PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05443425: Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
Official title: Pilot Trial of Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
Conditions: Acute Graft Versus Host Disease
Hematopoietic and Lymphoid System Neoplasm
Summary: This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.
Interventions:
description: Given PO
name: Cholestyramine
other_name: Cholybar
Colestyramine
Duolite AP143 Resin
Questran
Questran Light
type: Drug
description: Given PO
name: Leflunomide
other_name: Arava
SU101
type: Drug
description: Given steroid therapy
name: Steroid Therapy
type: Drug
Study arms:
design_group_description: Patients receive steroid therapy at the discretion of the treating physician. Beginning within 3 days of starting steroids, patients receive leflunomide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients who respond to leflunomide treatment will be tapered off from day 29 until day 56.
design_group_title: Treatment of aGVHD (steroid therapy, leflunomide)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 考来烯胺
lang: CN
name: Cholestyramine
lang: EN
name: コレスチラミン
lang: JP
name: 来氟米特
lang: CN
name: Leflunomide
lang: EN
name: レフルノミド
lang: JP
Clinical trial NCT00988624: A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Official title: A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Conditions: Alzheimer's Disease
Huntington Disease
Summary: This study will evaluate four different modified release formulation to estimate the amount of dimebon available to the body relative to the current dimebon formulation that is given three times a day. The results of this study will help inform and guide further formulation development efforts with the ultimate goal of reducing dose frequency to once-a-day or twice-a-day.
Interventions:
description: Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
name: Dimebon IR Tablet
type: Drug
description: Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
name: Dimebon MR1
type: Drug
description: Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.
name: Dimebon MR2
type: Drug
description: Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
name: Dimebon MR3
type: Drug
description: Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
name: Dimebon MR4
type: Drug
Study arms:
design_group_title: Period 1
design_group_type: Experimental
design_group_title: Period 2
design_group_type: Experimental
design_group_title: Period 3
design_group_type: Experimental
design_group_title: Period 4
design_group_type: Experimental
design_group_title: Period 5
design_group_type: Experimental
Sponsor: Pfizer Inc.
Collaborators: MediVation, Inc.
Drug name mappings:
name: 盐酸地美波林
lang: CN
name: Dimebolin hydrochloride
lang: EN
Clinical trial NCT03110640: Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma
Official title: A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
Conditions: B-cell Adult Acute Lymphoblastic Leukemia
B-cell Chronic Lymphocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Hematopoietic/Lymphoid Cancer
Refractory Chronic Lymphocytic Leukemia
Summary: This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Interventions:
description: Ex vivo-expanded autologous T cells modified to express CD19 CAR
name: anti-CD19 CAR-T
type: Biological
description: Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
name: Fludarabine
type: Drug
description: Patients were given cyclophosphamide 500mg/m2/day on day -4.
name: Cyclophosphamide
type: Drug
Study arms:
design_group_description: All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
design_group_title: CD9CAR-T transfer
design_group_type: Experimental
Sponsor: The First Affiliated Hospital of Wenzhou Medical College
Collaborators: The Second Affiliated Hospital of Nanchang University
Hrain Biotechnology Co., Ltd.
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: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 雷尼基奥仑赛
lang: CN
name: HR-001
lang: EN
Clinical trial NCT01483846: Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers
Official title: A Phase 1b, Single-Site, Randomized, Double-Blind,Placebo-Controlled, Dose-Escalation Study: Safety, Pharmacokinetics, and Antihyperalgesic Activity of Multiple Doses of AV-101 on Capsaicin-Induced Pain in Healthy Volunteers
Conditions: Neuropathic Pain
Summary: This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.
Interventions:
description: Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.
name: AV-101
other_name: L-4-Cl-KYN
type: Drug
description: Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.
name: Placebo
other_name: microcrystalline cellulose
type: Drug
Study arms:
design_group_description: Subjects will be randomized into one of three dose cohorts (360, 1,080, and 1,440 mg) to receive a daily oral dose for 14 consecutive days. Each cohort will have 12 subjects on active drug and 4 subjects on placebo.<br/>--------------------------------------------------------------------------------
design_group_title: AV-101
design_group_type: Experimental
design_group_description: Subjects will be randomized into one of three cohorts (360, 1,080, and 1,440 mg) to receive a daily oral dose for 14 consecutive days. Each cohort will have 12 subjects on active drug and 4 subjects on placebo.
design_group_title: microcrystalline cellulose
design_group_type: Placebo Comparator
Sponsor: Vistagen Therapeutics, Inc.
Collaborators: Cato Research LLC
National Institute on Drug Abuse
Drug name mappings:
name: 4-Chlorokynurenine
lang: EN
Clinical trial NCT05160545: A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Breast Cancer
Official title: An Open-Label, Multi-Center, Phase I Study I Study to Evaluate the Safety, Tolerability, Pharmacokinetic/Phamacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Locally Advanced or Metastatic Breast Cancer
Conditions: Breast Cancer
Summary: In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in participants with locally advanced or metastatic Breast Cancer will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035.
Interventions:
description: Administration by intravenous infusion
name: GNC-035
type: Drug
Study arms:
design_group_description: Patients receive GNC-035 intravenous infusion (IV, QW) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles
design_group_title: GNC-035
design_group_type: Experimental
Sponsor: Sichuan Baili Pharmaceuticals Co.,Ltd
Collaborators: Baili Bio Chengdu Pharmaceutical Co. Ltd.
Drug name mappings:
name: GNC-035四特异性抗体(百利药业)
lang: CN
name: Nebratamig
lang: EN
Clinical trial NCT06258304: A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Official title: A Phase 1 Dose Escalation and Expansion Study of GIGA-564, a Minimally Blocking Anti-CTLA-4 Monoclonal Antibody, in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Conditions: Advanced or Metastatic Solid Tumor Malignancies
Summary: The purpose of this study is to assess the safety and tolerability of GIGA-564 and identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) level(s) of GIGA-564 in participants with metastatic or locally advanced solid tumor malignancies.
Interventions:
description: Administered by intravenous infusion
name: GIGA-564
type: Drug
description: Administered by intravenous infusion
name: GIGA-564
type: Drug
Study arms:
design_group_description: Up to 5 dose levels [0.3, 1.0, 3.0, 10.0, and 20.0 milligrams per kilogram (mg/kg)] will be evaluated sequentially. Participants will receive GIGA-564 intravenously over at least 60 minutes on Day 1 of every 3 weeks (3 weeks = 1 cycle) for up to 4 cycles until time of confirmed disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
design_group_title: GIGA-564: Dose Escalation (Phase 1A)
design_group_type: Experimental
design_group_description: Dose expansion (Phase 1B) of selected dose levels may be initiated following the preliminary clearance of those specified dose levels from the dose escalation (Phase 1A) as determined by the Sponsor and SRC. Participants will receive up to 4 cycles of one of up to three tolerable dose levels of GIGA-564. GIGA-564 will be given intravenously over at least 60 minutes on Day 1 of every 3 weeks (3 weeks = 1 cycle) for up to 4 cycles until time of confirmed disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
design_group_title: GIGA-564: Dose Expansion (Phase 1B)
design_group_type: Experimental
Sponsor: GigaGen, Inc.
Collaborators: National Cancer Institute
Drug name mappings:
name: GIGA-564
lang: EN
Clinical trial NCT01273103: A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult Subjects
Official title: An Open Label, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 200 mg, Administered as an Oral Suspension to Healthy Adult Subjects
Conditions: Infection, Human Immunodeficiency Virus
Summary: This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be collected. Subjects will be required to remain in the unit until the radiocarbon excreted falls to less than or equal to 1% of the administered dose for two consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and physical examinations as indicated.
Interventions:
description: single oral suspension dose of [14C]- GSK2248761 200 mg
name: 200mg [14C]- GSK2248761
type: Drug
Study arms:
design_group_description: [14C]- GSK2248761 200 mg
design_group_title: Treatment
design_group_type: Experimental
Sponsor: ViiV Healthcare Ltd.
Collaborators: GSK Plc
Drug name mappings:
name: Fosdevirine
lang: EN
Clinical trial NCT03246659: Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC
Official title: Phase I Clinical Trial Using a Novel CCK-2/Gastrin Receptor-localizing Radiolabelled Peptide Probe for Personalized Diagnosis and Therapy of Patients With Progressive or Metastatic Medullary Thyroid Carcinoma
Conditions: Medullary Thyroid Carcinoma
Summary: The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to investigate the IMP, namely 111In-CP04.
The study consists of preclinical (to establish a clinically useful formulation for the radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of the project is to establish the safety of i.v. administration of a high peptide amount and to assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To achieve this, the following study design has been accepted: the first 4 patients will receive 2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount (for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.
It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for a specific non-invasive staging and follow-up of patients with MTC, and treatment of recurrent and disseminated disease will be more efficient with minimized nephro- and myelotoxicity (if 111In labelled).
Interventions:
description: Radiopharmaceutical preparation
name: 111In-CP04
other_name: 111In-CP04 (DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2
type: Drug
description: Radiopharmaceutical preparation with co-administration of gelofusine/gelaspan
name: 111In-CP04 with co-administration of gelofusine/gelaspan
other_name: 111In-CP04 (DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2
type: Drug
Study arms:
design_group_description: 111In-CP04
design_group_title: arm 1
design_group_type: Experimental
design_group_description: 111In-CP04 with co-administration of gelofusine/gelaspan
design_group_title: arm 2
design_group_type: Experimental
Sponsor: Azienda Ospedaliero-Universitaria di Modena
Collaborators: Medical University of Innsbruck
Universitätsklinikum Freiburg
Erasmus Universitair Medisch Centrum Rotterdam
Uniwersytet Jagiellonski
UMC Ljubljana
Drug name mappings:
name: 111In-CP-04
lang: EN
name: 琥珀酰明胶
lang: CN
name: Succinylated Gelatin
lang: EN
Clinical trial NCT02593370: Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block
Conditions: Hip Fractures
Anesthesia Local
Pain, Perioperative
Summary: The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.
Interventions:
name: Lidocaine-epinephrine added gadoterate meglumine
type: Drug
Study arms:
design_group_description: Use of ultrasound/MR image fusion guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine).
design_group_title: Suprasacral Parallel Shift guided by US/MR image fusion
design_group_type: Experimental
design_group_description: Use of ultrasound guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine).
design_group_title: Suprasacral Parallel Shift guided by US
design_group_type: Active Comparator
Sponsor: Århus Universitetshospital
Collaborators: Århus Universitetshospital
Drug name mappings:
name: 肾上腺素/盐酸利多卡因
lang: CN
name: Epinephrine/Lidocaine Hydrochloride
lang: EN
name: リドカイン塩酸塩/アドレナリン
lang: JP
name: 钆特酸葡胺
lang: CN
name: Gadoterate Meglumine
lang: EN
name: ガドテル酸メグルミン
lang: JP
Clinical trial NCT04447781: Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19
Official title: A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
Conditions: Coronavirus Infection
SARS-CoV 2
Summary: This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Interventions:
description: - Manufacturer: Inovio Pharmaceuticals Inc.
name: INO-4800
type: Biological
description: - Manufacturer: Inovio Pharmaceuticals Inc.
name: CELLECTRA® 2000
type: Device
description: - Manufacturer: Inovio Pharmaceuticals Inc.
name: Saline-sodium citrate (SSC) buffer
other_name: Placebo
type: Other
Study arms:
design_group_description: * Number of Subjects: 20 subjects<br/>* ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
design_group_title: Group 1 (Part A)
design_group_type: Experimental
design_group_description: * Number of Subjects: 20 subjects<br/>* ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
design_group_title: Group 2 (Part A)
design_group_type: Experimental
design_group_description: * Number of Subjects: 90 subjects<br/>* ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
design_group_title: Group 3 (Part B)
design_group_type: Experimental
design_group_description: * Number of Subjects: 30 subjects<br/>* ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
design_group_title: Group 4 (Part B, Placebo)
design_group_type: Placebo Comparator
Sponsor: International Vaccine Institute
Collaborators: Inovio Pharmaceuticals, Inc.
Coalition for Epidemic Preparedness Innovations
Drug name mappings:
name: INO-4800
lang: EN
Clinical trial NCT03153202: Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Official title: Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Conditions: Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Summary: The purpose of this study is to determine the most appropriate dose for the combination of ibrutinib and pembrolizumab and to see if the combination is active for the disease. The study will monitor for any side effects and if the combination of ibrutinib and pembrolizumab works in the cancers being studied.
There will be 2 experimental drugs given to the subject in this study. One experimental drug used in this study is called ibrutinib and the second is called pembrolizumab.
This is the first time that ibrutinib will be used in combination with pembrolizumab. This combination is considered experimental. Experimental means that it is still being tested to see if it is safe and effective. Ibrutinib is a new drug known as a 'Bruton's Tyrosine Kinase (BTK) inhibitor'. Ibrutinib blocks an enzyme (protein) that affects how certain types of blood cancer cells grow and survive. Blocking this enzyme is a very important mechanism in killing blood cancer cells. Ibrutinib has been approved in the United States, Israel, and the European Union for use in adult patients with mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Pembrolizumab is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with melanoma (skin cancer) who have received prior treatments. Pembrolizumab is not FDA approved to treat patients with chronic lymphocytic leukemia [CLL] and mantle cell lymphoma [MCL].
Interventions:
description: once daily oral intake ibrutinib
name: Ibrutinib
type: Drug
description: 200mg IV pembrolizumab on Day 1 of each cycle
name: Pembrolizumab
type: Drug
Study arms:
design_group_description: Participants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL
design_group_title: Participants with CLL
design_group_type: Experimental
design_group_description: Participants with relapsed/ refractory Mantle Cell Lymphoma (MCL)
design_group_title: Participants with MCL
design_group_type: Experimental
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 伊布替尼
lang: CN
name: Ibrutinib
lang: EN
name: イブルチニブ
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP