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CompletedNCT01037478SAPHIREUpdated Jan 16, 2014

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

A Phase 2 interventional study of Resminostat (4SC-201) in Hodgkin's Lymphoma, sponsored by 4SC AG. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-16.

Sponsored by 4SC AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hodgkin's Lymphoma

Keywords

  • Hodgkin's Lymphoma
  • HDAC
  • 4SC-201
  • Resminostat
  • Phase II
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 37 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

4SC AG is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Eligibility criteria

Main 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

Main 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Resminostat (4SC-201)

    oral administration

    Drug: Resminostat (4SC-201)

Interventions

  • DrugResminostat (4SC-201)

    oral administration

06

What researchers measure

Primary outcomes

  1. Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma.

    Time frame: 12 weeks

Secondary outcomes

  1. Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)

    Time frame: 12 weeks

  2. Assessment of the overall survival (OS)

    Time frame: 12 weeks

  3. Determination of progression free survival (PFS), including radiological and symptomatic progression

    Time frame: 12 weeks

  4. Determination of time to progression (TTP), including objective and symptomatic progression

    Time frame: 12 weeks

  5. Determination of duration of response (DOR)

    Time frame: 12 weeks

  6. Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing

    Time frame: 12 weeks

07

Study locations

10 sites
  • Fakultní nemocnice Brno
    Brno, Czech Republic
  • Fakultní nemocnice Hradec Kralové
    Hradec Kralové, Czech Republic
  • Fakultní nemocnice Kralovske Vinohrady
    Praha, Czech Republic
  • Uniwersyteckie Centrum Kliniczne
    Gdańsk, Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu
    Poznan, Poland
  • Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii
    Warsaw, Poland
  • Wojskowy Instytut Medyczny
    Warsaw, Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu
    Wroclaw, Poland
  • Institutul Clinic Fundeni
    Bucharest, Romania
  • Spitalul Clinic Coltea
    Bucharest, Romania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01037478
Lead sponsor
4SC AG
First posted
Dec 23, 2009
Start date
Dec 2009
Primary completion
Jan 2012
Completion
Mar 2013
Last update
Jan 16, 2014

Study contacts

Jan Walewski, Prof.
principal investigator · Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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