Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT01572519

Relapsed or Refractory Hodgkin Lymphoma

COMPLETED PHASE1

phII Study of an HDAC Inhibitor in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients

NCT00496431

Hodgkin's Lymphoma

TERMINATED PHASE1/PHASE2

Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma

NCT00742027

Classical Hodgkin's Lymphoma

COMPLETED PHASE2

Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT04052997

Relapsed Hodgkin Lymphoma Refractory Hodgkin Lymphoma

COMPLETED PHASE2

Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

NCT00540007

Hodgkin Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hodgkin's Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resminostat (4SC-201)

oral administration

Group Type EXPERIMENTAL

Resminostat (4SC-201)

Intervention Type DRUG

oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resminostat (4SC-201)

oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have histological or cytological evidence of Hodgkin's Lymphoma (all subtypes are acceptable)
* Patients must have relapsed or refractory Hodgkin's Lymphoma (HL) defined as relapse following initial therapy or lack of response to first line therapy and treatment with second-line (salvage therapy). Patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry
* Patients must have measurable anatomical disease present on CT scan
* Patients must have an ECOG Performance Score of 0, 1 or 2

Exclusion Criteria

* Patients who have received previous treatment with an HDAC inhibitor
* Patients who have undergone allogeneic hematopoietic stem cell transplantation
* Patients with known or suspected involvement of the CNS by HL
* Patients treated with agents known to prolong the QT interval or with a confirmed QTcF \> 450 msec
* Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA \< 0.1 ng/ml; or cervical intraepithelial neoplasia
* Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring \> 2 medications for adequate control; diabetes mellitus with \> 2 episodes of ketoacidosis in the preceding 12 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No