Relapsed or Refractory Hematologic MalignanciesPhase 1NCT03838926
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study testing Trichostatin A in people with Relapsed or Refractory Hematologic Malignancies, run by Vanda Pharmaceuticals at 11 sites in 2 countries.
Trial summary
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Hematologic Malignancies
- What is being tested?
- Trichostatin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 27 Sep 2018to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
Poland7 sites, 4 recruiting
- Recruiting
Vanda Investigational Site
Biała Podlaska
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Katowice
Vanda Pharmaceuticals, 202-734-3400
- Completed
Vanda Investigational Site
Krakow
- Recruiting
Vanda Investigational Site
Opole
Vanda Pharmaceuticals, 202-734-3400
- Completed
Vanda Investigational Site
Skorzewo
- Recruiting
Vanda Investigational Site
Warsaw
Vanda Pharmaceuticals, 202-734-3400
- Completed
Vanda Investigational Site
Wroclaw
United States4 sites
- Withdrawn
Vanda Investigational Site
Hackensack, New Jersey, 07601
- Completed
Vanda Investigational Site
Lafayette, Indiana, 47905
- Completed
Vanda Investigational Site
Seattle, Washington, 98109
- Withdrawn
Vanda Investigational Site
Washington D.C., District of Columbia, 20007
About this study
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.
- Being tested
- Trichostatin A
- Keywords
- Hematologic, Malignancies, Cancer, Blood
- Medical subject headings
- Recurrence, Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichostatin ADrug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Trichostatin A | Experimental | Not described Receives: Drug: Trichostatin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
Measured by spontaneous reporting of adverse events (AEs)
Measured: Up to 24 months
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start27 Sep 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838926
- Sponsor's protocol ID
- VP-VTR-297-1101
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2019
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT03838926
- Acronym / sponsor ID
- VP-VTR-297-1101
- Keywords
- Hematologic, Malignancies, Cancer, Blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichostatin A | Experimental | Drug: Trichostatin A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trichostatin AIntravenous Infusion | Drug | Trichostatin A |
Primary outcome
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
Time frame: Up to 24 months
Measured by spontaneous reporting of adverse events (AEs)
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 40758573Dhingra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trichostatin A in people with Relapsed or Refractory Hematologic Malignancies, run by Vanda Pharmaceuticals at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03838926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.