idarubicin hydrochloride / Generic mfg. - LARVOL DELTA

Venetoclax and Decitabine vs Intensive Chemotherapy as Induction for Young Patients with Newly Diagnosed AML. (PubMed, Blood) - P3 | "Patients aged 18-59 years eligible for intensive chemotherapy were randomized 1:1 to receive VEN-DEC or IA-12 (idarubicin and cytarabine). In conclusion, VEN-DEC demonstrated non-inferior response rates with superior safety over IA-12 in young AML patients. The trial was registered at ClinicalTrials.gov as #NCT05177731."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Thrombocytopenia • RUNX1 • RUNX1T1

Safety and Efficacy of G-CSF with Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia: A Subgroup Analysis of the Phase II Trial of Venetoclax in Combination with Cladribine, Idarubicin, and Cytarabine (ASH 2024) - P2 | "The trial allowed treating physicians to use filgrastim 300–480 µg daily for prolonged neutropenia or neutropenic fever; a trial amendment integrated pegfilgrastim at a dose of 6 mg SQ once between D5–9 of each cycle...Sixteen (18%) patients had FLT3-ITD — 8 (9%) received gilteritinib and 1 (1%) received midostaurin...FLT3-ITD AML was associated with delayed count recovery, likely due to concurrent TKI use. G-CSF use had no impact on the incidence of AML relapse."

Clinical • Combination therapy • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • ASXL1 • BCOR • BCR • FLT3 • KRAS • RUNX1 • SF3B1 • SRSF2 • STAG2 • U2AF1 • ZRSR2

Inotuzumab Ozogamicin Induction Followed By Standard Chemotherapy Yields High Remission Rates and Promising Survival in Older (>55 Years) Patients with De Novo B-Lymphoblastic Leukemia (GMALL-Initial1 Trial) (ASH 2022) - P2 | "The 1st induction cycle consisted of InO 0.8mg/m2 on day1 and 0.5mg/m2 on d8 and d15 together with dexamethasone 10 mg/m2 (day7-8, day14-17) and one intrathecal injection (i.th.) of methotrexate (MTX), cytarabine (AraC) and dexamethasone (Dex)...Pts achieving a complete remission (CR) were offered to receive 5 conventional consolidation therapies (3 x ID-MTX/asparaginase; 2 x ID-AraC) and one reinduction therapy (idarubicine/ AraC/ cyclophosphamide / Dex.) in combination with rituximab (for CD20+ ALL), followed by a maintenance therapy with 6-MP/MTX...So far, 7 pts with persisting/reappearance of MRD (2 pts) or relapse (5 pts) were treated with blinatumomab... Three cycles of InO as induction therapy for the treatment of older pts with de novo acute B-lymphoblastic leukemia resulted in a very high remission rate. Given that our study met the primary end point (predefined event rate at 1 year ≤40%, observed event rate 12%), these promising study results could be a..."

Clinical • Acute Lymphocytic Leukemia • Anemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Leukopenia • Oncology • T Acute Lymphoblastic Leukemia • Thrombocytopenia • ABL1 • BCR • CD20 • CD22

AML16: A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=206 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Trial primary completion date: Jun 2025 ➔ Sep 2025

Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Arsenic Trioxide and All-Trans Retinoic Acid Combination Therapy for the Treatment of High-Risk Acute Promyelocytic Leukemia: Results From the APOLLO Trial. (PubMed, J Clin Oncol) - P3 | "The results of the APOLLO trial support the use of ATO and ATRA for the treatment of newly diagnosed patients with high-risk APL."

Journal • Acute Promyelocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology

Outcomes in patients with newly diagnosed Acute Myeloid Leukemia with KMT2A rearrangement treated with cladribine, idarubicin, cytarabine (CLIA) with or without venetoclax (ASH 2025) - P2 | "The 2-year EFS was 81% and 50% for CLIA-Ven and CLIA, respectively (HR 0.28, p=0.09).The 2-year OS was 81% and 50% for CLIA-Ven and CLIA, respectively (HR 0.37, p=0.19).There were a total of 3 deaths in the CLIA arm: 1 death was treatment related mortality on day 10 of firstcycle of the CLIA due to DAH and intracranial bleed and two deaths were secondary to relapsed disease.There were 3 deaths in CLIA-Ven arm: 1 death was due to severe COVID-19 related complication after 2cycles of chemo, 1 death due to infectious complications 21 days post Allo SCT and 1 death was due torelapsed disease. ConclusionAmong young and fit patients with newly diagnosed AML with KMT2Ar, IC with CLIA induced high rates ofMRD negative remissions, allowing a majority of patients to proceed with a potentially curative alloSCT.The addition of venetoclax with CLIA appeared to produce a higher rate of MRD negative completeremission, low rate of relapse, and promising long term survival in a high..."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • CDKN1A • KMT2A • KRAS • NRAS • TET2

Multicenter prospective phase II study of decitabine priming with low-dose idarubicin, cytarabine, and G-CSF in children with refractory or relapsed acute myeloid leukemia. (PubMed, Haematologica) - "No standard salvage regimen exists for relapsed/refractory (R/R) pediatric AML. In this prospective, multicenter Phase II trial, 101 evaluable patients."

Journal • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

FLAG-VENETOCLAX-ENASIDENIB SALVAGE FOR 7+3 FAILURE (EBMT 2026) - "The patient underwent standard induction with the "7+3" regimen (Cytarabine/Idarubicin) plus venetoclax...Consequently, a salvage regimen comprising FLAG (Fludarabine, Cytarabine, G-CSF), venetoclax, and the IDH2-inhibitor enasidenib (100 mg daily) was initiated... This case demonstrates that NGS is indispensable in the management of refractory AML-MRC, specifically for identifying targets like IDH2 when standard venetoclax-based induction fails. The addition of enasidenib to FLAG-based salvage provided a crucial bridge to transplant. Furthermore, for patients who have failed intensive induction, NMA conditioning offers a viable, reduced-toxicity platform for allogeneic HSCT, allowing for successful engraftment and survival in a resource-limited setting."

IO biomarker • Acute Myelogenous Leukemia • B Cell Lymphoma • Bone Marrow Transplantation • Hematological Disorders • Leukemia • Lymphoma • Myelodysplastic Syndrome • ASXL1 • RUNX1 • SRSF2

LATE-ONSET DONOR-DERIVED PDGFR-Β–REARRANGED EOSINOPHILIC NEOPLASM FOLLOWING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN A SECONDARY ACUTE MYELOID LEUKEMIA (EBMT 2026) - " A 60-year-old female with high-risk myelodysplastic syndrome that transformed to AML achieved complete remission after induction chemotherapy with idarubicin, cytarabine, and venetoclax, followed by consolidation therapy. This case represents a rare example of late-onset donor-derived PDGFR-β–rearranged eosinophilic neoplasm following haploidentical allo-HSCT. Clinically silent donor clones may exist despite normal donor blood counts and can expand after engraftment under altered immune and hematopoietic conditions. Persistent eosinophilia occurring beyond six months post-transplant warrants molecular evaluation for clonal disorders, even in the presence of complete donor chimerism and sustained remission, to ensure accurate diagnosis and enable timely targeted therapy."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Eosinophilia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hypereosinophilic Syndrome • Immunology • Leukemia • Myelodysplastic Syndrome • Transplantation • FLT3 • IDH2 • KMT2A • PDGFRB

SUCCESSFUL MANAGEMENT OF POST-TRANSPLANT AML RELAPSE WITH SALVAGE CHEMOTHERAPY AND DONOR LYMPHOCYTE INFUSION (EBMT 2026) - "Complete remission was achieved after induction chemotherapy with 3+7 (idarubicin, cytarabine (ara-C)). Following consolidation with high-dose ara-C, the patient underwent sibling-matched allogeneic HCT with a myeloablative conditioning regimen (busulfan/fludarabine/ATG). Methotrexate, ATG, and cyclosporine were administered as graft-versus-host disease (GvHD) prophylaxis...HAM (high-dose ara-C, mitoxantrone) chemotherapy was administered due to relapse of AML after transplantation...If a mutation is identified through genetic testing, targeted therapies or venetoclax can be combined... The prognosis for patients with relapsed AML after allogeneic SCT is poor, with a two-year overall survival rate below 20%. There is no established standard treatment for relapse post-transplantation. To reduce tumor burden, intensive chemotherapy is recommended for fit patients, while low-intensity chemotherapy or hypomethylating agents are suggested for unfit patients."

IO biomarker • Post-transplantation • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Transplantation • FLT3 • TP53

SUCCESSFUL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR NEWLY DIAGNOSED AND RELAPSED/REFRACTORY ACUTE MYELOBLASTIC LEUKEMIA FOLLOWING A HIGHLY EFFICIENT REGIMEN, FLAG-MITOXANTRONE WITH LOW-DOSE 7 DAYS VENETOCLAX (EBMT 2026) - "Background: FLAG (G-CSF, Fludarabine, Cytarabine) combined with either Idarubicin (Ida) or Mitoxantrone (Mitox) are effective and well tolerated in newly diagnosed (ND) or relapsed/refractory (R/R) Acute Myeloblastic Leukemia (AML)(Burnett et al...FLAG-Mitox +Ven combined G-CSF (5μg/kg/d) on d1-7, Fludarabine (30mg/m2/d IV), and Cytarabine (1.5g/m2/d IV) on d2-5, Mitox (12mg/m2/d IV) d2,4 and Ven (100mg PO daily) given with voriconazole d2-8...Among the 50 R/R pts, first induction therapy consisted of 7+3 regimen in 32 pts (64%), FLAG-Ida in 15 pts (30%) and 5-Azacytidine+Ven in 3 pts (6%)... FLAG–Mitox+Ven (7d) is a highly-effective and well-tolerated for remission induction and MRD negativity in ND and R/R AML pts. High survival outcomes were demonstrated across ELN 2022 risk groups in ND AML pts. This regimen is also an effective bridge to AHSCT."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Pneumonia • Respiratory Diseases • Transplantation • FLT3

A CASE OF CAPILLARY LEAK SYNDROME FOLLOWING HAPLOIDENTICAL ALLOGENEIC STEM CELL TRANSPLANTATION IN A PATIENT WITH ACUTE MYELOID LEUKEMIA (EBMT 2026) - "She achieved remission with incomplete hematologic recovery after induction therapy with cytarabine and idarubicin, followed by a combination of azacitidine, venetoclax, and gilteritinib...The stem cell recipient underwent reduced-intensity conditioning with thiotepa (5 mg/kg), fludarabine (120 mg/m²), and busulfan (5.5 mg/kg)...Post-transplant cyclophosphamide (40 mg/kg) was given on day +3 for graft-versus-host disease (GVHD) prophylaxis, after which she developed new-onset arrhythmia and hemorrhagic cystitis...Due to the refractoriness of the patient's CLS and her rapid clinical deterioration, 1 dose of bevacizumab 5 mg/kg was given... This case highlights the diagnostic and therapeutic challenges in patients who develop fatal CLS post-HSCT. Because its clinical features frequently overlap with other post-HSCT complications, maintaining a high index of suspicion is crucial in the timely recognition and management of this rare syndrome. The lack of standard..."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hypertension • Hypotension • Immunology • Leukemia • Respiratory Diseases • Transplantation • CD34 • DEK • FLT3 • NUP214

ARCHIVE CONDITIONING (ALKYLATING AGENTS, CYTARABINE, CLADRIBINE, HYPOMETHYLATING AGENTS, AND VENETOCLAX) FOR UPFRONT ALLOGENEIC STEM CELL TRANSPLANTATION IN NEWLY DIAGNOSED OR RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (EBMT 2026) - "The patients were 18 years or older, had AML or MDS/AML with >5% blasts and/or extramedullary disease, and were alloSCT-eligible.ARCHIVE conditioning regimen (Picture 1) consisted of cytarabine 500 or 1000 mg/m2, cladribine 5 mg/m2 on days -8, -7, -6, -5, -4, venetoclax 600 mg/d and decitabine 20 mg/m2 / azacitidine 75 mg/m2 on days -8, -7, -6, -5, -4, -3, -2. The backbone alkylating agent was either busulfan (3.2 mg/kg on days -3 and/or -2) or melphalan (100 mg/m2 on day -2 in patients with previous busulfan exposure and/or TP53-mutated disease), whereas thiotepa was added to busulfan or melphalan in selected cases...GVHD prophylaxis consisted of cyclophosphamide 40 mg/kg (days +3, +4), calcineurin inhibitor, and mycophenolate mofetil.We collected baseline characteristics, CR+CRp rate at day +30, MRD negativity rate (by MFC and PCR), time-to-engraftment, grade 3-5 non-hematological toxicity (CTCAE v5.0), OS, and RFS.Picture 1. ARCHIVE conditioning regimen Thirty-two..."

Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Graft versus Host Disease • Hepatology • Immunology • Mucositis • Transplantation • FLT3 • TP53

CPX-351 in Down syndrome-associated Myeloid Leukemia: Results and Prognostic Factors from the Phase 3 ML-DS 2018 Trial. (PubMed, Blood) - P3 | "Intensity-reduced induction and reinduction therapy with cytarabine, idarubicin ± etoposide of the ML-DS 2006 trial was replaced with CPX-351 (66 U/m² on three days in course 1 and two days in course 2)...In conclusion, replacing intensity-reduced induction therapy with CPX-351 in ML-DS resulted in significantly lower event-free survival, highlighting the need for dose optimization to balance efficacy and toxicity in this sensitive patient population. EudraCT: 2018-002988-25."

Biomarker • Journal • P3 data • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Oncology • GATA1

Venetoclax plus intensive chemotherapy with cladribine, idarubicin, and cytarabine in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome: a cohort from a single-centre, single-arm, phase 2 trial. (PubMed, Lancet Haematol) - P2 | "Venetoclax added to CLIA was safe and active in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome, producing high rates of durable MRD-negative remissions and encouraging event-free survival and overall survival."

Clinical • IO biomarker • Journal • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • FLT3

Venetoclax-based regimens versus intensive chemotherapy in fit older adults with newly diagnosed acute myeloid leukemia (AML):a multicenter, prospective, randomized phase II trial (ASH 2025) - P=N/A | "Thismulticenter, randomized phase II study (NCT06066242) compared efficacy and safety of differentinduction therapies. Patients aged 60–75 years with newly diagnosed, non-M3/CBF AML fit for IC were randomized1:1:1 (Oct 2023–Jan 2025) to: Arm A (IC): Standard "3+7" (D/IA: daunorubicin 60mg/m² or idarubicin 10mg/m² d1-3, cyctarabine 100mg/m² d1-7)Arm B (VA): Ven (100mg d1, 200mg d2, 400mg d3-21/28; on day21, a bone marrow aspiration will be performed...Two cycles of intermediate-dose cytarabine consolidation(cyctarabine 1g/m² q12h d1,3,5), followed by maintenance: 2 cycles of DA/IA (daunorubicin 30mg/m² oridarubicin 8mg/m² d1-2, cyctarabine 100mg/m² d1-5) and 4 cycles of VA (Ven 400mg d1-7, AZA 75mg/m²d1-5)... No significant differences in survival were observed across three regimens. CRc rates weresimilar between VA and D/IAV regimen, which shows trend better than D/IA. VA improvedsurvival compared to D/IA in..."

Clinical • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Neutropenia

Olutasidenib in post-venetoclax patients with mIDH1 AML. (ASCO 2023) - P1/2 | "VEN was used with azacytidine (AZA) in 8 patients, after AZA (1), and with decitabine (5), cytarabine +/- idarubicin (5), and dinaciclib (2). Olutasidenib induced durable remissions in patients with mIDH1 R/R AML, including those failing prior treatment with a venetoclax-based regimen. Clinical trial information: NCT02719574."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • IDH1

A Randomized Comparison of CPX-351 and FLAG-Ida in Patients with High-Risk Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) and MDS-Related Gene Mutations: A Subgroup Analysis of the UK NCRI AML19 Trial (ASH 2024) - "FLAG-Ida consisted of fludarabine 30 mg/m2 and cytarabine 2 g/m2 on days 2-6 (reduced to 1 g/m2 in patients >60 years), lenograstim 263 µg on days 1-7, and idarubicin 8 mg/m2 on days 4-6; consolidation regimens were MACE-MiDAC...A more favorable toxicity profile may have resulted in higher number of patients in CPX-351 arm getting to transplant. Post-transplant OS was longer with CPX-351 compared with FLAG-Ida."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Septic Shock • Thrombocytopenia • ASXL1 • BCOR • RUNX1 • SF3B1 • SRSF2 • STAG2 • TP53 • U2AF1 • ZRSR2

High Response and Prolonged Treatment-Free Remission after a Short-Course of Modified Intensive Chemotherapy and Venetoclax in Elderly AML: An Updated Analysis of the Caveat Trial (ASH 2022) - "Background Venetoclax (VEN) plus azacitidine has an established role in the management of older patients (pts) with AML (DiNardo, NEJM 2020)...We now present an updated analysis of this trial (with >3 years median follow-up), reporting on the optimal dose of VEN with chemotherapy, with and without posaconazole (POSA), the deliverability of consolidation therapy, characteristics of treatment failure and observation of substantial treatment-free remission in subsets of pts using this time-limited, short-course regimen...For induction, VEN was administered over 14 days, commencing with a 7-day pre-chemo dose ramp-up, followed by a 7-day overlap with 5+2 chemotherapy (cytarabine 100mg/m2/d IVI d1-5 and idarubicin 12mg/m2 IV d2-3)...Induction with VEN-POSA (n=18) was also well tolerated (30-day mortality 0%) with 3 DLTs observed: 2 hematologic (1 in each cohort) and 1 due to pulmonary infiltrates occurring on d2 induction (suspected to be allopurinol..."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • Immunology • FLT3 • IDH2 • KIT • NPM1

Final Analysis of the Phase 1b Chemotherapy And Venetoclax in Elderly Acute Myeloid Leukaemia Trial (CAVEAT). (PubMed, Blood Adv) - P1/2 | "Venetoclax plus azacitidine represents a key advance for older, unfit patients with acute myeloid leukemia (AML)...The CAVEAT induction combined cytarabine and idarubicin with 5 dose levels of venetoclax (50-600 mg) for up to 14 days. Two additional cohorts explored adjusted-dose venetoclax (50 mg, 100 mg) with posaconazole...CAVEAT represents an effective time-limited treatment option for fit older patients with AML. (https://www.anzctr.org.au; ACTRN12616000445471)."

Journal • P1 data • Acute Myelogenous Leukemia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Gimema AML1718 Part 1: Planned Interim Analysis of a Safety Run-in and Phase 2 Open-Label Study of Venetoclax, Fludarabine, Idarubicin and Cytarabine (V-FLAI) in the Induction Therapy of Non Low-Risk Acute Myeloid Leukemia (ASH 2022) - P2 | "VEN dose was under situations of concomitant posaconazole administration, discontinued until recovery for patients in remission at day 21 and during consolidation courses; post HSCT maintenance were not allowed. V-FLAI administration was associated with a high and promising CR rate and prolonged OS duration in an intermediate- and high-risk population, without any safety signals. Preliminary MRD analysis revealed deep responses in most of the patients that translated to favorable 1-year survival. The confirmatory arm at the lower effective dosage (VEN 400 mg in combination with FLAI) with centralized MRD assessment is ongoing."

Clinical • P2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Transplantation • FLT3 • IDH1 • IDH2

Case Report: FIA plus venetoclax in a patient on hemodialysis. (PubMed, Front Oncol) - "The safe and effective delivery of curative cytotoxic chemotherapy for acute myeloid leukemia (AML) in patients receiving intermittent hemodialysis (IHD) for end-stage renal disease (ESRD) remains a clinical challenge; pharmacological and logistical barriers necessitate close interdisciplinary coordination. In this case, we report a 65-year-old female patient with chronic ESRD on IHD and newly diagnosed AML who achieved complete remission (CR) after treatment with fludarabine, idarubicin, and cytarabine plus venetoclax (i.e., FIA + venetoclax)."

Journal • Acute Myelogenous Leukemia • Chronic Kidney Disease • Hematological Disorders • Hematological Malignancies • Leukemia • Nephrology • Oncology • Renal Disease

OUTCOMES OF ADULT PATIENTS WITH NEWLY DIAGNOSED IDH-MUTATED ACUTE MYELOID LEUKEMIA RECEIVING INTENSIVE CHEMOTHERAPY PLUS VENETOCLAX (EHA 2025) - P1/2, P2 | "This was a retrospective pooled analysis of two clinical trials of cladribine, idarubicin, and cytarabine + VEN (CLIA+VEN, NCT02115295) and fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin + VEN (FLAG-IDA+VEN, NCT03214562). Venetoclax combined with IC results in a high rate of MRD-negative remissions and impressive OS in newly diagnosed, IDH-mutated AML. IDH1-mutated AML had lower response rates and OS, possibly due to a higher proportion of concurrent adverse cytomolecular features. Randomized trials are needed to determine the optimal induction regimen for patients with IDH mutations."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1

Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet) - P3 | "The addition of quizartinib to standard chemotherapy with or without allo-HCT, followed by continuation monotherapy for up to 3 years, resulted in improved overall survival in adults aged 18-75 years with FLT3-ITD-positive newly diagnosed AML. Based on the results from the QuANTUM-First trial, quizartinib provides a new, effective, and generally well tolerated treatment option for adult patients with FLT3-ITD-positive newly diagnosed AML."

Journal • P3 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Transplantation • FLT3

Safety Run-In and Part 1 of GIMEMA AML1718: Venetoclax Combined with FLAI as Induction Treatment in Non-Low-Risk AML. (PubMed, Blood Adv) - P2 | "We conducted a multicenter study phase 1b/2, GIMEMA AML1718, to investigate the safety and efficacy of venetoclax (VEN) combined with fludarabine, cytarabine, and idarubicin (V-FLAI) as an induction therapy for non-low-risk AML patients younger than 65 years and at intermediate or high ELN risk. Fifty-five more patients will be enrolled in part 2; they will receive VEN 400 mg-FLAI as predefined and will be centrally evaluated for measurable residual disease. NCT03455504."

Clinical • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology