Sep 9th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

Sep 30th, 2022 - The primary endpoints are to test the pulse sequences under development to image lung ventilation and perfusion, cardiac perfusion and brain uptake of xenon The study will seek to test the given pulse sequence under investigation in a group of up to 40 volunteers. To be eligible, each subject will have no contraindications to MRI scanning and will have signed the necessary volunteer consent for...

Sep 30th, 2022 - PRIMARY OBJECTIVE: I. To determine the efficacy, based on progression-free survival (PFS), of fluorouracil, oxaliplatin, and leucovorin calcium (modified [m]FOLFOX6)/bevacizumab plus atezolizumab (combination) as compared to single agent atezolizumab. SECONDARY OBJECTIVES: I. To compare the overall survival. II. To compare the objective response rates (ORR) per Response Evaluation Criteria in S...

Sep 30th, 2022 - The lumbar square block is an interfascial block of the posterior wall of the abdomen, initially described for the management of postoperative pain in abdominal surgery due to its suggested effect on the T7-11 roots. The analgesic efficacy of type 1 lumbar square block (QL1) in hip surgery was subsequently published. Regarding chronic pain, QL2 has been successfully performed in posttherniorrha...

Sep 30th, 2022 - This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2 positive breast cancer. The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits. Participants wil...

Sep 30th, 2022 - Part 1 of the study is an exploratory comparison of the relative oral bioavailability of the two dispersible tablets versus risdiplam powder for oral solution as the reference. The effect of food on the bioavailability of the two dispersible tablets will be assessed by comparing fed and fasted states in a five-way crossover manner. It will also be assessed whether antacids (omeprazole) have an ...

Sep 30th, 2022 - This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous ...

Sep 30th, 2022 - Study Description: This will be a phase 2, open label, single arm study of denosumab treatment to prevent fibrous dysplasia (FD) lesion progression in children. Objectives: Primary Objective: Evaluate the effect of denosumab on FD lesion progression in children. Secondary Objectives: Evaluate the effects of denosumab on FD lesion activity. Evaluate the effect of denosumab on strength and mobili...

Sep 30th, 2022 - Background: Despite improvements in therapy, acute lymphoblastic leukemia (ALL) contributes to significant morbidity and mortality for children and young adults with cancer. CD19-CAR and CD22-CAR therapy have proven highly effective in inducing remission in patients with relapsed/refractory disease. Immune escape has been observed by several groups following CD19-CAR and CD22- CAR therapy for B...

Sep 30th, 2022 - PRIMARY OBJECTIVE: I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib S-malate (cabozantinib) with atezolizumab versus cabozantinib alone. SECONDARY OBJECTIVES: I. To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone. II. To compare Resp...

Sep 30th, 2022 - The study will have three phases: screening, treatment and healing confirmation. The screening phase is to determine eligibility of subjects and chronicity of the diabetic foot ulcer and will include off-loading. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects will be treated weekly with the Omeza combination therapy and standard of care to conti...

Sep 30th, 2022 - Background: Post-transplantation cyclophosphamide (PTCy) reduces rates of severe acute and chronic graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) and safely facilitates human leukocyte antigen (HLA)-haploidentical HCT When clinically translated, the dose (50 mg/kg) and timing (days +3 and +4) of PTCy used were partly extrapolated from murine major his...

Sep 30th, 2022 - Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe...

Sep 30th, 2022 - Primary Objectives: AML MRD cohort: To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD MDS post-HMA cohort: To determine the response rate (defined as CR + marrow CR [mCR] + partial remission [PR] + hematologic improvement [HI]) after 4 cycles of vibecotamab in patients with MDS after HMA failure Secondary Objectives: To assess other efficacy endpoi...

Sep 30th, 2022 - This open label, randomized study will evaluate safety and tolerability of sargramostim when combined with an ipilimumab-containing regimen received as part of standard of care therapy. The study will evaluate 2 sargramostim administration schedules. Patients will be randomized 1:1 to the sargramostim administration schedules and stratified based on planned dose of ipilimumab (1 mg/kg, 3 mg/kg)...

Sep 30th, 2022 - As per brief summary

Sep 30th, 2022 - This is a phase I/II clinical trial. The objective of the study is patients with leptomeningeal metastases from solid tumors. Pemetrexed (Alimta, Eli Lilly and Company) is administrated by intrathecal injection, plus dexamethasone 5 mg, twice per week for 2 weeks, followed by once per week for 4 weeks. In phase I study, the initial dose of intrathecal pemetrexed is 15 mg, escalated to 20 mg, an...

Sep 30th, 2022 - Study Description: This study will evaluate the clinical and laboratory effects of immunotherapies in patients who recovered from acute mildmoderate COVID-19 infection but still have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are n...

Sep 30th, 2022 - Background: High unmet medical need for relapsed/refractory non-Hodgkin lymphoma (NHL) after exhausting chemotherapy and/or chemo-immunotherapy regimens Targeted therapies aimed at disrupting cell death pathway in hematologic malignancies are emerging and showing significant activity in both the relapsed and first-line settings VIP152 is a selective inhibitor of PTEFb/CDK9 and is expected to sh...

Sep 30th, 2022 - The Phase II stage will be a multicenter, randomized, observer-blinded, active-controlled trial. About 300 eligible participants will be randomized equally (1:1:1) into 20 μg ReCOV group, 40 μg ReCOV group, and the control vaccine [COVID-19 Vaccine (Vero Cell), Inactivated] group, respectively, stratified by age (18 to < 50 years, ≥ 50 to ≤ 65 years) and the duration since the last dose of prim...