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Romidepsin for T-Cell Lymphoma

Name of the Trial

Phase II Study of FR901228 (Depsipeptide) in Patients with Cutaneous T-Cell Lymphoma, Relapsed Peripheral T-Cell Lymphoma, or Other Mature T-Cell Lymphoma (NCI-01-C-0049). See the protocol summary.

Principal Investigators

Dr. Susan E. Bates and Dr. Richard Piekarz, NCI Center for Cancer Research.

Drs. Susan Bates and Richard Piekarz
Drs. Susan Bates and Richard Piekarz
Principal Investigator

Why This Trial Is Important

Principal investigators for this phase II trial, which was first featured in the January 13, 2004, issue of the NCI Cancer Bulletin, are seeking additional patients with cutaneous T-cell lymphoma to form a new study population, or cohort.

"Because of the promising responses we've seen in the first cohort of this study, we've opened a new cohort specifically for patients with cutaneous T-cell lymphoma who have had two or fewer prior chemotherapy regimens," said Dr. Piekarz.

With this trial, researchers are seeking to determine whether romidepsin (FR901228, depsipeptide), a histone deacetylase inhibitor, can help bring about remission in patients with T-cell lymphoma.

"This trial is very exciting because it involves a new class of anticancer drugs that can change the way cells grow," said Dr. Bates. "Whereas many chemotherapy drugs work by causing damage to cells, histone deacetylase inhibitors like romidepsin turn on genes in cancer cells that inhibit cell growth and eventually cause the cancer cells to die."

"We are continuing to see a complete or partial response rate between 30 and 40 percent for patients with cutaneous T-cell lymphoma," Dr. Piekarz said. "And the response rate for patients with peripheral T-cell lymphoma has remained steady at 25 percent."

For More Information

This study is no longer accepting patients. To locate other clinical trials for lymphoma, search the NCI list of clinical trials or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937). The call is toll free and completely confidential.

  • Posted: January 13, 2004
  • Updated: May 1, 2007