- |||||||||| Ovastat (treosulfan) / Medac
Clinical, Journal: Treosulfan-Based Conditioning Regimen for Second Allograft in Patients with Myelofibrosis. (Pubmed Central) - Nov 1, 2020 The cumulative incidence of relapse at 5 years was 16%, resulting in a 5-year disease-free and overall survival of 45% and 47%, respectively. Treosulfan-based conditioning for second allograft in relapsed MF patients resulted in about 50% of the patients in long-term freedom from disease.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu Biosci, anastrozole / Generic mfg.
Review, Journal: Strategies to increase testosterone in men seeking fertility. (Pubmed Central) - Oct 22, 2020 Recently, a novel therapy, Natesto intranasal testosterone gel, has been shown to increase serum testosterone levels while maintaining semen parameters...Those with low 17-OHP may wish to initiate treatment with alternative therapies, whereas those with high 17-OHP may trial short-acting testosterone therapies. As the urologist's armamentarium continues to increase, better strategies to increase testosterone levels in men seeking fertility can be achieved.
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
Enrollment change, Trial termination: TrRaMM-TMI: Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT (clinicaltrials.gov) - Oct 19, 2020 P1, N=9, Terminated, As the urologist's armamentarium continues to increase, better strategies to increase testosterone levels in men seeking fertility can be achieved. N=18 --> 9 | Recruiting --> Terminated; low rate of enrolment
- |||||||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment closed, Trial completion date, Trial primary completion date: FOCUS: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (clinicaltrials.gov) - Sep 28, 2020 P3, N=102, Active, not recruiting, HER2-low status did not impact pCR rates or RFS of luminal and triple negative tumors treated with neoadjuvant chemotherapy. Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jul 2021 | Trial primary completion date: Apr 2020 --> May 2021
- |||||||||| Jivadco (trastuzumab duocarmazine) / Byondis, Medac
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: TULIP: SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Sep 23, 2020 P3, N=436, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jul 2021 | Trial primary completion date: Apr 2020 --> May 2021 Recruiting --> Active, not recruiting | Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Jul 2020 --> Jul 2021
- |||||||||| Ovastat (treosulfan) / Medac, fludarabine IV / Generic mfg., thiotepa / Generic mfg.
Journal: Haploidentical CD3 or α/β T-cell depleted HSCT in advanced stage sickle cell disease. (Pubmed Central) - Sep 21, 2020 In the T-haplo-HSCT and in the MSD, 20% and 22%, respectively, developed a mild or moderate chronic GvHD. These results demonstrate the feasibility, safety, and efficacy of T-haplo-HSCT also for adult advanced stage SCD patients.
- |||||||||| Xospata (gilteritinib) / Astellas, Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz, Nippon Shinyaku, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date, Trial primary completion date: A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov) - Sep 19, 2020 P3, N=1400, Recruiting, Trial primary completion date: Mar 2023 --> Jun 2023 Trial completion date: Feb 2025 --> Sep 2027 | Trial primary completion date: Feb 2025 --> Sep 2027
- |||||||||| Ovastat (treosulfan) / Medac, fludarabine IV / Generic mfg., cyclophosphamide intravenous / Generic mfg.
Journal, Combination therapy: Treosulfan in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation. (Pubmed Central) - Sep 18, 2020 On the basis of chimerism studies, the Treo-Flu megatherapy lacks full myeloablative potential, but the profound myelosuppression with donor cell-mediated alloreactivity can result in full donor chimerism in the majority of transplant recipients. The clinical studies of allogeneic hematopoietic stem cell transplantation show high heterogeneity, but the safety and feasibility of the Treo-Flu regimen are evident and support its place among reduced-intensity protocols.
- |||||||||| Ovastat (treosulfan) / Medac, Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA, Garamycin (gentamicin sulfate) / Generic mfg.
Clinical, Journal: Successful Allogeneic Stem Cell Transplantation in Nuclear Factor-Kappa B Essential Modulator Deficiency Syndrome After Treosulfan-Based Conditioning: A Case Report. (Pubmed Central) - Aug 6, 2020 Patients with NEMO deficiency syndrome require very complex, multidisciplinary care, and immunodeficiency correction can only be observed as one of the critical points in patient care. Developmental problems, enteropathy with the need for intravenous hyperalimentation, and specific interventions for other clinical manifestations of multifaceted syndrome are needed for proper care.
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