Trials / Completed
CompletedNCT00644189
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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. This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
Detailed description
* 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.
Conditions
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Mantle Cell Lymphoma
- Small Lymphocytic Lymphoma
- Lymphoplasmacytic 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clofarabine | Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2013-12-01
- Completion
- 2021-07-01
- First posted
- 2008-03-26
- Last updated
- 2023-03-15
- Results posted
- 2017-05-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00644189. Inclusion in this directory is not an endorsement.