Clinical trials: CML Chronic Phase
Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL)
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute…
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML)
- Trial name
- NCT02730299
- Testing
- NiCord® (omidubicel), Cord Blood Unit
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 125 people
- Sponsor
- Gamida Cell ltd
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
Philidelphia Positive Chronic Myeloid Leukaemia
Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.
The purpose of this Australian study was to assess the efficacy and safety of nilotinib 300mg twice daily in patients with chronic myeloid leukemia chronic phase who were intolerant but responsive to 1st line treatment with…
- Trial name
- ENESTswift (NCT02108951)
- Testing
- Nilotinib
- Where
- 14 sites in Australia
- Volunteers
- 20 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
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
Chronic Myeloid Leukemia, Ph+ Acute Lymphoblastic Leukemia
Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+)…
- Trial name
- PACE (NCT01207440)
- Testing
- Ponatinib
- Where
- 42 sites in Australia, Belgium and 9 more
- Volunteers
- 449 people
- Sponsor
- Ariad Pharmaceuticals
Chronic Myeloid Leukemia
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.
- Trial name
- NCT02011945
- Testing
- Dasatinib, Nivolumab
- Where
- 21 sites in United States, Australia and 5 more
- Volunteers
- 35 people
- Sponsor
- Bristol-Myers Squibb
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
Chronic Myelogenous Leukemia
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of participants with chronic myeloid leukemia - chronic phase (CML-CP) having previously been treated…
- Trial name
- NCT03106779
- Testing
- Asciminib, Bosutinib
- Where
- 88 sites in United States, Argentina and 23 more
- Volunteers
- 233 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL…
- Trial name
- NCT00529763
- Testing
- Dasatinib
- Where
- 14 sites in China
- Volunteers
- 121 people
- Sponsor
- Bristol-Myers Squibb
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 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
Philadelphia Positive Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
The objectives of Part 1 of the study were: To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase…
- Conditions
- Philadelphia Positive Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT00171249
- Testing
- STI571 400 mg, STI571 600 mg
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 293 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.
The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS…
- Trial name
- NILOdeepR (NCT02546674)
- Testing
- Nilotinib
- Where
- 70 sites in Germany
- Volunteers
- 171 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant…
- Trial name
- NCT01030718
- Testing
- dasatinib
- Volunteers
- 54 people
- Sponsor
- Bristol-Myers Squibb
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
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 to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)
To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase 1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary safety and efficacy of omacetaxine following a…
- Trial name
- NCT02078960
- Testing
- Omacetaxine mepesuccinate
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Leukemia
Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)
The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.
- Trial name
- NCT01218477
- Testing
- Dasatinib, BMS-833923
- Where
- 12 sites in United States, Canada and 5 more
- Volunteers
- 33 people
- Sponsor
- Bristol-Myers Squibb
Chronic Myelogenous Leukemia - Chronic Phase
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior…
- Trial name
- AIM4CML (NCT04666259)
- Testing
- ABL001
- Where
- 26 sites in United States
- Volunteers
- 56 people
- Sponsor
- Novartis Pharmaceuticals