Clinical trials: Chronic Myeloid Leukemia, BCR/ABL-Positive
Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.
- Conditions
- Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia, Blast Phase Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia
- Trial name
- NCT03934372
- Testing
- Ponatinib
- Where
- 23 sites in Belgium, France and 5 more
- Volunteers
- 70 people
- Sponsor
- Incyte Biosciences International Sàrl
CHRONIC MYELOGENOUS LEUKEMIA
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib.
- Trial name
- NCT00760877
- Testing
- Nilotinib, Imatinib
- Where
- 30 sites in Argentina, Australia and 4 more
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia - Chronic Phase
Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia
DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus Dasatinib as upfront therapy for patient with chronic myeloid leukemia.
- Trial name
- DANIN (NCT03079505)
- Testing
- Dasatinib 100 MG [Sprycel], Nilotinib 150mg oral capsule [Tasigna]
- Where
- Qatar
- Volunteers
- 10 people
- Sponsor
- Hamad Medical Corporation
Chronic Myelogenous Leukemia
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).
- Trial name
- NCT04948333
- Testing
- ABL001 40mg BID, ABL001 80mg QD, ABL001 200mg QD
- Where
- 48 sites in Argentina, Austria and 14 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
CML (Chronic Myelogenous Leukemia), Chronic Phase CML
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without…
- Trial name
- CML (NCT06787144)
- Testing
- ELVN-001
- Where
- 4 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Enliven Therapeutics
CML
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
- Trial name
- ENESTgoal (NCT01744665)
- Testing
- nilotinib
- Where
- 54 sites in United States
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy…
- Trial name
- NCT00375219
- Testing
- Omacetaxine mepesuccinate
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 103 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Hematologic Malignancies
GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).
- Trial name
- NCT03320642
- Testing
- Itacitinib, Calcineurin inhibitor
- Where
- 17 sites in United States, France and 2 more
- Volunteers
- 84 people
- Sponsor
- Incyte Corporation
CML, Philadelphia Chromosome Positive (Ph+)
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
- Conditions
- CML, Philadelphia Chromosome Positive (Ph+), Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
- Trial name
- MACS1148 (NCT01131325)
- Testing
- nilotinib
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
Myeloid Leukemia, Philadelphia Positive
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
The aim of this study is to support development of asciminib in the pediatric population (1 to <18 years) previously treated with one or more TKIs.
- Trial name
- NCT04925479
- Testing
- Asciminib Pediatric formulation group, Asciminib Adult formulation group
- Where
- 39 sites in United States, China and 12 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)
The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.
- Trial name
- NCT01394666
- Volunteers
- 150 people
- Sponsor
- Bristol-Myers Squibb
Chronic Myeloid Leukemia
KRT-232 and TKI Study in Chronic Myeloid Leukemia
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor…
- Trial name
- NCT04835584
- Testing
- KRT-232, Dasatinib, Nilotinib
- Where
- 26 sites in United States, Canada and 6 more
- Volunteers
- 109 people
- Sponsor
- Kartos Therapeutics, Inc.
Chronic Myeloid Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Iclusig PMS in CML or Ph+ALL Patients
This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP).
- Trial name
- NCT03709017
- Testing
- Ponatinib
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Chronic Myeloid Leukemia
TGRX-678 Pharmacokinetic Mass Balance
This is a pharmacokinetic study for [14C]TGRX-678 on mass balance to evaluate distribution, metabolism and excretion of TGRX-678, a tyrosine kinase inhibitor indicated for treatment of chronic myeloid leukemia.
- Trial name
- NCT06986772
- Testing
- [14C]TGRX-678
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shenzhen TargetRx Co., Ltd.
Chronic Myelogenous Leukemia
Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
The study was a local multicentric, open-label, non-randomized phase II study of nilotinib as a first line treatment in adult patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) and chronic phase myeloid leukemia…
- Trial name
- NCT01274351
- Testing
- Nilotinib
- Where
- 13 sites in Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of…
- Trial name
- NCT00101660
- Testing
- Dasatinib
- Where
- 85 sites in United States, Australia and 20 more
- Volunteers
- 387 people
- Sponsor
- Bristol-Myers Squibb
CML (Chronic Myelogenous Leukemia)
Vididencel in CML-CP Patients With MRD
The main purpose of the trial is to evaluate the safety and potential side effects of cell therapy vididencel in Chronic Myeloid Leukemia (CML) participants with measurable residual disease (MRD) unable to stop treatment with…
- Trial name
- NCT07651878
- Testing
- vididencel
- Where
- Norway
- Volunteers
- 24 people
- Sponsor
- Mendus
Leukemia, Lymphocytic, Acute, Leukemia, Nonlymphocytic, Acute
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies.
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Nonlymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes
- Trial name
- NCT00246662
- Testing
- Vosaroxin
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Sunesis Pharmaceuticals
Leukemia, Myelogenous, Chronic
A Bioequivalence Study of Dasatinib Tablet
This is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Trial name
- NCT05640804
- Testing
- CTTQ Dasatinib tablet, Sprycel Dasatinib tablet
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Leukemia, Myeloid, Chronic-Phase
Treatment Patterns and Key Endpoints Among Patients With Chronic-Phase Chronic Myeloid Leukemia in a Community Oncology Setting
This was a retrospective observational study to examine treatment patterns, molecular testing patterns, treatment response, and clinical outcomes among patients initiating first-line (1L) tyrosine kinase inhibitor (TKI) treatment…
- Trial name
- NCT07374120
- Where
- United States
- Volunteers
- 1,480 people
- Sponsor
- Novartis Pharmaceuticals