chufangao/CTO huggingface dataset:
Clinical trial NCT03523767: Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
Official title: Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Early termination related to COVID pandemic
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-07
Primary completion date: 2020-02-07
Completion date: 2020-02-07
Plan to share individual participant data: NO
Clinical trial NCT01959139: S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
Official title: S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 126.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-01-23
Primary completion date: 2019-04-30
Completion date: 2023-11-09
Clinical trial NCT05011513: Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population
Enrollment: 1440.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-25
Primary completion date: 2022-07-25
Completion date: 2022-07-25
Baseline population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses.
Limitations and caveats: In participant flow, there was discontinuations due to AE, which was captured under Death as reason for discontinuation. Adverse event was COVID-19 pneumonia and the participant died due to that event and discontinued study.
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 NCT06021119: Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System
Official title: Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System
Sponsor: Ain Shams University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-23
Primary completion date: 2023-04-21
Completion date: 2023-04-21
Plan to share individual participant data: NO
Clinical trial NCT05029856: Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults
Official title: A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults
Sponsor: Novavax (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Study never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-02-04
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Clinical trial NCT03788291: Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Official title: Phase II Study of Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated CLL/SLL
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-25
Primary completion date: 2023-05-19
Completion date: 2023-05-19
Clinical trial NCT03750773: Gabapentin for Relief of Immediate Postoperative Pain
Official title: GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
Acronym: GRIPP
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-02
Primary completion date: 2020-03-31
Completion date: 2020-04-30
Plan to share individual participant data: NO
Clinical trial NCT04411082: A Study of IMR-687 in Subjects With Beta Thalassemia
Official title: A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects With Beta Thalassemia
Sponsor: Imara, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: IMR-BTL-201demonstrated that while IMR-687 was generally well-tolerated, it failed to show any meaningful benefit in transfusion burden or improvement in most disease-related biomarkers. So, the sponsor has decided to discontinue this study
Enrollment: 122.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-16
Primary completion date: 2022-03-11
Completion date: 2022-05-04
Baseline population: Safety Analysis Set
Clinical trial NCT03089619: Alveolar Management Following Teeth Extraction
Official title: A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning
Sponsor: University Medicine Greifswald (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulties in recruiting of suitable patients, bad compliance of patients
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-02
Primary completion date: 2022-01-14
Completion date: 2023-05-08
Plan to share individual participant data: NO
IPD sharing description: IPD will not be shared in accordance with medical data protection regulations.
Clinical trial NCT02855268: Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients With Alport Syndrome
Acronym: HERA
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The results of the futility analysis led to the study termination. No unexpected safety findings were identified.
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-02
Primary completion date: 2022-09-22
Completion date: 2022-09-22
Baseline population: Analysis was performed on all randomized population.
Limitations and caveats: Due to early study termination, Stage 2/Cohort 2 was not conducted. In Stage 1 analysis of DB period was performed until 48 weeks. In Stage 1 OL period, only safety data was collected and assessed.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04697485: Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus
Official title: Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus: A Pilot Trial
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Enrollment and funding challenges
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-08
Primary completion date: 2022-01-01
Completion date: 2022-03-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03505021: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Official title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Acronym: REFALS
Sponsor: Orion Corporation, Orion Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 496.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-21
Primary completion date: 2020-07-23
Completion date: 2020-07-23
Baseline population: Intention-to-treat (ITT) dataset, including all randomised subjects, was used for the primary evaluation. Sensitivity analyses using full analysis set (FAS) and two per-protocol (PP) datasets (up to 12 weeks and up to 48 weeks) were performed. FAS included all treated subjects with at least one post baseline SVC measurement. PP dataset included all randomised subjects except subjects with relevant major protocol deviations.
Clinical trial NCT03319823: Treating Nocturnal Hypertension and Nocturia in African American Men
Official title: A Pilot Study: Treating Nocturnal Hypertension and Nocturia in African American Men
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Due to the Pandemic, we decided to end this study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-25
Primary completion date: 2019-02-13
Completion date: 2021-02-01
Plan to share individual participant data: NO
Clinical trial NCT01036087: Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
Official title: Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-11-30
Primary completion date: 2016-02-11
Completion date: 2022-08-09
Clinical trial NCT03718429: Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies
Official title: Pharmacodynamic Effects of Low-dose Rivaroxaban in Combination With Antiplatelet Therapies in Patients With Coronary and Peripheral Artery Disease Manifestations
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-14
Primary completion date: 2020-02-13
Completion date: 2020-08-30
Baseline population: Baseline characteristics are provided for each one of the initial 4 treatment cohorts. These already includes patients in other treatment arms were rivaroxaban 2.5 mg was added and aspirin stopped in each patient of each cohort.
Plan to share individual participant data: NO
IPD sharing description: No sharing is planned
Clinical trial NCT03972215: Berberine Hyperglycemic Clamp
Official title: Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man
Acronym: BBR HC
Sponsor: Beijing Tongren Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2020-01-20
Completion date: 2020-02-17
Plan to share individual participant data: NO
Clinical trial NCT04296942: BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
Official title: A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: One participant was accrued, and the study was stopped due to new safety data from the company for M7824 and slow accrual.
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-04
Primary completion date: 2021-10-22
Completion date: 2021-10-22
Baseline population: No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
Plan to share individual participant data: NO
Clinical trial NCT05576662: Paxlovid for Treatment of Long Covid
Official title: Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC
Acronym: STOP-PASC
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 168.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-08
Primary completion date: 2023-08-14
Completion date: 2023-09-12
Plan to share individual participant data: NO
IPD sharing description: Currently, there is no plan for data sharing.
Clinical trial NCT04607252: Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
Official title: Comparing Metformin Plus Megestrol Acetate with Megestrol Acetate Alone As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
Sponsor: Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-11
Primary completion date: 2021-06-03
Completion date: 2021-06-03
Plan to share individual participant data: NO
IPD sharing description: Data will be shared with other researchers without patients' personal information after all the findings being published.
Clinical trial NCT04085601: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
Official title: A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsor: Apellis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-27
Primary completion date: 2021-06-23
Completion date: 2021-06-23
Baseline population: The intent-to-treat (ITT) set included all subjects assigned to treatment.
Clinical trial NCT05728736: Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
Official title: Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was terminated due to enrollment difficulties and the inability to obtain necessary study supplies. Five participants signed consent; however, no one was randomized. The study was officially terminated with the funding source on 10/04/2023.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-01
Primary completion date: 2023-09-27
Completion date: 2023-10-04
Clinical trial NCT04314856: Novel Clinical Target in Fragile X Syndrome
Official title: Sigma-1 Receptors: A Novel Clinical Target in Fragile X Syndrome
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Principal investigator left institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-12
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT06438354: Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.
Official title: Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial.
Sponsor: University of Witten/Herdecke (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-01
Primary completion date: 2023-10-30
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT04034004: Chronic Low Back Pain and Meditation
Official title: The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2022-12-22
Completion date: 2022-12-22
Baseline population: The analysis population was not different from the assignment in participant flow.
Limitations and caveats: The most significant limitation was performing highly invasive pain and pharmacologic testing during the coronavirus pandemic.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04508621: A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
Acronym: RALLY
Sponsor: Tonix Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 514.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-22
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Limitations and caveats: Recruitment during COVID-19 pandemic
Clinical trial NCT03536559: Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis
Official title: A Phase 2, Randomized, DB-PC, Parallel Group Study for the Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of CNM-Au8 For Remyelination In Multiple Sclerosis
Acronym: VISIONARY-MS
Sponsor: Clene Nanomedicine (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19 related enrollment challenges.
Enrollment: 73.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-23
Primary completion date: 2022-04-27
Completion date: 2022-07-12
Plan to share individual participant data: NO
Clinical trial NCT04147234: A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)
Official title: Phase I, First in Human Trial Evaluating BI 1387446 Alone and in Combination With Ezabenlimab (BI 754091) in Solid Tumors
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-09
Primary completion date: 2022-11-15
Completion date: 2024-03-21
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT03426345: Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Relamorelin program is being terminated solely based on a business decision
Enrollment: 311.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-16
Primary completion date: 2020-07-16
Completion date: 2020-07-16
Baseline population: Intent-to-treat (ITT) Population included all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT03044314: Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension
Official title: Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension (The OVATION Study)
Acronym: OVATION
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: slow enrollment
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-21
Primary completion date: 2019-06-20
Completion date: 2020-05-19
Baseline population: Participants who completed the study.
Plan to share individual participant data: NO
Clinical trial NCT02302508: Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients
Official title: PANDDA Study: Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients
Acronym: PANDDA
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-09-01
Primary completion date: 2020-12-31
Completion date: 2021-12-31
Clinical trial NCT01998035: Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
Official title: Phase I/IIa Study of the Oral 5-Azacitidine in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: PI left institution
Enrollment: 58.0 (ACTUAL)
Number of arms: 7.0
Start date: 2013-11-30
Primary completion date: 2020-01-06
Completion date: 2020-01-06
Baseline population: Baseline characteristics and study results were only collected as the combined total from participants per study phase. Baseline characteristics were not collected per dose level and thus cannot be reported per dose level.~Baseline characteristics were collected from all participants who enrolled/consented in Phase 1 (n=33) and Phase 2 (n=25). Of those 33 enrolled in Phase 1, 26 received the study interventions and only those 26 are counted in the Participant Flow.
Plan to share individual participant data: NO