Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Nilotinib 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 nilotinib works in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.


Clinical Trial Description

OBJECTIVES:

Primary

- To establish the complete cytogenetic response rate at 6 months in patients with newly diagnosed Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with nilotinib.

Secondary

- To establish the complete cytogenetic response rate at 3, 9, 12, 18, and 24 months in these patients.

- To establish the molecular response rate at 3, 6, 9, 12, 18, and 24 months in these patients.

- To establish the safety of this drug in these patients.

- To correlate pharmacokinetic data with response rate and toxicity.

- To correlate Bcr-Abl results using GeneXpert with Bcr-Abl results using international standardized quantitative PCR.

- To estimate the prevalence of Bcr-Abl mutations prior to and during treatment.

OUTLINE: This is a multicenter study.

Patients receive oral nilotinib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for mutation analysis, Bcr-Abl analysis by quantitative PCR, metaphase cytogenetics, and pharmacokinetic analysis.

After completion of study therapy, patients are followed every 3 months for 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00809211
Study type Interventional
Source Cancer Trials Ireland
Contact
Status Completed
Phase Phase 2
Start date October 2008
Completion date February 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Recruiting NCT04092803 - Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu N/A
Active, not recruiting NCT02530463 - Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome Phase 2
Completed NCT00948064 - Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Recruiting NCT03948529 - RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation Phase 2
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Active, not recruiting NCT02723994 - A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia Phase 2
Terminated NCT02469415 - Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS) Phase 2
Recruiting NCT04856215 - 90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia Phase 2
Recruiting NCT06155188 - Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia N/A
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Completed NCT02910583 - Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) Phase 2
Completed NCT01212926 - Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain N/A
Terminated NCT00014560 - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A