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JAK-inhibition in Recurrent Classical Hodgkin Lymphoma (JeRiCHO)

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ClinicalTrials.gov Identifier: NCT02164500
Recruitment Status : Recruiting
First Posted : June 16, 2014
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Bastian von Tresckow, University of Cologne

Brief Summary:

The Purpose of this trial is:

  • to determine the overall response rate (ORR, complete response [CR] + partial response [PR]) in patients with relapsed or refractory HL
  • to determine the safety profile of ruxolitinib in patients with relapsed or refractory HL

Condition or disease Intervention/treatment Phase
Recurrent Classical Hodgkin Lymphoma Drug: Ruxolitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Prospective, Non-randomized, Multicenter Clinical Trial With the JAK-inhibitor Ruxolitinib in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Study Start Date : October 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Ruxolitinib Drug: Ruxolitinib



Primary Outcome Measures :
  1. overall response rate [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • relapsed or refractory HL
  • ECOG <= 2,
  • no major organ dysfunction
  • written informed consent

Exclusion Criteria:

  • history of another primary malignancy ≤ 2 years
  • female patients who are pregnant or breast feeding
  • patients with a known history of HIV seropositivity
  • chronic active hepatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164500


Contacts
Contact: Michael Fuchs ghsg@uk-koeln.de

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany, 50924
Contact: Michael Fuchs       ghsg@uk-koeln.de   
Sponsors and Collaborators
University of Cologne

Additional Information:
Responsible Party: Dr. Bastian von Tresckow, Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT02164500     History of Changes
Other Study ID Numbers: JeRiCHO
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases