JeRiCHO: JAK-inhibition in Recurrent Classical Hodgkin Lymphoma
Sponsor
University of Cologne (Other)
Overall Status
Completed
CT.gov ID
NCT02164500
Collaborator
(none)
12
1
1
43.5
0.3
Study Details
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
N/A
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
:
Oct 1, 2015
Actual Primary Completion Date
:
May 17, 2019
Actual Study Completion Date
:
May 17, 2019
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ruxolitinib
|
Drug: Ruxolitinib
|
Outcome Measures
Primary Outcome Measures
- overall response rate [8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 1st Dept. of Medicine, Cologne University Hospital | Cologne | Germany | 50924 |
Sponsors and Collaborators
- University of Cologne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Dr. Bastian von Tresckow,
Dr.,
University of Cologne
ClinicalTrials.gov Identifier:
NCT02164500
Other Study ID Numbers:
- JeRiCHO
First Posted:
Jun 16, 2014
Last Update Posted:
Apr 6, 2020
Last Verified:
Apr 1, 2020