Clinical trials: CML - Philadelphia Chromosome
Leukemia
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
- Trial name
- NCT01357655
- Testing
- Dasatinib, BMS-833923
- Where
- 24 sites in United States, Argentina and 6 more
- Volunteers
- 70 people
- Sponsor
- Bristol-Myers Squibb
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase…
- Trial name
- NCT00171223
- Testing
- STI571
- Where
- 28 sites in United States, France and 4 more
- Volunteers
- 532 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
Leukemia
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per…
- Trial name
- NCT02272777
- Testing
- Imatinib, Nilotinib
- Where
- 12 sites in China
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Acute Lymphoblastic Leukemia, BCR-ABL1 Fusion Protein Expression
Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.
This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia.
- Conditions
- Acute Lymphoblastic Leukemia, BCR-ABL1 Fusion Protein Expression, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive
- Trial name
- NCT00390793
- Testing
- Cyclophosphamide, Cytarabine, Dasatinib
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
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 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
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult…
- Trial name
- NCT01077544
- Testing
- Nilotinib
- Where
- 12 sites in France, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
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
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 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
Myeloid Leukemia, Chronic
A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice…
- Trial name
- NCT00482703
- Testing
- Dasatinib
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Chronic Myelogenous Leukemia
Study Evaluating SKI-606 (Bosutinib) In Japanese Subjects With Philadelphia Chromosome Positive Leukemias
This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an escalating dose of SKI-606 (Bosutinib), up to 600…
- Trial name
- NCT00811070
- Testing
- SKI-606 (Bosutinib)
- Where
- 23 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Pfizer
Chronic Myeloid Leukemia
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML).
- Trial name
- NCT00574873
- Testing
- Bosutinib, imatinib
- Where
- 165 sites in United States, Argentina and 27 more
- Volunteers
- 502 people
- Sponsor
- Pfizer
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
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
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive
Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
This phase I/II trial studies the best dose of venetoclax when given together with ponatinib and dexamethasone and to see how well they work in treating participants with Philadelphia chromosome or BCR-ABL positive acute…
- Conditions
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, Recurrent Acute Lymphoblastic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Trial name
- NCT03576547
- Testing
- Dexamethasone, Ponatinib Hydrochloride, Rituximab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- M.D. Anderson Cancer Center