Lymphoma
A Phase II, Multicenter, Open-Label Trial Evaluating the Activity and Tolerability of Romidepsin (Depsipeptide, FK228) in Progressive or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy
NCI-08-C-0164
Print this page 
Investigator(s): |
Richard Piekarz, M.D., Ph.D.
Principal Investigator
Phone: 301-496-1196
rpiekarz@nih.gov
|
|
|
|
Robin Frye, R.N., B.S.N.
Research Nurse
Phone: 301-402-5958
fryer@mail.nih.gov
|
|
|
| |
Primary Eligibility:
- Histologically confirmed peripheral T-Cell lymphoma (PTCL)
- Progressive disease following at least one systemic therapy or refractory to at least one prior systemic therapy
- ≥ 18 years
- Measurable disease
- ECOG 0-2
- No central nervous system (CNS) lymphoma
- No cardiac abnormalities
- No uncontrolled hypertension, i.e., blood pressure (BP) of ≥ 160/95
- No previous allogeneic stem cell transplant
- Negative for HIV, hepatitis B and hepatitis C
- Adequate bone marrow or other organ function
- Not pregnant or nursing
Study Outline:
This is a Phase II, open-label, non-randomized, single-arm trial.
- Patients will receive romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle
- Study treatment is 6 cycles or until disease progression occurs
- CAT scan of the chest, abdomen, pelvis and/or neck and PET scan will be done after every even cycle of romidepsin (after cycle 2, after cycle 4, etc)
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 10/29/09
Updated: 5/14/09
Back to Top
