Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy

NCT02353728 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1403014950
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an open-label phase 2 clinical and translational trial designed to evaluate the effects of nilotinib on the leukemic stem cell population in subjects with newly diagnosed chronic phase chronic myeloid leukemia (Ph+ CML in CP). Nilotinib is FDA-approved to treat subjects with Ph+ CML in CP. Subjects on study will be monitored according to accepted National Cancer Comprehensive Network \[NCCN\] clinical guidelines for 24 months. After 24 months, if continued therapy is needed subjects will be transitioned to commercial supply of study drug.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Leukemic Stem Cells Present in Bone Marrow Aspirate Samples, in This Patient Population

  The data obtained from these bone marrow samples, from these patients, may identify stem cell variables that can more accurately predict the success of discontinuation of tyrosine kinase inhibitor (TKI) therapy.

  1 month, 3 months, 12 months

Study Arms (1)

All Patients

EXPERIMENTAL

Nilotinib at a dose of 300 mg P.O. twice a day (BID) daily

Drug: Nilotinib

Interventions

Nilotinib DRUG

Also known as: Tasigna, AMN107

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• Eastern Cooperative Oncology Group (ECOG) Performance status 0,1, or 2
• Documented diagnosis of Ph+ Chronic phase CML:
• Chronic phase: None of the criteria for accelerated or blastic phase
• Accelerated phase
• Blasts ≥ 15% in blood or BM
• Blasts plus progranulocytes ≥ 30% in blood or bone marrow (BM)
• Basophilia ≥ 20% in blood or BM
• Platelets \< 100 × 109/L unrelated to therapy
• Cytogenetic clonal evolution
• Blast phase
• ≥ 30% blasts in blood or BM
• Extramedullary disease with localized immature blasts
• Adequate end organ function, defined as the following:
• Creatinine \< 1.5 x upper limit of normal (ULN)

You may not qualify if:

• Previous treatment with any other tyrosine kinase inhibitor except for up to 2 weeks of nilotinib
• Impaired cardiac function including any one of the following:
• Inability to monitor the QT interval on ECG
• Congenital long QT syndrome or a known family history of long QT syndrome.
• Clinically significant resting brachycardia (\<50 beats per minute)
• Q-T Corrected (corrected Q-T interval) (QTc) \> 450 msec on baseline ECG. If QTc \>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
• Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension)
• History of or presence of clinically significant ventricular or atrial tachyarrhythmias
• Complete left bundle branch block
• Right bundle branch block plus left anterior/posterior hemiblock
• Use of ventricular-paced pacemaker
• History of unstable angina within 1 year of study entry
• Patients currently receiving treatment with strong CYP3A4 inhibitors and treatment cannot be either discontinued or switched to a different medication prior to starting study drug. (http://medicine.iupui.edu/clinpharm/ddis/) ).
• Patients currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug (http://crediblemeds.org/)
• Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.Ellen K.Ritchie
• Organization: Weill Cornell Medical College

ritchie@med.cornell.edu

646-962-2700

Study Officials

• Ellen K Ritchie, MD

  Associate Professor of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 25, 2022
• Results First Posted: March 25, 2022

Record last verified: 2022-03

Locations

US (1)