Uma Borate
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View article: A proposed path to explaining the unexplained anemia of aging
A proposed path to explaining the unexplained anemia of aging Open
Approximately 17% of people aged 65 years and older are anemic, and 10% of death certificates report anemia as a secondary cause of death in the United States. Nonetheless, anemia remains unexplained in 30%-50% of older adults. This unexpl…
View article: <i>IDH2</i> mutation is associated with favorable outcome among older adults with newly diagnosed acute myeloid leukemia treated with hypomethylating agent-based therapy
<i>IDH2</i> mutation is associated with favorable outcome among older adults with newly diagnosed acute myeloid leukemia treated with hypomethylating agent-based therapy Open
Mutations of isocitrate dehydrogenase (IDH) are recurrent in newly diagnosed (ND) acute myeloid leukemia (AML) and the prevalence increases with age. The prognostic impact of IDH mutations in AML remains controversial. IDH inhibitors gener…
View article: Results from paradigm - a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia
Results from paradigm - a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia Open
Introduction: For decades, standard upfront treatment for acute myeloid leukemia (AML) among fit patients (pts) has been intensive induction chemotherapy (IC), typically with cytarabine and anthracyclines. However, long-term outcomes remai…
View article: Trial in progress: A phase II study of ziftomenib monotherapy in unfit patients with newly diagnosed Acute Myeloid Leukemia with NPM1 mutation or KMT2A rearrangement
Trial in progress: A phase II study of ziftomenib monotherapy in unfit patients with newly diagnosed Acute Myeloid Leukemia with NPM1 mutation or KMT2A rearrangement Open
Background and Significance: Acute myeloid leukemia (AML) is an aggressive hematologic malignancy, with a median age of 69 years at diagnosis. As AML primarily affects older adults, treatment options can be limited by a patient's age and c…
View article: Venetoclax (VEN) and azacitidine (AZA) with gilteritinib (GILT) in patients with newly diagnosed (ND) FLT3mut+ Acute Myeloid Leukemia (AML) ineligible for intensive induction chemotherapy (chemo): Interim results from the phase 1/2 VICEROY study
Venetoclax (VEN) and azacitidine (AZA) with gilteritinib (GILT) in patients with newly diagnosed (ND) FLT3mut+ Acute Myeloid Leukemia (AML) ineligible for intensive induction chemotherapy (chemo): Interim results from the phase 1/2 VICEROY study Open
VEN/AZA is the standard frontline treatment for adults with ND AML (including FLT3mut+ disease) ineligible for intensive induction chemo due to older age or comorbidities. Complete remission (CR; 38.1%) and 12-month overall survival (OS; 5…
View article: RAS mutations negate the favorable impact of NPM1 in older patients with newly diagnosed Acute Myeloid Leukemia treated with ven/HMA
RAS mutations negate the favorable impact of NPM1 in older patients with newly diagnosed Acute Myeloid Leukemia treated with ven/HMA Open
Background: Activating RAS mutations play an important role in the pathogenesis of acute myeloid leukemia (AML) and occur in approximately 15-20% of patients with newly diagnosed (ND) AML. Although RAS mutations do not independently impact…
View article: The bromodomain and extra-terminal domain protein BRD4 promotes both self renewal and inflammation in TET2 mutated clonal hematopoiesis
The bromodomain and extra-terminal domain protein BRD4 promotes both self renewal and inflammation in TET2 mutated clonal hematopoiesis Open
Progression of clonal hematopoiesis (CH) to myeloid neoplasms (MN) is highly dependent upon inflammatory signaling. The epigenetic reader protein bromo- and extra-terminal domain 4 (BRD4) interacts with NF-kB and STAT transcription factors…
View article: Wide variability and inconsistency in reporting of results of Myelodysplastic Syndromes/neoplasms (MDS) clinical trials: An icMDS systematic review of published manuscripts
Wide variability and inconsistency in reporting of results of Myelodysplastic Syndromes/neoplasms (MDS) clinical trials: An icMDS systematic review of published manuscripts Open
Introduction: Standardized reporting of clinical trials results for MDS is essential to improve clinical interpretation and cross-study comparison. However, reporting of patient characteristics, response criteria, and endpoints in publicat…
View article: Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS)
Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS) Open
Introduction: Therapy related-MDS (tMDS), a known sequalae of genotoxic therapies, is a highly aggressive form of MDS accounting for 10–20% of newly diagnosed cases (Venugopal S et al, Semin Hematol 2024) with a dismal prognosis. Hypomethy…
View article: Preliminary data from the ongoing Phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory Acute Myeloid Leukemia
Preliminary data from the ongoing Phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory Acute Myeloid Leukemia Open
Introduction: Venetoclax and azacitidine (VEN/AZA) is a standard backbone regimen for older/unfit patients (pts) with newly diagnosed AML and can also be administered in the relapsed or refractory (R/R) setting. Menin inhibitors are an imp…
View article: Safety of gemtuzumab ozogamicin with cytarabine, daunorubicin, and midostaurin induction in FLT3-mutated AML
Safety of gemtuzumab ozogamicin with cytarabine, daunorubicin, and midostaurin induction in FLT3-mutated AML Open
This phase 1 study investigated the addition of gemtuzumab ozogamicin (GO) to intensive chemotherapy with cytarabine, daunorubicin, and midostaurin in 21 patients with newly diagnosed (ND) FMS-like tyrosine kinase 3 (FLT3)-mutated acute my…
View article: Real-world experience of venetoclax target dosing with concomitant posaconazole in adult patients with acute myeloid leukemia
Real-world experience of venetoclax target dosing with concomitant posaconazole in adult patients with acute myeloid leukemia Open
Venetoclax creates ongoing challenges when combined with posaconazole due to a known drug-drug interaction. Herein, we investigated the safety between venetoclax 100mg and 70mg when administered with posaconazole in acute myeloid leukemia …
View article: Supplementary Table S5 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S5 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Treatment Completion and Reason Off Treatment
View article: Supplementary Figure S4 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Figure S4 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
p-H2AX as a pharmacodynamic biomarker for TP-0903. Spectral flow cytometry was performed to assess p-H2AX using peripheral blood collected at day 1 (i.e., baseline) and day 10, and change from screening was calculated for patients that ach…
View article: Supplementary Table S2 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S2 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Dose Escalation Table
View article: Supplementary Table S6 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S6 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
TP-0903 and metabolite pharmacokinetic parameters on days 1 and 10 of course 1
View article: Supplementary Figure S2 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Figure S2 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Sequencing data. Serial sequencing versus response.
View article: Supplementary Table S1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Inclusion and Exclusion Criteria
View article: Supplementary Table S7 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S7 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Research Resource Identifiers (RRID)
View article: Supplementary Figure S3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Figure S3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Pharmacokinetic exposure versus toxicity/response. (A) Steady-state plasma levels of TP-0903 parent drug in non-responders and responders (CR, CRh, CRi, MLFS). Percent decrease in (B) absolute neutrophil count (ANC) or (C) platelets in pat…
View article: Supplementary Table S3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Representativeness of Study Participants
View article: Supplementary Table S4 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S4 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
All-Cause Adverse Events
View article: Supplementary Methods from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Methods from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Supplementary Methods
View article: Supplementary Figure S1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Figure S1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Consort diagram
View article: Supplementary Table S7 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S7 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Research Resource Identifiers (RRID)
View article: Supplementary Figure S2 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Figure S2 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Sequencing data. Serial sequencing versus response.
View article: Figure 3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Figure 3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
TP53 VAF. A,TP53 VAF by best response. TP53 VAF over time in patients that achieved CR/CRh/CRi/MLFS (B) without relapse on study or (C) with relapse while on study. Patients who received 37 mg TP-0903 are represented by closed symbols, whe…
View article: Supplementary Figure S3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Figure S3 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Pharmacokinetic exposure versus toxicity/response. (A) Steady-state plasma levels of TP-0903 parent drug in non-responders and responders (CR, CRh, CRi, MLFS). Percent decrease in (B) absolute neutrophil count (ANC) or (C) platelets in pat…
View article: Figure 1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Figure 1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
OS and duration of response. Patients were treated according to the (A) study schema. B, OS and (C) duration of response among patients who achieved CR + CRh + CRi. The median OS for all patients (n = 27) was 7.6 months (95% CI, 3.3–13.4) …
View article: Supplementary Table S1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years
Supplementary Table S1 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant <i>TP53</i> and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years Open
Inclusion and Exclusion Criteria