NCT03838926

Brief Summary

The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
19mo left

Started Sep 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Sep 2018Dec 2027

Study Start

First participant enrolled

September 27, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

9.2 years

First QC Date

February 11, 2019

Last Update Submit

March 12, 2026

Conditions

Relapsed or Refractory Hematologic Malignancies

Keywords

HematologicMalignanciesCancerBlood

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)

    Measured by spontaneous reporting of adverse events (AEs)

    Up to 24 months

  • Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A

    Up to 24 months

Study Arms (1)

Trichostatin A

EXPERIMENTAL
Drug: Trichostatin A

Interventions

Trichostatin ADRUG

Intravenous Infusion

Trichostatin A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is ≥ 18 years 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 ≤ 2;
  • Contraceptives or other approved avoidance of pregnancy measures

You may not qualify if:

  • Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;
  • Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);
  • Undergone major surgery ≤ 2 weeks prior to starting study drug;
  • Evidence of mucosal or internal bleeding;
  • Impaired cardiac function or conduction defect;
  • Concurrent severe and/or uncontrolled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Vanda Investigational Site

Washington D.C., District of Columbia, 20007, United States

WITHDRAWN

Vanda Investigational Site

Lafayette, Indiana, 47905, United States

COMPLETED

Vanda Investigational Site

Hackensack, New Jersey, 07601, United States

WITHDRAWN

Vanda Investigational Site

Seattle, Washington, 98109, United States

COMPLETED

Vanda Investigational Site

Biała Podlaska, Poland

RECRUITING

Vanda Investigational Site

Katowice, Poland

RECRUITING

Vanda Investigational Site

Krakow, Poland

COMPLETED

Vanda Investigational Site

Opole, Poland

RECRUITING

Vanda Investigational Site

Skorzewo, Poland

COMPLETED

Vanda Investigational Site

Warsaw, Poland

RECRUITING

Vanda Investigational Site

Wroclaw, Poland

COMPLETED

MeSH Terms

Conditions

RecurrenceHematologic NeoplasmsNeoplasms

Interventions

trichostatin A

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Vanda Pharmaceuticals

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

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

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 12, 2019

Study Start

September 27, 2018

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

PL(7)US(4)