Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

Stopped early · Not applicable

Conditions studied: Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01490983

Run by

Rex Cancer Center, Raleigh, NC

People needed

14

Starts

2009-04-01

Expected to finish

2014-12-01

Last updated by the study team

2018-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• ECOG Performance status 0, 1, or 2
• Adequate end organ function, defined as:
• Total bilirubin < 1.5 xULN
• SGOT and SGPT <2.5 x ULN
• Creatinine < 1.5 x ULN
• ANC > 1.5
• Platelets > 100,000
• Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening.
• Patient is able to read and speak English
• Patient is willing and able to use a cell phone
• Written, voluntary informed consent

You may not qualify if…

• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Where it is running

• UNC Healthcare — Chapel Hill, North Carolina, United States
• Rex Cancer Center — Raleigh, North Carolina, United States
• Rex Cancer Center - Wakefield — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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