Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03534180
Phase
PHASE2
Status
Completed

Conditions

  • Anaplastic Large Cell Lymphoma
  • Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Romidepsin — DRUG
    Given IV
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II trial studies the side effects and best dose of venetoclax and romidepsin to see how well it works in treating patients with mature T-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Aug 21, 2018
Status verified
Oct 2023
Primary completion
Apr 21, 2021
Completion
Jul 26, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, romidepsin)
    Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients With Grade 3 or Above Toxicities [ Time Frame: Up to 30 days post-treatment, an average of 4 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAUniversity of Nebraska Medical Center· Omaha, NE

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