chufangao/CTO huggingface dataset:
Clinical trial NCT03906526: A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
Official title: A Phase 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Nivolumab in Subjects With Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 15.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-03
Primary completion date: 2022-01-24
Completion date: 2022-01-24
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT04578015: A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
Official title: A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: After screening many patients for BV, it was determined that the rate of BV is less in our population that the 30% rate mentioned in the literature. It was determined that completing the study will not be feasible due to cost and time constraints.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-26
Primary completion date: 2022-02-09
Completion date: 2022-02-09
Baseline population: Baseline analysis population data was not obtained as participants assigned to the treatment and placebo group did not complete the study, and this study was terminated due to lack of participant enrollment before data could be collected. No baseline data was collected.
Plan to share individual participant data: NO
Clinical trial NCT02408328: Management of Apnea in Late Preterm and Term Infants
Official title: Management of Apnea in Late Preterm and Term Infants
Sponsor: Boston Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Transition to new position
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2020-12-31
Completion date: 2021-05-31
Clinical trial NCT04713176: Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
Official title: A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients
Sponsor: Daewoong Pharmaceutical Co. LTD. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Termination of study due to sponsor's internal decision
Enrollment: 240.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-02
Primary completion date: 2022-05-02
Completion date: 2022-12-09
Clinical trial NCT04019769: Glutamine Supplementation in People With Immune Dysregulation
Official title: Phase 1 Trial of Glutamine Supplementation in Patients With Immune Dysregulation
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: PI left NIH. No subjects enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-12
Primary completion date: 2021-01-01
Completion date: 2021-01-01
Clinical trial NCT04511819: Losmapimod Safety and Efficacy in COVID-19
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Losmapimod in Adult Subjects With COVID-19 (LOSVID STUDY)
Acronym: LOSVID
Sponsor: Fulcrum Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated due to the rapidly evolving environment for the treatment of Covid-19 and ongoing challenges to identify and enroll qualified patients to participate.
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-28
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Baseline population: Full Analysis Set: included all participants who were randomized and received any study drug.
Plan to share individual participant data: NO
Clinical trial NCT02382549: A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib
Official title: A TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A HELPER PEPTIDE VACCINE PLUS COMBINATION OF BRAF INHIBITION AND MEK INHIBITION (MEL61)
Acronym: Mel61
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The study was terminated because of slow accruals.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-30
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Clinical trial NCT04412057: Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
Sponsor: Avalo Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-17
Primary completion date: 2020-12-14
Completion date: 2021-01-19
Baseline population: Randomized Analysis Set
Limitations and caveats: The study was designed to use broad eligibility criteria including patients who received high-flow oxygen or positive-pressure oxygen prior to randomization. Some overlap was expected between the entry criteria and the primary endpoint. Therefore patients who were in respiratory failure before dosing or who required an elevation in their ventilation support were excluded (N=20). In addition, to increase statistical power, a 1-sided χ2 test was used.
Plan to share individual participant data: NO
Clinical trial NCT03537157: A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention
Official title: A Phase II, Multicentre, Double-blind, Randomised, Placebo-controlled Study of Rifaximin Delayed Release 400 mg Tablet: Clinical Efficacy and Safety in the Prevention of Post-operative Endoscopic Crohn's Disease Recurrence
Acronym: STOP-PER
Sponsor: Alfasigma S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The decision to prematurely close the trial recruitment period was taken due to the difficulties in the recruitment of patients. This decision has not been triggered by any unexpected safety signals identified during the study conduction.
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-16
Primary completion date: 2020-07-15
Completion date: 2020-07-29
Plan to share individual participant data: NO
Clinical trial NCT03444870: Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).
Enrollment: 1053.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-06
Primary completion date: 2022-12-28
Completion date: 2023-02-17
Baseline population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04510207: A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
Official title: Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
Acronym: COVID-19
Sponsor: China National Biotec Group Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 44101.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-07-16
Primary completion date: 2021-06-16
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT03998436: Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers
Sponsor: Novalead Pharma Private Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 176.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-26
Primary completion date: 2021-08-19
Completion date: 2021-12-06
Plan to share individual participant data: NO
Clinical trial NCT03736629: Azithromycin Treatment for the Airway Microbiome in Asthma
Official title: The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inability to accrue patients, particularly after COVID pandemic.
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-01
Primary completion date: 2021-03-01
Completion date: 2022-06-01
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: YES
IPD sharing description: We will share individual participant data that is de-identified available to all qualified investigators
IPD time frame: Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database (e.g., sequencing information will be deposited in a genetics bio-bank).
IPD access criteria: All qualified investigators who sign appropriate data use agreements and material transfer agreements with the University of Chicago and Northwestern University
Clinical trial NCT06138327: A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
Official title: A Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 2-Period Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Oral Administration of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease (NAFLD) And Hyperoxaluria
Sponsor: BioMarin Pharmaceutical (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The study was withdrawn because BioMarin decided to end the overall development program. The study withdrawal was not due to any patient safety concerns.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-09-26
Primary completion date: 2024-03-25
Completion date: 2024-03-25
Clinical trial NCT03437044: Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI
Official title: A Randomized Comparison of Platelet Inhibition Using a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Prior Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-6 Study
Acronym: OPTIMUS-6
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-14
Primary completion date: 2019-06-27
Completion date: 2020-06-27
Plan to share individual participant data: NO
Clinical trial NCT04528199: [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Official title: A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The Principal Investigator decided to terminate the study because the PI left Hopkins.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-01
Primary completion date: 2023-04-21
Completion date: 2023-04-21
Clinical trial NCT03682744: CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
Official title: Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Unable to enroll subjects
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-13
Primary completion date: 2020-12-31
Completion date: 2021-03-31
Clinical trial NCT05842967: A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
Official title: A PHASE 3 PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE
Acronym: MONET
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 886.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-05-11
Primary completion date: 2024-03-18
Completion date: 2024-03-18
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04607005: Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study
Acronym: MERIT
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 169.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-08
Primary completion date: 2023-04-12
Completion date: 2023-04-12
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT04346615: Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen
Official title: BHV3500-203: Phase 2/3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of Zavegepant (BHV-3500) Intranasal (IN) for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Lack of enrollment due to evolution of COVID-19 pandemic with reduction in patients at risk for severe disease and growing number of effective alternative therapies
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-25
Primary completion date: 2022-04-29
Completion date: 2022-04-29
Baseline population: Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo)
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03629015: Safety Study of Stemchymal® in Acute Liver Failure
Official title: The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
Acronym: ALF
Sponsor: Steminent Biotherapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Corporate strategic consideration
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-01
Primary completion date: 2020-05-18
Completion date: 2020-05-18
Plan to share individual participant data: NO
Clinical trial NCT03716076: Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Official title: The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
Acronym: CaRDIO
Sponsor: University of British Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-01
Primary completion date: 2019-06-15
Completion date: 2020-04-24
Limitations and caveats: No data exists that stratifies risk by measuring absolute Tp-e change We excluded patients with low repolarization reserves, or a resistance to oxytocin. We also excluded emergent C-sections, combined spinal/epidurals, and General Anesthesia
Plan to share individual participant data: NO
Clinical trial NCT03149640: Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia
Official title: Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia
Acronym: AMIKINHAL
Sponsor: University Hospital, Tours (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 850.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-19
Primary completion date: 2021-03-09
Completion date: 2021-06-17
Plan to share individual participant data: NO
Clinical trial NCT03927690: Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
Official title: A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 91.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-24
Primary completion date: 2022-06-17
Completion date: 2022-08-31
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT02219711: Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
Official title: A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
Sponsor: Mirati Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 193.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-08-31
Primary completion date: 2022-04-27
Completion date: 2022-04-27
Clinical trial NCT04617860: Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
Official title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease
Sponsor: Wave Life Sciences Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-24
Primary completion date: 2021-04-29
Completion date: 2021-04-29
Clinical trial NCT05114460: Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
Official title: The Ability of Vaped Marijuana to Reduce the Severity of Naloxone-Precipitated Withdrawal
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.
Enrollment: 32.0 (ESTIMATED)
Number of arms: 6.0
Start date: 2021-11-01
Primary completion date: 2024-09-30
Completion date: 2024-12-30
Plan to share individual participant data: NO
Clinical trial NCT03515200: Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia
Official title: A Phase I Study of Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to departure of PI from St. Jude
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-20
Primary completion date: 2020-07-29
Completion date: 2020-07-29