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

NCT02616965 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: HM-08516-1009
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma.

Conditions

Cutaneous T-cell Lymphoma (CTCL)

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  CTCAE v4.03

  during treatment period which is an average of 64 weeks.

• Dose-limiting toxicities (DLTs)

  CTCAE v4.03

  during the first 28 days (cycle 1) of treatment

Secondary Outcomes (5)

• overall safety and tolerability of the combination of brentuximab vedotin & romidepsin assessed by adverse events.

  from start of treatment to 30 days post treatment period (16 cycles)

• Estimate complete and partial response rate of the combination treatment

  64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years

• Estimate complete and partial response rate of the combination treatment

  64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years

• Overall survival (OS)

  From the time of patient registration until death, measured every 12 weeks up to 2 years

• Progression free survival (PFS)

  From the time of patient registration until disease progression, measured every 12 weeks up to 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment consists of the combination of Romidepsin given 10mg/m2 or 14mg/m2 on days 1, 8 and 15 every 28 days and Brentuximab vedotin given 0.9mg/kg or 1.2mg/kg on days 1 and 15 every 28 days for 16 cycles.

Drug: Romidepsin; Drug: Brentuximab vedotin

Interventions

Romidepsin DRUG

Romidepsin at the dosage 10mg/m2 or 14mg/m2 will be given ONCE 14 days prior to cycle one and then on days 1,8,15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles

Treatment

Brentuximab vedotin DRUG

Brentuximab vedotin at the dosage 0.9mg/kg or 1.2 mg/kg will be given on days 1 and 15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 up to 2 lines of systemic treatment. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy.
• Age \> 18 years.
• ECOG performance status 0, 1 or 2.
• Patients must have acceptable organ and marrow function as defined below:
• Absolute neutrophil count \> 1,500/mcL
• Platelets \> 100,000/mcL
• Total bilirubin within normal institutional limits
• AST/ALT (SGOT/SGPT) \< 2 times institutional normal limits
• Creatinine within normal institutional limits OR
• Creatinine clearance \> 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
• Women of child-bearing potential (WOCBP) must have a negative pregnancy test

You may not qualify if:

• 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 except as outlined in 5.2.2
• Patients who have experienced allergic reactions to monoclonal antibodies.
• Patients who have received prior HDAC inhibitors, or brentuximab vedotin, except for patients who were exposed to above drugs only for a short time (less than 8 weeks), did not progress while on treatment, and did not have intolerable toxicity but were discontinued for another reason (e.g., comorbidity) may be permitted to enter the study after discussion with the sponsor-investigator.
• 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. Refer to section 4.4 for further detail.
• Second malignancies that require active treatment with the exception of breast or prostate cancer on endocrine therapy.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Seagen Inc.: collaborator
• Celgene Corporation: collaborator

Study Sites (2)

University of Pennsylvania, Perelman Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

romidepsin; Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Shazia Nakhoda, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 30, 2015
• Study Start: February 22, 2017
• Primary Completion: August 8, 2022
• Study Completion: January 31, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)