- |||||||||| Jivadco (trastuzumab duocarmazine) / Byondis, Medac
Trial primary completion date, Combination therapy, Metastases: Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors (clinicaltrials.gov) - Aug 3, 2022 P1, N=120, Active, not recruiting, Active, not recruiting --> Recruiting | N=48 --> 196 Trial primary completion date: Jul 2022 --> Dec 2022
- |||||||||| Defitelio (defibrotide) / IRCCS San Raffaele Hospital, Jazz, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal: Defibrotide Prophylaxis of Sinusoidal Obstruction Syndrome in Adults Treated With Inotuzumab Ozogamicin Prior to Hematopoietic Stem Cell Transplantation. (Pubmed Central) - Jul 6, 2022 GvHD prophylaxis included post-transplant cyclophosphamide, rapamycin and mycophenolate...All three patients were characterized by a common pattern of very high risk factors by prior HSCT, they all received a myeloablative conditioning with Treosulfan-Thiotepa and a MMRD transplant. Defibrotide prophylaxis apparently failed to protect against the development of SOS in those patients treated with a double alkylator-based conditioning regimen, while a possible efficacy for the other high-risk patients is debatable.
- |||||||||| Jivadco (trastuzumab duocarmazine) / Byondis, Medac
Enrollment closed, Trial primary completion date, Metastases: SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma (clinicaltrials.gov) - Jun 22, 2022 P2, N=60, Active, not recruiting, Furthermore, it avoids the sequelae associated with corticosteroids; is a good option to consider in patients with prognostic features associated with better outcomes, such as adults; female patients. Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2022 --> Dec 2022
- |||||||||| oNKord (GCT NK cells) / Glycostem, Medac, Korea Kolmar
Enrollment open, Trial initiation date: Registry of Patients Having Received oNKord® (clinicaltrials.gov) - Jun 21, 2022 P=N/A, N=50, Recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2022 --> Dec 2022 Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jun 2022
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
New P4 trial: Natesto Spermatogenesis Reboot (clinicaltrials.gov) - May 19, 2022 P4, N=30, Not yet recruiting,
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
Biomarker, Journal, Heterogeneity: Interpatient Heterogeneity in Drug Response and Protein Biomarker Expression of Recurrent Ovarian Cancer. (Pubmed Central) - May 15, 2022 The second-line combination therapy of carboplatin with gemcitabine was significantly superior to the combination of carboplatin with PEGylated liposomal doxorubicin (p < 0.0001) or paclitaxel (p = 0.0007)...Treosulfan showed the highest efficacy of all nonplatinum agents, with significant advantage over vinorelbine (p < 0.0001) and topotecan (p < 0.0001), the next best agents...Biological heterogeneity observed in recurrent ovarian cancers might explain the strong differences in the clinical drug response of these patients. Preclinical drug testing and biomarker profiling in the ovarian-cancer spheroid model might help in optimizing treatment management for individual patients.
- |||||||||| Spectrila (asparaginase Escherichia coli) / Medac
Trial completion date, Trial primary completion date: PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia (clinicaltrials.gov) - May 10, 2022 P2, N=40, Active, not recruiting, Despite several limitations due to uneven distribution concerning age and remission status, we demonstrate that Flu/Treo and FLAMSA-RIC provide similar outcomes and are feasible in older and intensively pre-treated patients. Trial completion date: Apr 2023 --> May 2026 | Trial primary completion date: Mar 2022 --> May 2025
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
PK/PD data, Journal: Evaluation of the Drug-Drug Interaction Potential of Treosulfan using a Physiologically-Based Pharmacokinetic Modelling Approach. (Pubmed Central) - Apr 27, 2022 Medicinal products with a narrow therapeutic index (e. g. digoxin) that are substrates for CYP3A4, CYP2C19, or P-gp should not be given during treatment with treosulfan. However, considering the comprehensive treosulfan-based conditioning treatment schedule and the respective PK properties of the concomitantly used drugs (e.g., half-life), the potential for interaction on all evaluated mechanisms would be low (AUC < 1.25), if concomitantly administered drugs are dosed either 2 h before or 8 h after the 2 h i.v. infusion of treosulfan.
- |||||||||| Ovastat (treosulfan) / Medac, Medexus, Campath (alemtuzumab) / Sanofi
Journal: T-replete HLA-matched Grafts vs T-depleted HLA-mismatched Grafts in Inborn Errors of Immunity. (Pubmed Central) - Apr 27, 2022 All patients received treosulfan-based conditioning except patients with DNA repair disorders...Higher incidence of viraemia (p<0.001) and delayed CD3 reconstitution (p=0.003) were observed after T-depleted graft HCT. These data indicate that mismatched donor transplant after TCR αβ and CD19 depletion represents an excellent alternative for younger children with IEI in need of an allograft.
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
Reduced intensity conditioning with fludarabine, treosulfan and anti-thymocyte globulin (FluTreoATG)—A single-centre experience () - Apr 25, 2022 - Abstract #BSH2022BSH_257; We elected to replace our existing conditioning regimen of Flu, reduced dose busulfan (8 mg/kg) and anti-thymocyte globulin (ATG) which we used for patients aged 60 years and over with the FluTreoATG protocol...Graft-versus-host disease (GvHD) prophylaxis consisted of IV ciclosporin (1.5 mg/kg bd) from day −1 and MMF (15 mg/kg tds) from day 0...Forty-four per cent of those patients with post-transplant EBV reactivation needed Rituximab...In conclusion, this single-centre analysis demonstrates that alloHCT with FluTreoATG conditioning regimen is well-tolerated with comparable efficacy to the published results of other RIC allo-HCT. In view of the major limitations of our study (its retrospective nature and a small cohort with limited follow-up), prospective multicentre studies in comparison with other RIC are warranted.
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
Journal: Hematopoietic stem cell transplantation for Wiskott-Aldrich syndrome: an EBMT inborn errors working party analysis. (Pubmed Central) - Apr 5, 2022 Patients receiving treosulfan-based conditioning had a higher incidence of graft failure, mixed donor chimerism and more frequently received secondary procedures (2nd HSCT, unconditioned stem cell boost, donor lymphocyte infusion, or splenectomy). In summary, HSCT for WAS with conditioning regimens currently recommended by IEWP results in excellent survival and low rates of GVHD, regardless of donor or stem cell source, but age ≥5 years remains a risk factor for overall survival.
- |||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, trastuzumab duocarmazine (SYD985) / Byondis
Journal: Impact of Human Epidermal Growth Factor Receptor 2 (HER2) Low Status in Response to Neoadjuvant Chemotherapy in Early Breast Cancer. (Pubmed Central) - Apr 5, 2022 There were statistically significant differences regarding estrogen (p = 0.00) and progesterone (p = 0.02) receptors...The prevalence of hormonal receptors in HER2-low tumors was consistent with previous data in the literature. Although retrospective, the data suggest that HER2-low tumors should be regarded as a distinct biological subtype and more research is warranted.
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