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8110 Gatehouse Road, Falls Church, VA 22042

A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma (HM-085)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT02616965

Background Information

The purpose of this research study is to test different doses of the combination of romidepsin and brentuximab vedotin to see which dose is safer in people. The study will also test if the combination of romidepsin and brentuximab vedotin is safe and effective in treating patients with Cutaneous T-cell Lymphoma.

Romidepsin has been approved by FDA for treatment of Cutaneous T-cell Lymphoma.

Brentuximab vedotin has not been FDA approved for treatment of Cutaneous T-cell Lymphoma, but it is approved for certain other types of immune system cancer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults over the age of 18
  • Patients must have histologically or cytologically confirmed diagnosis of mycosis fungoides (MF), Sezary syndrome (SS) or primary cutaneous CD30-positive lymphoproliferative disorder, including lymphomatoid papulosis and primary cutaneous ALCL (pc-ALCL) as defined by the WHO classification of Tumors of Hematopoietic and Lymphoid tissue22
  • Patients with MF/SS must have stage IB, IIA, IIB, III or IV disease; patients with primary cutaneous CD30-positive lymphoproliferative disorder must have multifocal symptomatic or extensive lesions requiring systemic treatment
  • Patients must require systemic treatment
  • Patients can have received any number of systemic treatments prior to participating in this study. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
  • ECOG performance status 0, 1 or 2
  • Patients must have acceptable organ and marrow function
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test
  • Ability to understand and willingness to sign a written informed consent and HIPAA consent document
  • Patients with HIV who are not receiving cytochrome p450 inhibitors, and who have a minimum of 300+ CD4+ cells/mm3, an undetectable viral load, and no history of AIDS indicator conditions
  • Additional eligibility in protocol

Ineligibility Information

  • Patients who have not had resolution of clinically significant toxic effects of prior anticancer therapy to ≤grade 1 as per by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
  • Grade 2 or greater neuropathy
  • Patients may not be receiving any other investigational agents
  • Patients with known CNS involvement • Patients must not receive concurrent systemic or topical steroids or other skin directed therapy while on study
  • Patients who have experienced allergic reactions to monoclonal antibodies
  • Patients who have received prior HDAC inhibitors, or brentuximab vedotin, may be permitted to enter the study unless they have received an HDAC inhibitor or brentuximab within the last 6 months
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Second malignancies that require active treatment with the exception of non-melanomatous skin cancers, and/or breast or prostate cancer on endocrine therapy
  • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT02616965