Back to resultsJAK-inhibition in Recurrent Classical Hodgkin Lymphoma (JeRiCHO)
Primary Purpose
Recurrent Classical Hodgkin Lymphoma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Classical Hodgkin Lymphoma
Eligibility 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
Sites / Locations
- 1st Dept. of Medicine, Cologne University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ruxolitinib
Arm Description
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02164500
Brief Title
JAK-inhibition in Recurrent Classical Hodgkin Lymphoma
Acronym
JeRiCHO
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Classical Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.ghsg.org
Description
Homepage GHSG
Learn more about this trial
JAK-inhibition in Recurrent Classical Hodgkin Lymphoma
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