Clinical trials: CML Chronic Phase
Chronic Myeloid Leukemia
Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation)
Rationale: DCC-2036 is a potent broad spectrum inhibitor of BCR-ABL kinase. Inhibition of BCR-ABL has been validated for effective treatment of chronic myeloid leukemia (CML).
- Trial name
- NCT00827138
- Testing
- DCC-2036
- Where
- 10 sites in United States
- Volunteers
- 57 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
Chronic Myelogenous Leukemia
TGRX-678 US Phase I for Chronic Myelogenous Leukemia Patients
The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had…
- Trial name
- NCT06088888
- Testing
- TGRX-678
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Shenzhen TargetRx Co., Ltd.
Chronic Myelogenous Leukemia
Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.
- Trial name
- NCT00081926
- Testing
- Gleevec
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia in Chronic Phase
RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
This is a non-interventional, prospective, observational single arm study describing the real-world effectiveness, tolerability, adherence, Healthcare Resource Utilization (HCRU) and Patient-Reported Outcome (PRO) data of…
- Trial name
- ASC4REAL (NCT06684964)
- Testing
- asciminib
- Where
- 4 sites in Saudi Arabia
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia
- Trial name
- NCT01297543
- Testing
- human myeloid progenitor cells, G-CSF
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Cellerant Therapeutics
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.
CML, Chronic Phase
Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.
- Trial name
- ICT10 (NCT02949570)
- Testing
- Inecalcitol
- Where
- France
- Volunteers
- 54 people
- Sponsor
- Hybrigenics Corporation
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
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
Leukemia, Myeloid, Chronic Phase
Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.
- Trial name
- TOPS (NCT00124748)
- Testing
- Imatinib mesylate
- Where
- 75 sites in United States, Argentina and 4 more
- Volunteers
- 476 people
- Sponsor
- Novartis Pharmaceuticals
Myeloid Leukemia, Chronic, Myeloid Leukemia, Chronic, Accelerated-Phase
Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate).
- Conditions
- Myeloid Leukemia, Chronic, Myeloid Leukemia, Chronic, Accelerated-Phase, Blast Phase, Myeloid Leukemia, Chronic, Chronic-Phase
- Trial name
- NCT00114959
- Testing
- Homoharringtonine, Imatinib Mesylate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- ChemGenex 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
Leukemia, Myeloid, Chronic-Phase
A Study of Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia Patients in Kuwait
The aim of this study is to assess demographics, clinical features, treatment patterns, and the comorbidity burden and its impact on CML patients in the real-world clinical setting in Kuwait.
- Trial name
- NCT07454850
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
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
Hematological Malignancy, Leukemia
A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy
The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor…
- Conditions
- Hematological Malignancy, Leukemia, Lymphoma, Multiple Myeloma
- Trial name
- NCT00558675
- Testing
- AlloStim
- Where
- Israel
- Volunteers
- 6 people
- Sponsor
- Mirror Biologics, Inc.
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.
Chronic Myeloid Leukemia
To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib
This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients.
- Trial name
- NCT01223898
- Testing
- Tasigna
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals