Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell.
The phase I component of this research study is complete and demonstrated encouraging safety and efficacy in low-grade B-cell lymphomas. The phase II component of the trial is accruing to further study the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
Marginal Zone Lymphoma
Mantle Cell Lymphoma
Small Lymphocytic Lymphoma
Low Grade B-cell Lymphoma, Not Otherwise Specified
Diffuse Large B-cell Lymphoma
Peripheral T-cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Anaplastic Large-cell Lymphoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma|
- Phase II: Determine the efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma using overall response rate (complete and partial). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Phase I: To determine the MTD and efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Phase II: Determine the duration of response, progression-free survival and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- 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 worse.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644189
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jeremy Abramson, MD||Massachusetts General Hospital|