Actively Recruiting
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Led by Vanda Pharmaceuticals · Updated on 2026-03-16
42
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of trichostatin A in adults with relapsed or refractory blood cancers who have exhausted all standard treatment options. This Phase 1 study focuses on assessing the side effects and determining the maximum dose of trichostatin A that can be tolerated by participants. The study is sponsored by Vanda Pharmaceuticals and targets individuals with measurable or evaluable disease and a performance status allowing participation. Participants will receive trichostatin A administered through intravenous infusion. The study monitors participants over a period of up to 24 months to collect data on adverse events and dose-limiting toxicities. There is no masking or placebo control, and all participants receive the experimental drug. During the study, participants will be closely observed for side effects and tolerability through spontaneous adverse event reporting. Researchers will measure the safety outcomes and maximum tolerated dose throughout the study duration. Participants must be available for monitoring and follow-up visits as required by the trial protocol until the study ends in December 2027.
CONDITIONS
Brief Title
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years or older at the time of signing informed consent
- Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies
- Presence of measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Use of contraceptives or other approved pregnancy avoidance measures
You will not qualify if you...
- Allogeneic stem cell transplant recipient with active graft versus host disease (GVHD) or requiring immunosuppression
- Receiving other anti-cancer therapy (bisphosphonates allowed)
- Major surgery within 2 weeks prior to starting study drug
- Evidence of mucosal or internal bleeding
- Impaired heart function or conduction defects
- Concurrent severe or uncontrolled medical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive intravenous infusions of Trichostatin A to assess safety and tolerability.
Trial Site Locations
Total: 11 locations
1
Vanda Investigational Site
Washington D.C., District of Columbia, United States, 20007
Withdrawn
2
Vanda Investigational Site
Lafayette, Indiana, United States, 47905
Completed
3
Vanda Investigational Site
Hackensack, New Jersey, United States, 07601
Withdrawn
4
Vanda Investigational Site
Seattle, Washington, United States, 98109
Completed
5
Vanda Investigational Site
Biała Podlaska, Poland
Actively Recruiting
6
Vanda Investigational Site
Katowice, Poland
Actively Recruiting
7
Vanda Investigational Site
Krakow, Poland
Completed
8
Vanda Investigational Site
Opole, Poland
Actively Recruiting
9
Vanda Investigational Site
Skorzewo, Poland
Completed
10
Vanda Investigational Site
Warsaw, Poland
Actively Recruiting
11
Vanda Investigational Site
Wroclaw, Poland
Completed
Research Team
V
Vanda Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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