ClinicalTrials.gg
RecruitingNCT03838926Updated Mar 16, 2026

Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies

A Phase 1 interventional study of Trichostatin A in Relapsed or Refractory Hematologic Malignancies, sponsored by Vanda Pharmaceuticals. Recruiting at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.

Primary conditionHematologic NeoplasmsRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hematologic Neoplasms
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Hematologic Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Vanda Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2018, registered Feb 2019).
  • Started Sep 2018; still recruiting 8 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Relapsed or Refractory Hematologic Malignancies

Browse trials for

Keywords

  • Hematologic
  • Malignancies
  • Cancer
  • Blood
03

In context

Hematologic Neoplasms Reclassified

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

This study's planned enrollment of 42 is close to the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.

Compared within Hematologic Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is ≥ 18 years at the time of signing ;
  • Confirmed malignant hematologic disease or lymphoid that has or is refractory to standard therapy and has exhausted all available therapies;
  • Presence of measurable or evaluable disease;
  • (ECOG) performance status of ≤ 2;
  • or other approved avoidance of pregnancy measures

Exclusion criteria

Exclusion Criteria:

  • stem cell transplant recipient presenting with (GVHD) either active or requiring ;
  • 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
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Trichostatin A

    Drug: Trichostatin A

Interventions

  • DrugTrichostatin A

    Intravenous Infusion

06

What researchers measure

Primary outcomes

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

    Measured by spontaneous reporting of adverse events (AEs)

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

07

Study locations

4 of 11 sites recruiting
  • Vanda Investigational Site
    Washington D.C., District of Columbia 20007, United States
    Withdrawn

    Not enrolling at this site.

  • Vanda Investigational Site
    Lafayette, Indiana 47905, United States
    Completed

    Not enrolling at this site.

  • Vanda Investigational Site
    Hackensack, New Jersey 07601, United States
    Withdrawn

    Not enrolling at this site.

  • Vanda Investigational Site
    Seattle, Washington 98109, United States
    Completed

    Not enrolling at this site.

  • Vanda Investigational Site
    Biała Podlaska, Poland
    Recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    Katowice, Poland
    Recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    Krakow, Poland
    Completed

    Not enrolling at this site.

  • Vanda Investigational Site
    Opole, Poland
    Recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    Skorzewo, Poland
    Completed

    Not enrolling at this site.

  • Vanda Investigational Site
    Warsaw, Poland
    Recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    Wroclaw, Poland
    Completed

    Not enrolling at this site.

08

References and documents

Publications

  • Dhingra N, Gupta V, Tyagi A, Agrawala PK, Gupta V. Trichostatin A ameliorated combined radiation and skin wound injury-induced mortality and hematopoietic suppression in a rat model. Int J Radiat Biol. 2025;101(9):952-972. doi: 10.1080/09553002.2025.2537211. Epub 2025 Aug 4. PubMed 40758573 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03838926
Responsible party
Sponsor
First posted
Feb 12, 2019
Start date
Sep 27, 2018
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 16, 2026

Study contacts

Vanda Pharmaceuticals
Contact
clinicaltrials@vandapharma.com
202-734-3400

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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