Clinical trials: Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Myelogenous Leukemia, Chronic
A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
It is an open-label, randomized, multi-center study. The efficacy and safety of two flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400 mg once daily in newly diagnosed (within 6 months)…
- Trial name
- NCT01503502
- Testing
- flumatinib, imatinib
- Where
- 5 sites in China
- Volunteers
- 150 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained…
- Trial name
- ENESTPath (NCT01743989)
- Testing
- Nilotinib
- Where
- 208 sites in Austria, Belgium and 19 more
- Volunteers
- 620 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Chronic Myeloid
A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany
The aim of this study is to assess the real-world effectiveness of asciminib in Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) patients who were either newly diagnosed or previously…
- Trial name
- ASC2ADHERE (NCT07549516)
- Where
- 69 sites in Germany
- Volunteers
- 380 people
- Sponsor
- Novartis Pharmaceuticals
Philadelphia Chromosome Positive, Chronic Myelogenous Leukemia in Chronic Phase
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response
To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal…
- Trial name
- MACS0911 (NCT01043874)
- Testing
- Nilotinib
- Where
- 20 sites in Japan
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
This trial is a multicenter, open label, randomized phase III clinical study that evaluates the efficacy of oral HS-10382 versus investigator selected TKIs (imatinib, nilotinib, dasatinib, and flumatinib) in newly diagnosed…
- Trial name
- NCT07885293
- Testing
- HS-10382, Imatinib, Dasatinib
- Where
- China
- Volunteers
- 408 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Leukemia
Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with newly diagnosed chronic…
- Trial name
- NCT00809211
- Testing
- nilotinib, cytogenetic analysis, mutation analysis
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 40 people
- Sponsor
- Cancer Trials Ireland
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 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
Myelogenous Leukemia
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic…
- Trial name
- ENEST (NCT00519090)
- Testing
- Imatinib, Nilotinib (AMN107)
- Where
- 80 sites in United States, Australia and 8 more
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP.
- Trial name
- NCT04971226
- Testing
- Imatinib, Nilotinib, Bosutinib
- Where
- 110 sites in United States, Australia and 27 more
- Volunteers
- 405 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia (CML)
Nilotinib, for Patients With CML-CP or CML-AP
The purpose of this Cohort Treatment Plan is to allow access to Nilotinib for eligible patients diagnosed with imatinib-intolerant and/or resistant Philadelphia Chromosome positive (Ph+) Chronic Myelogenous Leukemia in Chronic…
- Trial name
- NCT04518644
- Testing
- Nilotinib
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
The study is designed to compare the efficacy of ELVN-001 versus Investigator-selected tyrosine kinase inhibitor (TKI) for adults with previously treated chronic myeloid leukemia in the chronic phase (CP-CML).
- Conditions
- Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, Chronic Phase Chronic Myeloid Leukemia, BCR::ABL1 Positive CML
- Trial name
- ENABLE-2 (NCT07905183)
- Testing
- ELVN-001, TKI
- Volunteers
- 450 people
- Sponsor
- Enliven Therapeutics
Chronic Myeloid Leukemia
Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients
The study will compare the efficacy and safety of Nilotinib versus Imatinib in newly diagnosed Chinese patients with CML-CP.
- Trial name
- NCT01275196
- Testing
- Nilotinib, Imatinib
- Where
- 12 sites in China
- Volunteers
- 267 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to…
- Trial name
- MACS0999 (NCT00980018)
- Testing
- Nilotinib
- Where
- 23 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Myelogenous Leukemia, Chronic
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+)…
- Trial name
- ENESTnd (NCT00471497)
- Testing
- nilotinib, imatinib
- Where
- 213 sites in United States, Argentina and 33 more
- Volunteers
- 846 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+
It is an open-label, randomized, double blind, placebo-controlled parallel-group, multi-center study to evaluate the efficacy and safety of Compound realgar formula Realgar-Indigo naturalis Tablet combined with Imatinib will be…
- Trial name
- NCT01755325
- Testing
- Compound realgar natural indigo Tablet
- Where
- 13 sites in China
- Volunteers
- 680 people
- Sponsor
- Junmin Li
Chronic Myelogenous Leukemia in Chronic Phase
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP).
- Trial name
- MACS1428 (NCT01227577)
- Testing
- Nilotinib
- Where
- 32 sites in United States
- Volunteers
- 128 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase.
- Trial name
- NCT00333840
- Testing
- imatinib mesilate, interferon-alpha (INF-a), cytarabine (ARA-C)
- Where
- 163 sites in United States, Australia and 14 more
- Volunteers
- 1,106 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST)
Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the…
- Conditions
- Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Acute Lymphoblastic Leukemia (ALL), Receptor Tyrosine Kinase (KIT) Mutated Melanoma
- Trial name
- NCT01735955
- Testing
- Nilotinib
- Where
- 33 sites in United States, Austria and 14 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals