idarubicin hydrochloride / Generic mfg. - LARVOL DELTA

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

Phase II study of cladribine, idarubicin, and ara-C (CLIA) with or without sorafenib as initial therapy for patients with acute myeloid leukemia. (PubMed, Am J Hematol) - "CLIA was safe and effective in young, fit patients with newly diagnosed AML with inferior outcomes among patients with ts-AML. The addition of sorafenib to CLIA in FLT3-ITD mutated AML resulted in high rates of durable remission and excellent long-term survival."

Journal • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • FLT3

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

Cardiovascular and Survival Outcomes Among Adults With Hematologic Malignancies Receiving Anthracyclines With vs Without Dexrazoxane: A Real-World Propensity-Matched Analysis (SOHO 2026) - "Patients: Adults aged 18–75 years with a hematologic malignancy (ALL; AML; CLL; CML; Hodgkin lymphoma; DLBCL; follicular, mantle cell, or mature T/NK lymphoma; multiple myeloma; MDS; polycythemia vera) diagnosed on/after January 1, 2010, initiating an anthracycline (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone) within 3 months of diagnosis, with (n = 1887) or without (n = 40607) concurrent dexrazoxane. Dexrazoxane was paradoxically associated with higher cardiomyopathy, heart failure, MACE, and mortality, contrary to randomized cardioprotection trials. These results almost certainly reflect channeling bias: dexrazoxane is preferentially given to patients receiving high cumulative anthracycline doses or with preexisting/emerging cardiotoxicity, which are not captured by administrative coding. ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, CLL: chronic lymphocytic leukemia, CML: chronic myeloid leukemia, DLBCL: diffuse large B-cell..."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Polycythemia Vera

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

Venetoclax plus modified-intensity Idarubicin and Cytarabine treatment as first-line treatment for newly diagnosed pediatric acute myeloid leukemia. (PubMed, Clin Cancer Res) - "VIA regimen is highly effective and relatively safe in children with ND-AML, with deep remission and favorable survival outcomes."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Pediatrics • Transplantation • KIT • RUNX1 • RUNX1T1

FLAsH-IV-AML: Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=26 | Not yet recruiting | Sponsor: Christer C Nilsson

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

PRELIMINARY RESULTS OF QUIWI: A DOUBLE BLINDED, RANDOMIZED CLINICAL TRIAL COMPARING STANDARD CHEMOTHERAPY PLUS QUIZARTINIB VERSUS PLACEBO IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD WILD-TYPE AML (EHA 2023) - P2 | "The randomized SORAML trial from the SAL group, including FLT3-ITD mutated and WT, showed that the addition of type II inhibitor sorafenib improved leukemia-free, but not overall survival (OS) among newly diagnosed fit AML patients...The trial was conducted in two phases: an open-label safety run-in phase exploring Cytarabine 200 mg/m 2 (days 1-7), Idarubicin 12 mg/m 2 (days 1-3), and Quiz 60 mg/d x 14 days to establish the dose for the randomized phase... Our study suggests that the addition of Quiz to 3+7 may prolong OS in newly diagnosed FLT3-ITD WT AML. A large biomarker plan to clarify underlying molecular mechanisms and final analyses with longer follow-up will be reported by the end of 2023. flt3 inhibitor, Treatment, Clinical trial, Acute myeloid leukemia"

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • NPM1

Clinical Outcomes of Adults With Core Binding Factor Acute Myeloid Leukemia (CBF‑AML): A Single Center Experience (SOHO 2023) - "Other regimens included: cladribine, idarubicin and cytarabine (CLIA, n=1), fludarabine, cytarabine and gemtuzumab ozogamicin (FLAG-GO, n=1), idarubicin and cytarabine (3+7 regimen, n=1) and decitabine, venetoclax and GO (n=1). Although CBF-AML is considered a favorable risk AML, outcomes for relapsed disease remains poor. Incorporation of GO and CD117 tyrosine kinase inhibitors (i.e. dasatinib) into induction and consolidation regimens may mitigate the relapse risk and improves long-term outcomes."

Clinical • Clinical data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KIT

Cladribine, idarubicin, and cytarabine (CLIA) for patients with relapsed and/or refractory acute myeloid leukemia: A single-center, single-arm, phase 2 trial. (PubMed, Cancer) - P2 | "CLIA is effective for patients with R/R AML and offers a safety profile similar to that of other intensive regimens (ClinicalTrials.gov identifier NCT02115295)."

Journal • P2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Transplantation • FLT3

FLAG-IDA + venetoclax in newly diagnosed (ND) or relapsed/refractory (RR) AML. (ASCO 2024) - P1/2 | "Induction comprised fludarabine 30mg/m 2 D2–6, cytarabine 1.5g/m 2 D2–6, idarubicin 8 (6 if RR) mg/m 2 D4–6 & filgrastim 5mcg/kg D1–7. FLAG-IDA+VEN results in high MRD negative response rates, leading to impressive survival outcomes across ELN risk groups in ND AML. It is an effective salvage regimen for RR AML, especially for S1+TP53 WT pts."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Gastrointestinal Disorder • Infectious Disease • Septic Shock • Transplantation • TP53

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

A Rare Case of ZBTB16::RARA Fusion Acute Myeloid Leukemia Mimicking Acute Promyelocytic Leukemia: Diagnostic Challenges and Successful CLIA + Venetoclax Therapy (SOHO 2026) - "The zinc finger and BTB domain-containing 16 (ZBTB16):: retinoic acid receptor alpha (RARA) fusion, also known as promyelocytic leukemia zinc finger (PLZF)::RARA, is a rare variant RARA fusion rearrangement (<1% of cases) that phenotypically mimics acute promyelocytic leukemia (APL) but is resistant to alltrans retinoic acid (ATRA) and arsenic trioxide (ATO) due to the PLZF repressive domain...The patient received induction cladribine, idarubicin, cytarabine (CLIA) plus venetoclax...Supportive care included hydroxyurea, transfusions, and prophylaxis...Venetoclax-based regimens represent a promising approach in this rare entity. Long-term follow-up and potential consolidation with transplant are planned."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • Wilms Tumor • CD2 • CD34 • CD38 • KIT • NCAM1 • RARA • SMARCB1 • SMARCD3 • WT1 • ZBTB16

Efficacy and Toxicity of FLAG-IDA-Venetoclax Compared With Other Induction Regimens in Newly Diagnosed and Relapsed AML: A Real-World Single-Center Study (SOHO 2026) - "In this real-world study, comparison of AML induction strategies, response rates, MRD negativity, and key clinical outcomes were similar across 7+3, FLAG-IDA-venetoclax, and other regimens. FLAG-IDA-venetoclax showed potential comparable efficacy with numerically shorter durations of cytopenias. These findings add realworld context to venetoclax-based intensified induction strategies and may inform regimen selection in routine clinical practice."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

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

Comparing the Efficacy and Safety of Venetoclax Combined with Decitabine Versus Conventional Chemotherapy As Induction Therapy for Young Adults with Newly Diagnosed Acute Myeloid Leukemia - Interim Analysis of a Multicenter, Randomized, Phase 2b Trial (ASH 2023) - P2, P3 | "Here, we report the results of an interim analysis of a multicenter, randomized, phase 2b trial (NCT05177731) , which explored the efficacy and safety of VEN-DAC versus intensive chemotherapy (idarubicin and cytarabine) in ND AML patients. In newly diagnosed young AML patients, venetoclax in combination with decitabine as an induction regimen had comparable efficacy and a higher safety profile compared to IA-12 regimen. In particular, patients with adverse-risk AML showed higher and deeper remission rate in the venetoclax plus decitabine group as compared with the IA-12 group."

Clinical • P2b data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock

Olverembatinib-Based Treatment for Newly Diagnosed Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia: A Multi-Center Retrospective Study (SOHO 2026) - "Blinatumomab was applied for consolidation in 9 of 18 patients (50%). Nine of 18 (50%) patients have entered the maintenance therapy phase, of whom 6 received olverembatinib only, 2 received a combination of olverembatinib and chemotherapy, and 1 received a combination of dasatinib and chemotherapy due to financial issues... Olverembatinib-based regimen with lower-intensity chemotherapy showed promising outcomes with acceptable side effects as frontline therapy in patients with Ph+ ALL, warranting further trials to investigate better strategies. ALL: acute lymphoblastic leukemia, allo-HSCT: allogeneic hematopoietic stem cell transplantation, BCR::ABL1: breakpoint cluster region–Abelson murine leukemia viral oncogene homolog 1 fusion, CAR-T: chimeric antigen receptor T-cell, CMR: complete molecular remission, CR: complete response, IKZF1: Ikaros family zinc finger protein 1, PCR: polymerase chain reaction, Ph+: Philadelphia chromosome–positive, TKI: tyrosine kinase..."

Retrospective data • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • IKZF1

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

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

FIRST RESULTS OF THE APOLLO TRIAL: A RANDOMIZED PHASE III STUDY TO COMPARE ATO COMBINED WITH ATRA VERSUS STANDARD AIDA REGIMEN FOR PATIENTS WITH NEWLY DIAGNOSED, HIGH-RISK ACUTE PROMYELOCYTIC LEUKEMIA (EHA 2024) - "Background: Pioneered by the APL0406 trial (Lo-Coco et al., NEJM 2013), prior investigations have demonstrated the superiority of combining all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) over standard ATRA and chemotherapy (CHT) as front-line management of low/intermediate risk acute promyelocytic leukemia (APL)...Death in CR/CRi were observed in 0 and 3 pts in the ATRA-ATO and ATRA-CHT arm, respectively... First-line therapy with ATRA-ATO with two initial doses idarubicin results in superior EFS compared to conventional ATRA-CHT in patients with HR-APL. Further analysis of the APOLLO trial may support the implementation of this regimen as the new standard of care in patients with HR-APL"

Clinical • P3 data • Acute Promyelocytic Leukemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Septic Shock • Thrombosis

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 in combination with cytarabine with or without idarubicin or azacitidine in children, adolescents, and young adults with relapsed or refractory acute myeloid leukaemia (VENAML): a multicentre, phase 1 expansion study. (PubMed, Lancet Haematol) - P1, P3 | "Venetoclax with high-dose cytarabine is active with acceptable safety in paediatric patients with relapsed or refractory AML. These findings support ongoing research of venetoclax with high-dose cytarabine in this population, including the randomised paediatric phase 3 trial (NCT05183035)."

Journal • P1 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Neutropenia • Oncology • Pediatrics • Septic Shock

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

Venetoclax Plus Decitabine for Young Adults with Newly Diagnosed ELN Adverse-Risk Acute Myeloid Leukemia: Interim Analysis of a Prospective, Multicenter, Single-Arm, Phase 2 Trial (ASH 2021) - P2 | "Currently, the role of venetoclax in combination with azacitidine or decitabine in young adults with newly diagnosed ELN adverse-risk AML remains unclear...For pts with high FLT3-ITD allelic ratio, sorafenib was optional administered at a dose of 400mg orally twice daily...The endpoint is to show that venetoclax plus decitabine is superior to historical control (HC) of cytarabine combined with idarubicin (12 mg/m 2 ) in young adults with newly diagnosed ELN adverse-risk AML...Conclusions : Preliminary results indicate that venetoclax plus decitabine is an effective, lower-intensity regimen that is well tolerated for young adults with newly diagnosed ELN adverse-risk AML, producing high rates of CR, low rates of infections, and low rates of early death. Recruitment of young adults with newly diagnosed ELN adverse-risk AML pts for this trial is ongoing."

Clinical • P2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Pneumonia • Respiratory Diseases • Transplantation • FLT3

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