Publications by authors named "Nahla Hasabou"
BMT CTN 1506 ("MORPHO"; NCT02997202) was a randomized phase 3 study of gilteritinib compared to placebo as maintenance therapy after hematopoietic stem cell transplantation (HCT) for patients with FLT3-ITD-mutated acute myeloid leukemia (AML). A key secondary endpoint was to determine the impact on survival of pre- and/or post-HCT measurable residual disease (MRD), as determined using a highly sensitive assay for FLT3-ITD mutations. Generally, gilteritinib maintenance therapy was associated with improved relapse-free survival (RFS) for participants with detectable peri-HCT MRD, whereas no benefit was evident for those lacking detectable MRD.
View Article and Find Full Text PDFObjective: This interim analysis of a phase 1/2, open-label, single-arm study assessed the safety, efficacy, and pharmacokinetics of gilteritinib plus chemotherapy in adults with newly diagnosed FLT3 mutation-positive acute myeloid leukemia.
Methods: In sequential phase 1 and 2 studies, induction and consolidation therapy with gilteritinib 120 mg/day plus chemotherapy (induction: idarubicin/cytarabine once daily; consolidation: cytarabine twice daily) was followed by maintenance gilteritinib 120 mg/day monotherapy. Endpoints included maximum tolerated dose (MTD), recommended expansion dose (RED), and dose-limiting toxicity (phase 1), and complete remission (CR) rate following induction therapy (primary endpoint), overall survival (OS), safety, and pharmacokinetics (phase 2).
Article Synopsis
- The COMMODORE trial tested a new drug called gilteritinib against a treatment called salvage chemotherapy for patients with a type of blood cancer (AML) that has a specific gene mutation (FLT3).
- Results showed that patients taking gilteritinib lived longer (9.6 months) than those on chemotherapy (5.0 months) and also stayed healthier for longer without problems (2.8 months vs. 0.6 months).
- Gilteritinib led to fewer severe side effects, with common issues being low red blood cells and low platelet levels, making it a safer option for these patients.
Article Synopsis
- The BMT Clinical Trials Network conducted a phase 3 trial comparing gilteritinib to a placebo in patients with FLT3-ITD+ acute myeloid leukemia (AML) after hematopoietic cell transplantation (HCT).
- The study found no significant difference in relapse-free survival or health-related quality of life (HRQOL) between the two groups, despite more treatment-related side effects in those taking gilteritinib.
- Overall, gilteritinib maintenance did not lead to improved HRQOL, and results were consistent across different patient subgroups in terms of measurable residual disease.
Purpose: Allogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with AML harboring an internal tandem duplication mutation of () AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.
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- * Out of 80 participants, those treated with 120 mg gilteritinib daily showed a high composite complete response rate of 89% and a median overall survival of 46.1 months.
- * The findings support gilteritinib's integration into treatment regimens for AML, indicating it is safe and well-tolerated as both an initial treatment and maintenance therapy.
Outcomes in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy.
Transplant Cell Ther
April 2023
Article Synopsis
- Gilteritinib, a type of medicine for a serious blood cancer called FLT3-mutated acute myelogenous leukemia (AML), helped patients live longer in a study called the ADMIRAL trial.
- In the trial, some patients received gilteritinib, while others had different chemotherapy treatments, and those who did well could get gilteritinib again after a stem cell transplant.
- Overall, patients who took gilteritinib had better chances of going through a successful transplant and experienced lower relapse rates compared to those on chemotherapy.
Article Synopsis
- Gilteritinib, a FLT3 inhibitor, is effective for treating relapsed or refractory FLT3-mutated acute myeloid leukemia (AML), showing better response rates and survival than salvage chemotherapy.
- A study compared outcomes in patients with FLT3-mutated AML who had prior treatment with FLT3 tyrosine kinase inhibitors (TKIs) versus those who hadn't, revealing similar remission rates.
- Despite high remission rates for those previously treated with TKIs, gilteritinib still showed improved outcomes over salvage chemotherapy, although remission duration was shorter for patients who had prior FLT3 TKI exposure.
Article Synopsis
- The phase 3 ADMIRAL trial demonstrated that gilteritinib, an oral tyrosine kinase inhibitor, leads to significantly better overall survival in patients with relapsed/refractory FLT3-mutation-positive acute myeloid leukemia (AML) compared to salvage chemotherapy.
- After a median follow-up of 37.1 months, the median overall survival was 9.3 months for the gilteritinib group, vs. 5.6 months for the salvage chemotherapy group, with a 2-year survival estimate of 20.6% for gilteritinib compared to 14.2% for the control.
- Gilteritinib treatment showed a stable safety profile, with the most common adverse
Article Synopsis
- Gilteritinib, a FLT3 inhibitor, was recently approved in Japan as an effective treatment for FLT3-mutated relapsed/refractory acute myeloid leukemia (AML), showing better overall survival than salvage chemotherapy in the ADMIRAL trial.
- In the Japanese subgroup analysis, patients on gilteritinib had a median overall survival of 14.3 months compared to 9.6 months for those on salvage chemotherapy, with higher complete remission rates.
- Gilteritinib also resulted in fewer adverse events, although some patients experienced significant issues like febrile neutropenia and anemia.
Article Synopsis
- - Patients with relapsed or refractory acute myeloid leukemia (AML) and FLT3 mutations have limited response to traditional chemotherapy, but gilteritinib, a selective FLT3 inhibitor, shows promise.
- - In a phase 3 trial, 371 patients were randomly assigned to receive either gilteritinib or salvage chemotherapy, with key outcomes including overall survival and complete remission rates.
- - Results indicated that the gilteritinib group had a significantly longer median overall survival (9.3 months vs. 5.6 months) and higher remission rates (34.0% vs. 15.3%), along with fewer severe adverse events compared to the chemotherapy group.
Purpose: Enzalutamide significantly prolonged median progression-free survival vs bicalutamide in chemotherapy naïve men with metastatic castration resistant prostate cancer in the TERRAIN (Enzalutamide versus Bicalutamide in Castrate Men with Metastatic Prostate Cancer) trial. In this post hoc analysis we investigated the influence of age on the efficacy and safety of enzalutamide vs bicalutamide in this population.
Materials And Methods: Patients were randomized 1:1 to enzalutamide 160 mg per day or bicalutamide 50 mg per day.
Background: Enzalutamide is an oral androgen-receptor inhibitor that has been shown to improve survival in two placebo-controlled phase 3 trials, and is approved for patients with metastatic castration-resistant prostate cancer. The objective of the TERRAIN study was to compare the efficacy and safety of enzalutamide with bicalutamide in patients with metastatic castration-resistant prostate cancer.
Methods: TERRAIN was a double-blind, randomised phase 2 study, that recruited asymptomatic or minimally symptomatic men with prostate cancer progression on androgen-deprivation therapy (ADT) from academic, community, and private health-care provision sites across North America and Europe.
Background: The open-label, single-arm enzalutamide expanded access program (EAP) in the United States and Canada evaluated the safety of enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who had previously received docetaxel.
Methods: Patients (n = 507) received enzalutamide 160 mg/day until disease progression, intolerable adverse events (AEs), or commercial availability occurred. AEs and other safety variables were assessed on day 1, weeks 4 and 12, and every 12 weeks thereafter.
Pancreatic cancer screening has been hampered by the high rate of complications associated with interrogating the pancreas. The closest non-invasively accessible mucosa available for pancreatic cancer screening is the periampullary duodenal tissue. Our earlier report has shown the potential of using optical markers to interrogate this tissue for the presence of pancreatic cancer.
View Article and Find Full Text PDFBackground & Aims: We previously used a novel biomedical optics technology, 4-dimensional elastically scattered light fingerprinting, to show that in experimental colon carcinogenesis the predysplastic epithelial microvascular blood content is increased markedly. To assess the potential clinical translatability of this putative field effect marker, we characterized the early increase in blood supply (EIBS) in human beings in vivo.
Methods: We developed a novel, endoscopically compatible, polarization-gated, spectroscopic probe that was capable of measuring oxygenated and deoxygenated (Dhb) hemoglobin specifically in the mucosal microcirculation through polarization gating.
Purpose: We previously reported that analysis of histologically normal intestinal epithelium for spectral slope, a marker for aberrations in nanoscale tissue architecture, had outstanding accuracy in identifying field carcinogenesis in preclinical colorectal cancer models. In this study, we assessed the translatability of spectral slope analysis to human colorectal cancer screening.
Methods: Subjects (n = 127) undergoing colonoscopy had spectral slope determined from two endoscopically normal midtransverse colonic biopsies using four-dimensional elastic light-scattering fingerprinting and correlated with clinical findings.
Purpose: Pancreatic cancer remains one of the most deadly cancers and carries a dismal 5-year survival rate of <5%. Therefore, there is urgent need to develop a highly accurate and minimally invasive (e.g.
View Article and Find Full Text PDFBackground: Almost 20 million people in the US have chronic kidney disease (CKD). Cardiovascular disease and arterial wall abnormalities are common in this population. Because angiotensin II may have adverse effects on the arterial wall, we hypothesized that an angiotensin receptor blocker (ARB) would improve arterial compliance as compared with placebo in subjects with CKD.
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