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Romidepsin and Brentuximab Vedotin in Treating Patients with Cutaneous T-Cell Lymphoma

Trial Status: Active

This phase I trial studies the best dose and side effects of romidepsin when given together with brentuximab vedotin in treating patients with cutaneous T-cell lymphoma. Romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Giving romidepsin and brentuximab vedotin together may work better in treating patients with cutaneous T-cell lymphoma.

Inclusion Criteria

  • 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 anaplastic large cell lymphoma (ALCL) (pc-ALCL) as defined by the World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissue
  • Please note that tumor samples for patients with MF or SS can be CD30 negative and do not have to be CD30 positive on either flow cytometry or immunohistochemistry for patients to be eligible
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGOT]/serum glutamate pyruvate transaminase [SGPT]) =< 2 times institutional normal limits
  • Creatinine within normal institutional limits OR
  • Creatinine clearance >= 60 Ml/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test
  • Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
  • Patients with human immunodeficiency virus (HIV) who are not receiving cytochrome p450 inhibitors, and who have a minimum of 300+ CD4+ cells/mm^3, an undetectable viral load, and no history of acquired immunodeficiency syndrome (AIDS) indicator conditions

Exclusion Criteria

  • 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 central nervous system (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 histone deacetylase (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
  • Pregnant or breast feeding
  • Second malignancies that require active treatment with the exception of non-melanomatous skin cancers, and/or breast or prostate cancer on endocrine therapy

New Jersey

Hackensack University Medical Center
Status: ACTIVE
Contact: Tatyana A. Feldman


Fox Chase Cancer Center
Status: ACTIVE
Contact: Nadia Khan
Phone: 215-728-2674
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Stefan Klaus Barta


I. To identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of the combination of brentuximab vedotin and romidepsin for patients with cutaneous T-cell lymphoma (CTCL).


I. To assess the overall safety and tolerability of the combination of brentuximab vedotin (BV) & romidepsin.

II. To estimate the response rate (rate of complete and partial response; overall response rate [ORR = complete response (CR) + partial response (PR)]) of the combination treatment.

III. To estimate duration of response.

IV. To assess changes quality of life using the Skindex-16 questionnaire.

V. To estimate patient survival for the combination treatment.


I. To assess the association of CD30 expression and treatment response.

II. To assess changes in CD30 expression after 1 dose of romidepsin treatment.

III. To assess biomarkers for treatment response using Nanostring.

OUTLINE: This is a dose-escalation study of romidepsin.

Patients receive romidepsin intravenously (IV) over 4 hours on day -14. Beginning in cycle 1, patients receive romidepsin IV over 4 hours on days 1 and 15 or days 1, 8, and 15, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and every 12 weeks for 2 years.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Fox Chase Cancer Center

Principal Investigator
Nadia Khan

  • Primary ID HM-085
  • Secondary IDs NCI-2017-01010
  • ID NCT02616965