response. Patients should accept TKI treatment for at least 3 years or more, and MR4/MR4.5 should achieve at least 2 years before discontinuation.
A Bioequivalence Study of Dasatinib Tablet
LeukemiaMyelogenous1 moreThis is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Sprycel® produced by Bristol Myers Squibb after single dose in healthy subjects, so as to provide reference for clinical evaluation and clinical medication; to observe the safety of the dasatinib tablet and the reference drug Sprycel® in healthy subjects under fasting and fed states.
Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft...
Myelodysplastic SyndromeChronic Myelomonocytic Leukemia12 moreTo see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.
Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic...
Acute Lymphoblastic LeukemiaAcute Myelogenous Leukemia4 moreThis clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched related donors for children and young adults with hematologic malignancies who lack a suitably matched related or unrelated donor. The methodology will be one that has been successfully utilized in adult patients at Thomas Jefferson University.
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and...
Chronic Myeloid LeukemiaGastrointestinal Stromal TumorInvestigational Product Imatinib mesylate tablet 400 mg Glivec film-coated tablet 100 mg (Comparator) Expected target disease chronic myeloid leukemia Gastrointestinal stromal tumors Study design : Randomized, open-label, single dose, two-period, two-way, crossover study 36 healthy subjects, 2 groups (18 subjects/group) 2 Period (either 1-a(1 tablet) or 1-b(4 tablet)) wash-out period : 14 days Evaluation on pharmacokinetics(PKs) and safety PKs : Cmax, AUClast, Tmax, AUCinf, t1/2 safety : adverse events, physical examination, vital sign, ECG, Laboratory test Statistical method Demography Characteristics Pharmacokinetic parameters Safety data
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid...
Accelerated Phase Chronic Myelogenous LeukemiaBCR-ABL1 Positive16 moreThis phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan and fludarabine phosphate, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia...
Chronic Myelogenous LeukemiaThe aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated...
Chronic Myeloid LeukemiaThe purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
Acute Myeloid LeukemiaMyelodysplastic Syndromes8 moreThe primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib...
Chronic Myeloid LeukemiaThe purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.