Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or S zary Syndrome (SS)

  • STATUS
    Recruiting
  • End date
    Dec 12, 2022
  • participants needed
    190
  • sponsor
    4SC AG
Updated on 12 December 2020
systemic therapy
interferon
maintenance treatment
chemotherapy regimen
sezary syndrome
renal function test
mycosis
bexarotene
resminostat

Summary

The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Szary Syndrome that have recently achieved disease control with previous systemic therapy.

Details
Treatment Placebo, resminostat
Clinical Study IdentifierNCT02953301
Sponsor4SC AG
Last Modified on12 December 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lymphoproliferative Disorder or cutaneous T-cell lymphoma or Sezary Syndrome or Sézary Syndrome or Lymphoproliferative disorders or Mycosis Fungoides?
Do you have any of these conditions: Lymphoproliferative disorders or Sezary Syndrome or Mycosis Fungoides or Sézary Syndrome or cutaneous T-cell lymphoma or Lymphoproliferative Disorder?
Do you have any of these conditions: Lymphoproliferative Disorder or Mycosis Fungoides or Sézary Syndrome or Sezary Syndrome or cutaneous T-cell lymphoma or Lymphoproliferative disorders?
Do you have any of these conditions: Sézary Syndrome or Lymphoproliferative disorders or Lymphoproliferative Disorder or Mycosis Fungoides or Sezary Syndrome or cutaneous T-cell lymphoma?
Do you have any of these conditions: Lymphoproliferative disorders or cutaneous T-cell lymphoma or Sézary Syndrome or Lymphoproliferative Disorder or Mycosis Fungoides or Sezary Syndrome?
Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing complete response (CR), partial response (PR) or stable disease (SD) after at least one prior systemic therapy according to local standards (including but not limited to -interferon, bexarotene, total skin electron beam irradiation, chemotherapy) [the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-12 weeks prior to randomisation]
Eastern Cooperative Oncology Group (ECOG) status score 0-2
Adequate haematological, hepatic and renal function

Exclusion Criteria

Patients with progressive disease (PD)
Baseline corrected QT (QTc) interval > 500 milliseconds
Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet