PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03965546: ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer
Official title: Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer
Conditions: Hepatocellular Carcinoma
Liver Cancer
Liver Neoplasms
Metastatic Liver Cancer
Summary: The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer
Interventions:
description: 1. Sorafenib starting dose of 400mg b.i.d. a.c.<br/>2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion
name: Sorafenib combined with ET140202-T cell
type: Combination Product
description: 1. Transarterial embolization(TAE) treatment<br/>2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)
name: TAE combined with ET140202-T cell
type: Combination Product
description: Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
name: ET140202-T cell
type: Biological
Study arms:
design_group_description: Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion
design_group_title: ET140202-T cell combine with Sorafenib
design_group_type: Experimental
design_group_description: TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion
design_group_title: ET140202-T cell combine with TAE
design_group_type: Experimental
design_group_description: autologous ET140202-T cell administered by intravenous (IV) infusion
design_group_title: solo ET140202-T cell
design_group_type: Experimental
Sponsor: First Affiliated Hospital of Xi'an Jiaotong University
Collaborators: Eureka Therapeutics, Inc.
Drug name mappings:
name: ET1402L1-CART
lang: EN
name: 甲苯磺酸索拉非尼
lang: CN
name: Sorafenib Tosylate
lang: EN
name: ソラフェニブトシル酸塩
lang: JP
Clinical trial NCT04982354: Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
Official title: A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft
Conditions: Acute Myeloid Leukemia
Summary: This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.
Interventions:
description: For this trial, patients will be treated with CPX-351 100 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) for 3 doses on days 1, 3 and 5 of one and on days 1 + 3 of a second cycle of induction therapy, depending on response obtained following the first induction. Thereafter, up to 2 cycles of consolidation therapy of 2 doses on days 1 and 3 of daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 will be administered to the patients.
name: CPX-351
type: Drug
description: The FLT3 directed inhibitor, midostaurin, will be given at a dose of 50mg twice daily, starting on day 8 through day 21 of each cycle of CPX-351 until admission for allogeneic stem cell transplant.
name: Midostaurin
other_name: Rydapt
type: Drug
description: 0.8 mg/kg/dose every six hours x 12 doses administered intravenously
name: Busulfan
other_name: Myleran
type: Drug
description: 70 mg/m2/day x 2 doses administered intravenously
name: Melphalan
other_name: Alkeran
type: Drug
description: 25 mg/m2/day x 5 doses administered intravenously
name: Fludarabine
other_name: Fludara
type: Drug
description: Allogeneic stem cell transplant infused intravenously
name: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
type: Biological
Study arms:
design_group_description: Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
design_group_title: Investigational Treatment
design_group_type: Experimental
Sponsor: Baptist Health South Florida, Inc.
Collaborators: Jazz Pharmaceuticals Plc
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 米哚妥林
lang: CN
name: Midostaurin
lang: EN
name: ミドスタウリン
lang: JP
name: 美法仑
lang: CN
name: Melphalan
lang: EN
name: メルファラン
lang: JP
name: 柔红霉素/阿糖胞苷脂质体
lang: CN
name: Cytarabine/Daunorubicin Liposomal
lang: EN
name: ダウノルビシン塩酸塩（JAN/シタラビン（JAN）
lang: JP
Clinical trial NCT03721510: A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
Official title: A Phase 1/2a Open Label Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
Conditions: HIV/AIDS
Summary: This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
Interventions:
description: PGT121 + VRC07-523LS, dose 30 mg/kg each, given intravenously
name: PGT121 + VRC07-523LS
type: Biological
description: PGT121 + VRC07-523LS + PGDM1400, dose 20 mg/kg each, given intravenously
name: PGT121 + VRC07-523LS + PGDM1400
type: Biological
Study arms:
design_group_description: HIV-uninfected volunteers receiving one IV infusion
design_group_title: Group 1A
design_group_type: Active Comparator
design_group_description: HIV-uninfected volunteers receiving one IV infusion
design_group_title: Group 1B
design_group_type: Active Comparator
design_group_description: HIV-infected volunteers on ART receiving three or six IV infusions
design_group_title: Group 2
design_group_type: Active Comparator
Sponsor: International AIDS Vaccine Initiative, Inc.
Collaborators: Orlando Immunology Center P A
Beth Israel Deaconess Medical Center, Inc.
National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: PGT-121
lang: EN
name: VRC-07-523
lang: EN
Clinical trial NCT04194086: Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
Official title: Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
Conditions: Leukemia, Acute
Summary: This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.
Interventions:
description: posaconazole oral suspensions（5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.
name: posaconazole oral suspensions
type: Drug
Study arms:
design_group_title: posaconazole as antifungal prophylaxis
design_group_type: Experimental
Sponsor: Zhujiang Hospital of Southern Medical University
Collaborators: Guangdong General Hospital
Drug name mappings:
name: 泊沙康唑
lang: CN
name: Posaconazole
lang: EN
name: ポサコナゾール
lang: JP
Clinical trial NCT00699842: A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients
Official title: A Phase I/II Optimal Dose Study of Lenalidomide in the Non-5q- LOW and INT-1 Risk MDS Patients
Conditions: Myelodysplastic Syndrome
MDS
Low to Intermediate-1 MDS
Non-deletion 5q
Summary: Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality called "deletion 5q" in Low and Intermediate-1 (INT-1) patients (staging system according to International Prognostic Scoring System (IPSS)). The purpose of this Phase I/II study is to determine the optimal dose of Revlimid® (Lenalidomide) in MDS Low and MDS INT-1 patients without deletion 5q by slowly increasing the dose while monitoring blood counts for safety evaluation as well as observe other adverse events. Efficacy will also be observed for the phase II portion of the study.
Interventions:
description: Dose Level Lenalidomide Schedule<br/>1. 15mg/day for d1-21 out of 28 days<br/>2. 20mg/day for d1-21 out of 28 days<br/>3. 25mg/day for d1-21 out of 28 days
name: Lenalidomide
other_name: Revlimid
type: Drug
Study arms:
design_group_description: Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
design_group_title: Lenalidomide
design_group_type: Experimental
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators: Celgene Corp.
Drug name mappings:
name: 来那度胺
lang: CN
name: Lenalidomide
lang: EN
name: レナリドミド水和物
lang: JP
Clinical trial NCT06432166: 2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients
Official title: 2-Hydroxybenzylamine (2-HOBA) Phase 1b/2a Proof-of Concept, Dose-Finding, Biomarker Study in Early Alzheimer's Patients
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Summary: Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- & MDA), pTau-181, YKL-40, and NF-L.
Interventions:
description: 2-hydroxybenzylamine acetate (2-HOBA) is taken three times per day for 16 weeks
name: 2-hydroxybenzylamine acetate
other_name: 2-HOBA
type: Drug
description: Placebo taken three times per day for 16 weeks.
name: Placebo
type: Other
Study arms:
design_group_description: Placebo treatment TID for 16 weeks.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: 250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
design_group_title: 250 mg 2-HOBA acetate
design_group_type: Active Comparator
design_group_description: 500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
design_group_title: 500 mg 2-HOBA acetate
design_group_type: Active Comparator
design_group_description: 750 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
design_group_title: 750 mg 2-HOBA acetate
design_group_type: Active Comparator
Sponsor: MTI Biotech, Inc.
Collaborators: Vanderbilt University Medical Center
Drug name mappings:
name: 2-羟基苄胺
lang: CN
name: 2-Hydroxybenzylamine
lang: EN
Clinical trial NCT00006968: Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
Official title: Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
Conditions: Kidney Cancer
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer.
Interventions:
name: filgrastim
type: Biological
name: cyclosporine
type: Drug
name: pentostatin
type: Drug
name: allogeneic bone marrow transplantation
type: Procedure
name: peripheral blood stem cell transplantation
type: Procedure
Study arms:
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
name: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
name: 喷司他丁
lang: CN
name: Pentostatin
lang: EN
name: ペントスタチン
lang: JP
Clinical trial NCT00964548: Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage
Official title: Dantrolene in the Treatment of Cerebral Vasospasm After Subarachnoid Hemorrhage - a Phase 1 Study
Conditions: Cerebral Vasospasm After Subarachnoid Hemorrhage
Summary: Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.
Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.
Interventions:
description: 1.25 mg/kg IV once over 60 min
name: Dantrolene
type: Drug
description: 2.5 mg/kg IV once over 60 min
name: Dantrolene
type: Drug
Study arms:
design_group_title: Dantrolene (low dose)
design_group_type: Experimental
design_group_title: Dantrolene (high dose)
design_group_type: Experimental
Sponsor: University of Massachusetts
Collaborators: The General Hospital Corp.
Drug name mappings:
name: 丹曲林钠
lang: CN
name: Dantrolene Sodium
lang: EN
name: ダントロレンナトリウム水和物
lang: JP
Clinical trial NCT04923542: Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases
Official title: Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases
Conditions: Brain Metastases
HR+ Metastatic Breast Cancer
Summary: This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
Interventions:
description: Patients will receive single session SRS to intact brain metastases and post-operative cavities. For intact brain metastases, this will be 15 Gy to lesions between 31-40 mm, 18 Gy to 21- 30 mm, and 24 Gy to lesions measuring ≤ 20 mm.
name: Stereotactic Radiosurgery (SRS)
type: Radiation
description: Abemaciclib is an orally administered selective small-molecule inhibitor of CDK4 and CDK6 that is 14 times more potent against CDK4 than CDK6 in enzymatic assays that is approved for the treatment of advanced or metastatic breast cancers. Abemaciclib will be administered at a dose of 150 mg twice daily.
name: Abemaciclib
other_name: Ramiven
Verzenio
type: Drug
description: Abemaciclib will be administered with standard of care endocrine therapy. Endocrine therapy can consist of fulvestrant or an aromatase inhibitor. Dosing of concurrent endocrine therapy with abemaciclib should follow standard dosing and safety guidelines.
name: Endocrine therapy
other_name: hormone therapy
type: Drug
Study arms:
design_group_description: Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation to sites of brain metastases or post-operative cavities with continued abemaciclib. In the phase I portion, safety will be monitored initially by a 3+3 design. If unexpected neurologic toxicities are noted, the dose of radiation therapy will be modified.
design_group_title: Phase 1: Radiation Therapy and Abemaciclib
design_group_type: Experimental
design_group_description: Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation at the phase 1 dose to sites of brain metastases or post-operative cavities with continued abemaciclib.
design_group_title: Phase 2: Radiation Therapy and Abemaciclib
design_group_type: Experimental
Sponsor: H. Lee Moffitt Cancer Center & Research Institute, Inc.
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 阿贝西利
lang: CN
name: Abemaciclib
lang: EN
name: アベマシクリブ
lang: JP
Clinical trial NCT01165112: Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
Official title: A Phase I/II Trial of Bendamustine/Treanda®, Rituximab, Etoposide, and Carboplatin for Patients With Relapsed or Refractory Lymphoid Malignancies and Select Untreated Lymphomas (TREC)
Conditions: Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Summary: This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.
Interventions:
description: Given IV
name: Bendamustine Hydrochloride
other_name: Ribomustin
SyB L-0501
Treanda
type: Drug
description: Given IV
name: Carboplatin
type: Drug
description: Given IV
name: Rituximab
other_name: MOAB IDEC-C2B8
type: Biological
description: Given IV
name: Etoposide
other_name: Lastet
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
Study arms:
design_group_description: Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (chemotherapy and monoclonal antibody therapy)
design_group_type: Experimental
Sponsor: University of Washington
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸苯达莫司汀
lang: CN
name: Bendamustine Hydrochloride
lang: EN
name: ベンダムスチン塩酸塩
lang: JP
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04077866: B7-H3 CAR-T for Recurrent or Refractory Glioblastoma
Official title: B7-H3-Targeted Chimeric Antigen Receptor (CAR) T Cells in Treating Patients With Recurrent or Refractory Glioblastoma
Conditions: Recurrent Glioblastoma
Refractory Glioblastoma
Summary: This is a randomized, parallel-arm, phase I/II study to evaluate the safety and efficacy of B7-H3 CAR-T in between Temozolomide cycles comparing to Temozolomide alone in treating patients with glioblastoma that has come back or does not respond to the standard treatment. The antigen B7-H3 is highly expressed in glioblastoma of a subset of patients. B7-H3 CAR-T, made from isolated patient peripheral blood mononuclear cells, can specifically attack patient glioblastoma cells that expressing B7-H3.
Interventions:
description: Temozolomide is an FDA-approved drug that is given to patients
name: Temozolomide
other_name: TMZ
type: Drug
description: B7-H3-targeting CAR-T cells derived from patient own peripheral blood mononuclear cells will be given to patients via intracerebral injection though an Ommaya catheter
name: B7-H3 CAR-T
type: Biological
Study arms:
design_group_description: Temozolomide will be given to patients orally every 5 days with 23 days interval. The initial dose is 150 mg/m2 on the first day and 200 mg/m2 for the rest if no toxicity is seen. If 200 mg/m2 is toxic, the drug will return to 150 mg/m2 or will be stopped.
design_group_title: Temozolomide alone
design_group_type: Active Comparator
design_group_description: Temozolomide will be given to patients orally every 5 days with 23 days interval. The initial dose is 150 mg/m2 on the first day and 200 mg/m2 for the rest if no toxicity is seen. If 200 mg/m2 is toxic, the drug will return to 150 mg/m2 or will be stopped.<br/>The B7-H3 CAR-T will be administrated via intratumoral or Intracerebroventricular injection through an Ommaya catheter in between Temozolomide cycles. Temozolomide treatment in the cycles of B7-H3 CAR-T treatment will be stopped.
design_group_title: Temozolomide + B7-H3 CAR-T
design_group_type: Experimental
Sponsor: The Second Affiliated Hospital Zhejiang University
Collaborators: Boyuan Runsheng Pharmaceutical (Hangzhou) Co., Ltd.
Yinzhou People's Hospital
Huizhou Central People's Hospital
Drug name mappings:
name: Anti B7 H3 CAR-T-cell therapy (BoYuan RunSheng Pharma)
lang: EN
name: 替莫唑胺
lang: CN
name: Temozolomide
lang: EN
name: テモゾロミド
lang: JP