A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
- Each treatment cycle lasts four weeks during which time the participant will be taking
study drug for the first three weeks only. Participants will be supplied with a study
medication-dosing calendar for each treatment cycle.
- Clofarabine is a tablet that will be taken orally in the morning once daily on days 1
through 21 of each 28-day cycle. Participants can receive up to a total of 6 cycles if
they do not experience any unacceptable side effects and if their cancer does not get
- The following tests and procedures will be performed at specified intervals through out
the treatment period: blood tests, physical examinations, vital signs, radiological
exams and urine tests.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase II: Determine the efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma using overall response rate (complete and partial).
Jeremy Abramson, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|