Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
NCT00769327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129
Last updated 2022-01-04
Summary
RATIONALE: Nilotinib and imatinib mesylate 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 giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.
Conditions
Interventions
- DRUG
-
imatinib mesylate
- DRUG
-
nilotinib
- GENETIC
-
cytogenetic analysis
- GENETIC
-
fluorescence in situ hybridization
- GENETIC
-
microarray analysis
- GENETIC
-
mutation analysis
- GENETIC
-
polymerase chain reaction
- GENETIC
-
polymorphism analysis
- OTHER
-
laboratory biomarker analysis
Sponsors & Collaborators
-
Gruppo Italiano Malattie EMatologiche dell'Adulto
lead OTHER
Principal Investigators
-
Michele Baccarani, MD · Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-02-09
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-10
Countries
- Italy
Study Locations
More Related Trials
-
Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib
NCT00644878 ·Status: TERMINATED ·Phase: PHASE2
-
Myeloid Derived Suppressor Cells and Chronic Myeloid Leukemia
NCT03214718 ·Status: UNKNOWN ·Phase: NA
-
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
NCT02272777 ·Status: COMPLETED ·Phase: PHASE3
-
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
NCT02709083 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
NCT00786812 ·Status: COMPLETED ·Phase: PHASE4
-
Nilotinib in PH+, BCR-, ABL+ CML Patients
NCT01535391 ·Status: COMPLETED ·Phase: PHASE3
-
TyrosIne Kinase Inhibitors in Chronic Myeloid Leukemia: Efficacy and Tolerability. The TIKlet Study
NCT01860456 ·Status: COMPLETED
-
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
NCT03578367 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant
NCT00413270 ·Status: NO_LONGER_AVAILABLE
-
Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)
NCT01279473 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response
NCT01043874 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
NCT00130195 ·Status: COMPLETED ·Phase: PHASE2
-
Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
NCT00702403 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
NCT00219752 ·Status: COMPLETED ·Phase: PHASE2
-
Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.
NCT01605981 ·Status: WITHDRAWN ·Phase: PHASE4
-
A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia
NCT02627677 ·Status: TERMINATED ·Phase: PHASE3
-
Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
NCT00028847 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib
NCT02733445 ·Status: COMPLETED
-
Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
NCT00809211 ·Status: COMPLETED ·Phase: PHASE2
-
Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
NCT01061177 ·Status: COMPLETED ·Phase: PHASE4
-
An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years
NCT02174445 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
NCT01131325 ·Status: TERMINATED ·Phase: PHASE4
-
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
NCT03228303 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
NCT00237120 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)
NCT00129740 ·Status: COMPLETED ·Phase: PHASE2