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

NCT ID: NCT03838926

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Relapsed or Refractory Hematologic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trichostatin A

Group Type EXPERIMENTAL

Trichostatin A

Intervention Type DRUG

Intravenous Infusion

Interventions

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Trichostatin A

Intravenous Infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

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

Site Status WITHDRAWN

Vanda Investigational Site

Lafayette, Indiana, United States

Site Status COMPLETED

Vanda Investigational Site

Hackensack, New Jersey, United States

Site Status WITHDRAWN

Vanda Investigational Site

Seattle, Washington, United States

Site Status COMPLETED

Vanda Investigational Site

Biała Podlaska, , Poland

Site Status RECRUITING

Vanda Investigational Site

Katowice, , Poland

Site Status RECRUITING

Vanda Investigational Site

Krakow, , Poland

Site Status RECRUITING

Vanda Investigational Site

Opole, , Poland

Site Status RECRUITING

Vanda Investigational Site

Skorzewo, , Poland

Site Status RECRUITING

Vanda Investigational Site

Warsaw, , Poland

Site Status RECRUITING

Vanda Investigational Site

Wroclaw, , Poland

Site Status RECRUITING

Countries

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United States Poland

Central Contacts

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Vanda Pharmaceuticals

Role: CONTACT

202-734-3400

Facility Contacts

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Vanda Pharmaceuticals

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Other Identifiers

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VP-VTR-297-1101

Identifier Type: -

Identifier Source: org_study_id

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