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March 26, 2026
VAG-3+7-G: VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML
(clinicaltrials.gov)
- P3 | N=300 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Initiation date: Jan 2026 ➔ Apr 2026
Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2 • FLT3
April 29, 2023
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
February 26, 2025
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
November 04, 2025
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
August 19, 2025
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
March 21, 2026
Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML
(clinicaltrials.gov)
- P3 | N=204 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University
New P3 trial • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology
April 07, 2025
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
May 16, 2025
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
March 05, 2026
NCI-2019-08626: BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia
(clinicaltrials.gov)
- P2 | N=49 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2026 ➔ Jan 2027
Trial completion date • Tumor mutational burden • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
March 18, 2026
The Relationship between OPN, NLR and Chemotherapy Efficacy in Patients with Acute Myeloid Leukemia
(PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi)
- "The combination of Ara-C and IDA in AML patients has a risk of ineffective induction chemotherapy, which may be related to serum OPN and NLR values. High expression of serum OPN and elevated NLR value may increase the risk of ineffective induction chemotherapy. The combination of serum OPN and NLR can assist in improving the predictive value of Ara-C combined with IDA in AML patients."
Journal • Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • B2M • SPP1
March 18, 2026
Cuproptosis induction in TP53-mutated acute myeloid leukemia
(AACR 2026)
- "In contrast, cytarabine, idarubicin, and venetoclax activity was substantially diminished in TP53-deficient cells, consistent with the known resistance of TP53-mutated AML to these standard therapies. Notably, combining low-dose elesclomol with the hypomethylating agent decitabine, which has established clinical efficacy in TP53-mutated AML, produced a synergistic increase in apoptosis in TP53-deficient AML cells.Together, these findings demonstrate that copper ionophores can bypass TP53-associated resistance to AML cell death by activating cuproptosis rather than relying on p53-dependent apoptotic pathways. The robust activity of copper ionophores across diverse TP53-deficient AML models, coupled with the enhanced efficacy observed in combination with decitabine, underscores cuproptosis induction as a promising therapeutic approach for TP53-deficient AML."
Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • TP53
March 18, 2026
Optical spectral fingerprinting for anthracycline detection in synthetic clinical biofluids
(AACR 2026)
- "To create chemical library diversity, multi-species SWCNT were dispersed with 12 unique ssDNAs and challenged with four anthracyclines: daunorubicin, doxorubicin, epirubicin, and idarubicin, at concentrations ranging from 0.1-100 μM. Future work will use these ssDNA-SWCNT species combinations to develop a noninvasive therapeutic drug monitoring tool to monitor accumulation at the tumor and in the heart during chemotherapy. We anticipate this work leading to a tool to improve tolerance for anthracycline chemotherapy by establishing personalized pharmacological treatment windows."
Clinical • Oncology
March 06, 2025
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
January 10, 2026
QUIZARTINIB AND IDARUBICIN ASSOCIATED MYOPERICARDITIS IN A PATIENT WITH AML
(ACC 2026)
- "For cytoreduction, idarubicin and cytarabine were initiated 7 days prior to quizartinib...Decision-Making: Quizartinib was stopped, and colchicine and guideline-directed medical therapy for heart failure were initiated... This case highlights synergistic cardiotoxicity mediated by idarubicin and quizartinib. Anthracycline-induced cardiomyocyte injury resulting in exposed cardiac antigens, followed by FLT3-mediated impaired immune tolerance, may have led to myocarditis in this patient."
Clinical • Acute Myelogenous Leukemia • Cardiovascular • CNS Disorders • Congestive Heart Failure • Depression • Heart Failure • Hypotension • FLT3
March 16, 2026
A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis.
(PubMed, Ther Adv Hematol)
- P1/2 | "All patients enrolled in phase II received induction and consolidation therapy with gilteritinib 120 mg/day plus chemotherapy (induction: ⩽2 cycles, idarubicin/cytarabine once-daily; consolidation: ⩽4 cycles, cytarabine twice-daily) followed by maintenance with gilteritinib 120 mg/day monotherapy (⩽26 cycles). Induction and consolidation with gilteritinib plus chemotherapy, and maintenance with gilteritinib monotherapy were well tolerated in ND patients in Asia with FLT3 mut+ AML and had favorable efficacy compared with historical data. This trial was registered with the ClinicalTrials.gov identifier NCT02310321."
Journal • P1/2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • FLT3
February 25, 2026
Leukemia Cutis: Clinicopathologic and Genomic Correlation in Skin–Marrow Pairs
(USCAP 2026)
- "Most c-AML cases (80%) received 7+3 chemotherapy while CMN treatments varied, including inqovi, tyrosine kinase inhibitors, hypomethylating agents alone or with venetoclax...Results Table: Table 1: Clinicopathologic and Genomic Correlation among myeloid neoplasms (acute and chronic) involving skin and bone marrow BM- bone marrow, CML- chronic myeloid leukemia, MPN- myeloproliferative neoplasm, CMML- chronic myelomonocytic leukemia, a CML- atypical chronic myeloid leukemia, BCR::ABL1 negative, MDS/MPN- myelodysplastic/myeloproliferative neoplasm, MDS- myelodysplastic syndrome, WBC- white blood cell count, Hb- hemoglobin, PLT- platelet count, MR-myelodysplasia related, NOS- not otherwise specified, 7 + 3 therapy- cytarabine + anthracycline, HMA- hypomethlating agents, Ven-venetoclax, FLAG-Ida-Ven- fludarabine + cytarabine+ granulocyte colony-stimulating factor (G-CSF)+ idarubicin+ venetoclax, TKI-tyrosine kinase inhibitor, BMT-bone marrow transplant, CR- clinical..."
Clinical • Acute Myelogenous Leukemia • Atypical Chronic Myeloid Leukemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • ABL1 • ASXL1 • DNMT3A • ETV6 • FLT3 • JAK2 • KMT2A • KRAS • NPM1 • NRAS • PTPN11 • RUNX1 • TET2 • TP53 • WT1
March 14, 2026
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
March 14, 2026
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
February 07, 2026
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
February 07, 2026
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
February 07, 2026
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
February 07, 2026
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
February 07, 2026
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
February 07, 2026
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
March 14, 2026
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
(clinicaltrials.gov)
- P2 | N=22 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2029 ➔ May 2029 | Trial primary completion date: May 2027 ➔ Jan 2026
Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • FLT3
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