A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

NCT01744665 | Completed Phase 2 Results

• 1 other identifier: CAMN107AUS37
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 54

Brief Summary

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

Conditions

CML

Keywords

CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase

  Percentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels \>0.1% IS taken approximately 4 weeks apart).

  6 months after stopping nilotinib therapy

Secondary Outcomes (13)

• Relapse Free Survival is Defined as Time From the Date of Nilotinib Treatment Discontinuation to the First Documented Molecular Relapse (Confirmed Loss of MR4.5).

  7 years

• Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase

  12 and 24 months after starting the TFR

• Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse

  Restart of nilotinib up to month 6, 12 and 24

• Number of Participants Who Progressed to Accelerated Phase/Blastic Crisis (AP/BC) or Died From From Any Cause.

  Baseline up to approximately 5 years

• Overall Survival (OS)

  Baseline up to approximately 5 years

Study Arms (1)

Treatment Free Remission

EXPERIMENTAL

Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.

Drug: nilotinib

Interventions

nilotinib DRUG

Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.

Also known as: AMN107

Treatment Free Remission

Eligibility Criteria

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

You may qualify if:

• diagnosis of CML
• Treated with at least 1 year of imatinib
• Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening
• Written informed consent obtained prior to any screening procedures performed

You may not qualify if:

• T315I mutation
• Prior imatinib failure or had accelerated phase or blast crisis CML
• Impaired cardiac function
• Pregnant or lactating women

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (54)

University of Alabama Comprehensive Cancer Center University of Alabama (8)

Birmingham, Alabama, 35294, United States

Location

Banner MD Anderson Cancer Center Banner MD Anderson (2)

Gilbert, Arizona, 85234, United States

Location

Scottsdale Healthcare/TGen Clinical Research Service SC

Scottsdale, Arizona, 85258, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

City of Hope National Medical Center Dept of Oncology

Duarte, California, 91010 3000, United States

Location

Compassionate Care Research Group Inc CCCMG

Fountain Valley, California, 92708, United States

Location

UC San Diego UC San Diego Cancer Ctr

La Jolla, California, 92093-0987, United States

Location

Wilshire Oncology Medical Group Corona Cancer Center

Multiple Locations, California, United States

Location

Epic-Care

Pleasant Hill, California, 94523, United States

Location

Sutter Institute for Medical Research Oncology/Hematology

Sacramento, California, 95816-5199, United States

Location

St Joseph Heritage Healthcare

Santa Rosa, California, 94503, United States

Location

Rocky Mountain Cancer Centers USOR

Boulder, Colorado, 80304, United States

Location

Florida Cancer Specialists DeptofFloridaCancerSpecialists

Fort Myers, Florida, 33901, United States

Location

MD Anderson Cancer Center - Orlando Cancer Center

Orlando, Florida, 32806, United States

Location

H Lee Moffitt Cancer Center and Research Institute H. Lee Moffitt Cancer Ctr (67)

Tampa, Florida, 33612, United States

Location

Stroger Cook County Hospital Division of Hematology & Onc

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Ct

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital and Medical Center Clinical Research Center

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214-3728, United States

Location

Christus Schumpert Health System

Shreveport, Louisiana, 71101, United States

Location

Michigan State University / Breslin Cancer Center Breslin Cancer Center (3)

Lansing, Michigan, United States

Location

Billings Clinic Billings Clinic (8)

Billings Montana, Montana, 59101, United States

Location

Hackensack University Medical Center John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJ

Morristown, New Jersey, 07962, United States

Location

Memorial Sloan Kettering Memorial Sloan Kettering (63)

New York, New York, 10017, United States

Location

Weill Cornell Medical Center Dept. of Oncology

New York, New York, 10021, United States

Location

Columbia University Medical Center Herbert Irving Pavilion

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center Montefiore Medicial Center

The Bronx, New York, 10467, United States

Location

Westchester Medical Center NY Medical College

Valhalla, New York, 10595, United States

Location

Duke University Medical Center Duke University Med Ctr

Durham, North Carolina, 27710, United States

Location

Carolina Oncology Specialists, PC

Hickory, North Carolina, 28602, United States

Location

Wake Forest University Health Sciences Hematology and Oncology

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State Comprehensive Cancer Center/James Cancer Hospital OSU Medical Center

Columbus, Ohio, 43210, United States

Location

Northwest Cancer Specialists Compass Oncology -BKM

Portland, Oregon, 97210, United States

Location

University of South Carolina-Hollings Cancer Center Medical University of SC

Columbia, South Carolina, 29203, United States

Location

Tennessee Oncology Dept. of Centennial Medical

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Univeristy Ingram Cancer Center (10)

Nashville, Tennessee, 37232, United States

Location

Hendrick Cancer Center Hendricks Cancer Center

Abilene, Texas, 79601, United States

Location

Texas Oncology Texas Oncology - McAllen

Dallas, Texas, 75246, United States

Location

Texas Oncology Texas Oncology - Plano West

Dallas, Texas, 75246, United States

Location

Texas Oncology P A Texas Oncology - Midland

Dallas, Texas, 75251, United States

Location

University of Texas Medical Branch SC

Galveston, Texas, 77555-1188, United States

Location

Oncology Consultants Oncology Consultants, P.A.

Houston, Texas, 77024, United States

Location

The Methodist Hospital Cornell University

Houston, Texas, 77030, United States

Location

South Texas Cancer Center- McAllen

McAllen, Texas, 78503, United States

Location

Brooke Army Medical Center Brooke Army Medical

San Antonio, Texas, 78234, United States

Location

Waco Cancer and Research Center

Waco, Texas, 76712, United States

Location

University of Utah / Huntsman Cancer Institute Huntsman Cancer Center

Salt Lake City, Utah, 84103, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Kadlec Clinic Hematology and Oncology SC

Kennewick, Washington, 99336, United States

Location

West Virginia University/ Mary Babb Randolph Cancer Center Mary Babb Randolph Cancer Ctr

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin Med College of WI

Milwaukee, Wisconsin, 53226, 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: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

888-669-6682

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 7, 2012
• Study Start: August 12, 2013
• Primary Completion: September 28, 2018
• Study Completion: September 29, 2018
• Last Updated: March 10, 2020
• Results First Posted: March 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (54)