Chronic Phase CML Clinical Trial
Official title:
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
NCT number | NCT01490775 |
Other study ID # | CAMN107AUS12T |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2009 |
Est. completion date | June 30, 2015 |
Verified date | April 2017 |
Source | Rex Cancer Center, Raleigh, NC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.
Status | Terminated |
Enrollment | 27 |
Est. completion date | June 30, 2015 |
Est. primary completion date | February 12, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients 18 years of age or older. - Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate - Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily - Known performance status 0,1 or 2 (ECOG) - Known adequate end organ function, defined as: Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN ANC > 1.5 Platlets > 100,000 - Patient is willing and able to use a cell phone - Written, voluntary informed consent Exclusion Criteria: - Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
United States | Rex Cancer Center - Wakefield | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Rex Cancer Center, Raleigh, NC | Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | eMedonline will be used to measure non-compliance in taking oral drug regimens. | Patients are stratified to one of two groups: Group 1 is pateints on Gleevec or Tasigna who have been on drug less than 6 months; Group 2 is patients on Gleevec or Tasigna who have been on drug for equal to or more than 6 months. Group 1 is then divided into 2 groups: one using eMedonline for 3 months and the other not using eMedonline for 3 months. A crossover survey and pill counts will be done at the 3 month timepoint and then the groups will switch their access status to eMedonline. |
at 6 months, non-compliance will be measured in each arm of study |