Clinical trials: CML - Philadelphia Chromosome
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with…
- Trial name
- ASC4START (NCT05456191)
- Testing
- Asciminib, Nilotinib
- Where
- 119 sites in United States, Argentina and 22 more
- Volunteers
- 568 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.
Chronic Myelogenous Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)(0457-009)(TERMINATED)
This study will evaluate MK0457 in combination with Dasatinib in patients with Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Efficacy and Safety will be evaluated.
- Trial name
- NCT00500006
- Testing
- MK0457, dasatinib
- Volunteers
- 3 people
- Sponsor
- Merck Sharp & Dohme LLC
Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.
- Trial name
- NCT02130557
- Testing
- Bosutinib, Imatinib
- Where
- 189 sites in United States, Australia and 24 more
- Volunteers
- 536 people
- Sponsor
- Pfizer
Leukemia, Myeloid, Chronic, Leukemia, Lymphocytic, Acute, L2
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer…
- Trial name
- NCT00298987
- Testing
- Dasatinib
- Where
- 35 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Bristol-Myers Squibb
Philadelphia Chromosome Positive CML
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis
This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.
- Trial name
- NCT00171158
- Testing
- imatinib mesylate
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 260 people
- Sponsor
- Novartis Pharmaceuticals
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
Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML), Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)
Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)
This study will evaluate a gene expression signature (Growth Factor Signature [GFS]) as a biomarker for response/resistance to BRC-ABL oncogene inhibitors.
- Trial name
- NCT00860535
- Testing
- Comparator: Biomarker evaluation
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Myeloid Leukemia, Chronic Phase, CML, Chronic Phase
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be…
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase, CML, Chronic Phase, CML, Refractory, CML - Philadelphia Chromosome
- Trial name
- NCT03459534
- Testing
- Radotinib HCl
- Where
- 18 sites in Russia, South Korea and 2 more
- Volunteers
- 173 people
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Myeloid Leukemia, Chronic, Chronic-Phase
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
- Trial name
- NCT00123474
- Testing
- dasatinib
- Where
- 137 sites in United States, Argentina and 29 more
- Volunteers
- 724 people
- Sponsor
- Bristol-Myers Squibb
Chronic Myeloid Leukemia
Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)
This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
- Trial name
- NICOLI (NCT01220648)
- Testing
- Nilotinib, interferon-alfa
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with…
- Trial name
- NCT00103844
- Testing
- Dasatinib, Imatinib
- Where
- 131 sites in United States, Argentina and 30 more
- Volunteers
- 150 people
- Sponsor
- Bristol-Myers Squibb
Chronic Myeloid Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety, pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult patients with Philadelphia chromosome positive…
- Trial name
- NCT02885766
- Testing
- PF-114
- Where
- 3 sites in Russia
- Volunteers
- 65 people
- Sponsor
- Fusion Pharma LLC
Leukemia, Leukemia, Myeloid
Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI
A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase inhibitors (Imatinib and/ or Dasatinib, Nilotinib)…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome
- Trial name
- NCT01602952
- Testing
- Radotinib
- Where
- 12 sites in India, South Korea and 1 more
- Volunteers
- 85 people
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate…
- Trial name
- NCT01374139
- Testing
- Bosutinib
- Where
- Singapore
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified release tablet, MR2 compared to…
- Trial name
- NCT00422825
- Testing
- imatinib
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic…
- Trial name
- NCT02081378
- Testing
- Asciminib (ABL001), Nilotinib, Imatinib
- Where
- 18 sites in United States, Australia and 8 more
- Volunteers
- 326 people
- Sponsor
- Novartis Pharmaceuticals
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
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome…
- Trial name
- NCT00349518
- Testing
- Dasatinib
- Where
- 20 sites in Hungary, Italy and 4 more
- Sponsor
- Bristol-Myers Squibb
Leukemia
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients.
- Trial name
- NCT00362466
- Testing
- Dasatinib, Imatinib
- Where
- 45 sites in United States
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb