ANZCTR search results

This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

This is an Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Naltrexone HCL to DLP-160 (Naltrexone implant) to Intramuscular Vivitrol®

Quetiapine is medication used to treat schizophrenia and bipolar disorder. Increasingly, low doses of quetiapine are prescribed "off-label" for insomnia. Quetiapine increases sleep duration with fewer interruptions, and people report feeling more rested. This accounts for why it is popular to prescribe for insomnia. Insomnia and obstructive sleep apnea (OSA) share many symptoms and differential diagnosis can be difficult. While quetiapine may improve sleep and breathing in certain people (i.e in light sleepers) an initial study indicated that quetiapine caused breathing disturbances in healthy individuals. Effects in OSA are unknown. In this placebo-controlled double blind study, participants with mild-moderate OSA will spend 2 nights in the sleep lab, one with quetiapine at a dose commonly prescribed for insomnia and one with placebo. The investigators will assess participants sleep by standard clinical sleep study, and morning alertness using questionnaires, reaction tests, and a driving simulator test.

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.

The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (\~144 weeks) for participants.

This is an optional open-label extension to participants that have completed the clinical trial CNMAu8.205.