• Daunorubicin, also known as daunomycin, is a chemotherapy medication used to treat cancer. (wikipedia.org)
  • Daunorubicin has been used with other chemotherapy agents to treat the blastic phase of chronic myelogenous leukemia. (wikipedia.org)
  • Doctors may use a combination of chemotherapy drugs, such as cytarabine, and an anthracycline drug, such as daunorubicin. (medicalnewstoday.com)
  • This phase involves providing a person with low doses of chemotherapy or other drugs for months to years. (medicalnewstoday.com)
  • A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL Rochester, Minn., Jacksonville, Fla. (mayo.edu)
  • EA9181, A Phase III Randomized Trial of Steroids+Tyrosine Kinase Inhibitor Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults Rochester, Minn. This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. (mayo.edu)
  • This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. (mayo.edu)
  • This tiny market cap biotech recently surprised investors with bullish phase 3 trial results for Vyxeos, a nano-scale liposome encased mash-up of the chemotherapy drugs cytarabine and daunorubicin, that sent shares surging 450%, and on Monday, the company updated investors on its timeline for regulatory filings for Vyxeos approval. (foxbusiness.com)
  • Approval of gemtuzumab ozogamicin in combination with chemotherapy for adults was based on ALFA-0701 (NCT00927498), a multicenter, randomized, open-label phase 3 study of 271 patients with newly-diagnosed, de novo AML aged 50 to 70 years. (fda.gov)
  • The Company is also conducting a series of studies to evaluate ziftomenib in combination with current standards of care, beginning with venetoclax/azacitidine and standard induction cytarabine/daunorubicin chemotherapy in NPM1-mutant and KMT2A-rearranged newly diagnosed and relapsed/refractory AML (KOMET-007). (abc4.com)
  • This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. (vicc.org)
  • Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, 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. (vicc.org)
  • CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. (vicc.org)
  • Chemotherapy is usually given in two main phases: (1) induction and (2) consolidation, which are explained in more detail below. (know-aml.com)
  • Induction chemotherapy is used in the first phase of treatment, it aims to kill abnormal leukemia cells and stop them from multiplying in the blood and bone marrow. (know-aml.com)
  • Another treatment used for induction chemotherapy is the combination of daunorubicin and cytarabine (CPX-351), which is approved in the United States and Europe to treat people with specific types of AML, including therapy-related AML and AML with myelodysplasia-related changes. (know-aml.com)
  • The consolidation phase involves further treatment with chemotherapy, often with the same drugs that were used in the induction phase. (know-aml.com)
  • Results from a phase 2 study showed that a 2-step induction regimen involving dasatinib and intensive chemotherapy was associated with high rates of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients younger than 65 years with Philadelphia chromosome-positive (Ph+), newly diagnosed acute lymphoblastic leukemia (ALL), as well as improved 3-year overall survival (OS) rates for those undergoing allo-HSCT compared with those who did not. (cancertherapyadvisor.com)
  • A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for. (sparkcures.com)
  • Therefore we conducted a phase 2 study, AML Len5 (ISRCTN58492795), to assess safety, tolerability and efficacy of lenalidomide monotherapy, followed by lenalidomide with intensive chemotherapy in patients with primary/relapsed/refractory high risk MDS or AML with abnormalities of chromosome 5. (ox.ac.uk)
  • PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia. (projectdatasphere.org)
  • For the study, patients were given either midostaurin or placebo in addition to standard daunorubicin/cytarabine chemotherapy during the induction stage. (incitasecurity.com)
  • Chemotherapy for AML is broken down into three phases: induction phase, consolidation (or intensification), and maintenance phase. (oncolink.org)
  • Oral lesions were associated with the induction phase of chemotherapy. (bvsalud.org)
  • In trials, overall survival in secondary acute myeloid leukemia (AML) patients receiving Vyxeos was 9.56 months and that was significantly better than the 5.95 months experienced within the control arm of the study, which was given the standard combination of cytarabine and daunorubicin. (foxbusiness.com)
  • Patients treated with CPX-351 had a median OS of 19.15 months as compared with 11.58 months for conventional formulations of cytarabine and daunorubicin. (medpagetoday.com)
  • Among future therapies, the researchers called CPX-351 (Vyxeos), a liposome formulation of cytarabine and daunorubicin, promising. (ajmc.com)
  • Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients. (fda.gov)
  • Patients were randomized (1:1) to receive induction therapy consisting of daunorubicin (60 mg/m2 on days 1 to 3) and cytarabine (200 mg/m2 on days 1 to 7) with (n=135) or without (n=136) gemtuzumab ozogamicin 3 mg/m2 (up to maximum of one vial) on days 1, 4, and 7. (fda.gov)
  • The first trial, AML-19, was a multicenter, randomized (1:1), open-label phase 3 study in 237 patients comparing gemtuzumab ozogamicin monotherapy to best supportive care (BSC). (fda.gov)
  • A liposomal formulation known as liposomal daunorubicin also exists. (wikipedia.org)
  • Median OS improved by almost 8 months among patients with AML and myelodysplasia-related changes (AML-MRC) treated with liposomal cytarabine-daunorubicin (CPX-351, Vyxeos) versus conventional 7 + 3 induction therapy, as reported at the Transplantation and Cellular Therapy Meetings . (medpagetoday.com)
  • Daunorubicin is in the anthracycline family of medication. (wikipedia.org)
  • Phase 2 Clinical Trial Evaluating the Safety, Tolerability, and Effectiveness of Venetoclax combined with Carfilzomib and Dexamethasone in Relapsed/Refractor. (sparkcures.com)
  • Phase 3 Clinical Trial comparing the use of venetoclax combined with dexamethasone versus Pomalidomide combined with dexamethasone in Relapsed/Refractory Mul. (sparkcures.com)
  • A Phase 1 Study of Adding Venetoclax to a Reduced Intensity Conditioning Regimen and to Maintenance in Comb. (sparkcures.com)
  • A Phase 1 Study of Triplet Therapy With Navitoclax, Venetoclax, and Decitabine for High-risk Myeloid Malign. (sparkcures.com)
  • A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/C. (sparkcures.com)
  • A Phase I/II Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or Hig. (sparkcures.com)
  • A Phase I/II Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patien. (sparkcures.com)
  • A Phase I/II Study of Venetoclax in Combination With ASTX727 (Cedazuridine/Decitabine) in Treatment-Naïve H. (sparkcures.com)
  • A Phase I/II Study of Venetoclax in Combination With Azacitidine in Relapsed/Refractory High-Risk Myelodysp. (sparkcures.com)
  • A Phase Ib/II Study Evaluating Navitoclax After Failure of Hypomethylating Agent and Venetoclax for Treatme. (sparkcures.com)
  • A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Aza. (sparkcures.com)
  • A Phase II Study of Venetoclax in Combination With 10-Day Decitabine in Newly Diagnosed Elderly or Relapsed. (sparkcures.com)
  • A Single-arm, Multi-center Phase II Trial of Bendamustine/Rituximab Induction Followed by Venetoclax and Ri. (sparkcures.com)
  • Pevonedistat with azacitidine in older patients with TP53-mutated AML: a phase 2 study with laboratory correlates. (doximity.com)
  • A Phase Ib/II Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AM. (sparkcures.com)
  • A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) Jacksonville, Fla., Rochester, Minn. (mayo.edu)
  • A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study) Rochester, Minn. This study seeks adult subjects with R/R Ph+ B-precursor ALL. (mayo.edu)
  • Vanderbilt was the lead site for an NIH-funded, phase 2, multicenter influenza vaccine study in pediatric allogeneic hematopoietic stem cell transplant (HCT) recipients that may lead to a change in the current flu vaccine recommendations in this vulnerable population. (vicc.org)
  • A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 Injection as Monotherapy or in Combina. (sparkcures.com)
  • Kura is also preparing to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with other targeted therapies, beginning with clear cell renal cell carcinoma (FIT-001). (abc4.com)
  • An Open-Label Phase 1a/1b Dose Escalation and Expansion Cohort Study of SL-172154 (SIRPα-Fc-CD40L) in Combi. (sparkcures.com)
  • Daunorubicin stabilizes the topoisomerase II complex after it has broken the DNA chain for replication, preventing the DNA double helix from being resealed and thereby stopping the process of replication. (wikipedia.org)
  • Plant alkaloids are mitotic spindle poisons active in G2 and M phases of cell division (vinca alkaloids, taxanes) or are topoisomerase interactive agents (etoposide and teniposide). (vin.com)
  • Phase I and II clinical trials) for patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) based on the underlying mutational drivers of each disease. (moffitt.org)
  • Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial. (doximity.com)
  • KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. (doximity.com)
  • MYLOTARG (gemtuzumabozogamicin) together with daunorubicin and cytarabine has been granted a positive opinion for the treatment of patient's age 15 years and above with previously untreated, de novo, CD33-positive acute chronic myelocytic leukemia (AML), except acute promyelocytic leukemia (APL). (medgadget.com)
  • Lenalidomide monotherapy and in combination with cytarabine, daunorubicin and etoposide for high-risk myelodysplasia and acute myeloid leukaemia with chromosome 5 abnormalities. (ox.ac.uk)
  • Novartis announced on Sunday, Dec. 6 that its Phase III RATIFY study for an acute myeloid leukemia (AML) drug called Midostaurin, showed promise in patients' survival rates. (incitasecurity.com)
  • Yes, I want to know moreMaintenance treatment for acute myelogenous leukemia with 4-week daunorubicin and daunorubicin plus cytarabine: a Southwest Oncology Group phase II study. (eldoradosapphirecompany.com)
  • We report the results of a phase II study of the same combination regimen administered for a 4-week cycle in patients with newly diagnosed acute myelogenous leukemia (AML). (eldoradosapphirecompany.com)
  • Principal supporting data for the approval came from the phase III QUAZAR AML-001 trial, a placebo-controlled trial involving 472 patients, ages 55 or older, with transplant-ineligible AML in first remission after standard induction therapy. (medpagetoday.com)
  • after a remission, you will enter this second phase of treatment. (oncolink.org)
  • Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. (ehealthme.com)
  • With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. (ehealthme.com)
  • With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. (ehealthme.com)
  • The landscape of relapsed pediatric AML treatment is changing rapidly, however, as the international AML community harnesses collective knowledge and resources to characterize the genetic and immunophenotypic heterogeneity of relapsed disease, identify biological targets of interest within specific AML subtypes, develop new precision medicine approaches for collaborative investigation in early-phase clinical trials, and tackle challenges of universal drug access across the globe. (haematologica.org)
  • The Children's Oncology Group (COG) in North America, Ireland, New Zealand, and Australia and other cooperative groups have viewed relapse as an opportunity to test novel therapeutic agents efficiently in smaller cohorts of patients via early-phase clinical trials. (haematologica.org)
  • The drug has been studied in Phase I and Phase II trials and found to have significant activity in CLL patients in general and in patients with unfavorable characteristics such as advanced age, adverse cytogenetics, and/or bulky disease. (peptide-solubility.com)
  • A Phase 1b/2 Study of BGB-11417 in Monotherapy and in Various Combinations With Dexamethasone and Carfilzom. (sparkcures.com)
  • A Phase I Study Investigating the Safety & Efficacy of Danvatirsen as Monotherapy Followed by Combination W. (sparkcures.com)
  • After the consolidation phase, some continued to receive either midostaurin or placebo for one more year. (incitasecurity.com)
  • A041501, A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL Rochester, Minn. (mayo.edu)
  • A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML (BMT CTN 1506) Rochester, Minn., Scottsdale/Phoenix, Ariz. (mayo.edu)
  • Conventional antileukemic therapy has limited efficacy in patients with BCR-ABL1 -negative MPNs in accelerated or blast phase of the disease. (ajmc.com)
  • Antimetabolites act during the S phase of the cell cycle, usually by mimicking normal purines and pyrimidines, which are the building blocks of DNA. (vin.com)
  • The second trial, MyloFrance-1, a phase 2, single-arm, open-label study, included 57 patients with CD33-positive AML in first relapse. (fda.gov)
  • Kura is currently enrolling patients in a Phase 2 registration-directed trial of ziftomenib in NPM1-mutant relapsed or refractory AML (KOMET-001). (abc4.com)
  • Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). (abc4.com)
  • The findings came from a subgroup analysis of a phase III trial involving 309 patients with newly diagnosed, high-risk secondary AML, including 246 who met World Health Organization criteria for AML-MRC. (medpagetoday.com)
  • Randomized Phase II Study of R-CHOP With or Without Bortezomib in Previously Untreated Patients With Non-Germinal Center B-Cell-Like Diffuse Large B-Cell Lymphoma. (sc-ctsi.org)
  • A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients Wi. (sparkcures.com)
  • Patients in the standard arm (surgery alone) will undergo large en- bloc curative intent surgery will be performed within 4 weeks following randomization. (who.int)
  • Small volumes of daunorubicin can be wrapped up in these minuscule pods, which can then be released into a leukemia cell-filled environment. (wikipedia.org)
  • BOSULIF (bosutinib) has been granted a positive opinion for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). (medgadget.com)
  • A Phase Ib /II Open-label, Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of APG-2575. (sparkcures.com)
  • The major causes of morbidity and mortality are usually thrombohemorrhagic events and less frequently infectious complications, and/or transformation to blast phase, often termed secondary AML or blast-phase MPN (MPN-BP). (ajmc.com)
  • There is no evidence that splenectomy plays a significant role during the chronic phase of CML. (rxmed.com)
  • The phase IV clinical study is created by eHealthMe based on 151 reports from the FDA, and is updated regularly. (ehealthme.com)