- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02164500
JAK-inhibition in Recurrent Classical Hodgkin Lymphoma (JeRiCHO)
April 3, 2020 updated by: Dr. Bastian von Tresckow, University of Cologne
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cologne, Germany, 50924
- 1st Dept. of Medicine, Cologne University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ruxolitinib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
May 17, 2019
Study Completion (Actual)
May 17, 2019
Study Registration Dates
First Submitted
June 12, 2014
First Submitted That Met QC Criteria
June 12, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Actual)
April 6, 2020
Last Update Submitted That Met QC Criteria
April 3, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JeRiCHO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Classical Hodgkin Lymphoma
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Northwestern UniversityNational Cancer Institute (NCI); Merck Sharp & Dohme LLCActive, not recruitingLymphocyte-Rich Classical Hodgkin Lymphoma | Recurrent Lymphocyte-Depleted Classical Hodgkin Lymphoma | Recurrent Mixed Cellularity Classical Hodgkin Lymphoma | Recurrent Nodular Sclerosis Classical Hodgkin Lymphoma | Refractory Lymphocyte-Depleted Classical Hodgkin Lymphoma | Refractory Mixed... and other conditionsUnited States
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Northwestern UniversityNational Cancer Institute (NCI); Merck Sharp & Dohme LLCActive, not recruitingClassical Hodgkin Lymphoma | Lymphocyte-Depleted Classical Hodgkin Lymphoma | Lymphocyte-Rich Classical Hodgkin Lymphoma | Mixed Cellularity Classical Hodgkin Lymphoma | Nodular Sclerosis Classical Hodgkin LymphomaUnited States
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Shandong New Time Pharmaceutical Co., LTDUnknownAdvanced Solid Tumor,Recurrent Solid Tumor,Lymphoma,Recurrent Lymphocyte Depleted Classical Hodgkin LymphomaChina
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruitingRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Classical Hodgkin LymphomaUnited States
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingHodgkin Lymphoma | Recurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Classical Hodgkin LymphomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Childhood Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Mixed Cellularity... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland, Israel
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Sun Yat-sen UniversityRecruitingClassical Hodgkin Lymphoma | Refractory or Relapsed Classical Hodgkin LymphomaChina
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TakedaCompletedClassical Hodgkin Lymphoma | Relapsed or Refractory Classical Hodgkin LymphomaKorea, Republic of
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Tianjin Medical University Cancer Institute and...Enrolling by invitationRecurrent/Refractory Classical Hodgkin's LymphomaChina
-
Tessa TherapeuticsBristol-Myers SquibbActive, not recruitingClassical Hodgkin Lymphoma | Hodgkin Disease Recurrent | Hodgkin Disease RefractoryUnited States
Clinical Trials on Ruxolitinib
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First Affiliated Hospital of Zhejiang UniversityXiangya Hospital of Central South University; Second Affiliated Hospital, School... and other collaboratorsRecruitingHematologic Malignancy | Bronchiolitis Obliterans SyndromeChina
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Novartis PharmaceuticalsTerminatedMyelofibrosis With High Molecular Risk MutationsBelgium, Spain, United Kingdom, Hungary, Italy, Japan, Taiwan, Germany, Canada, Singapore, Austria, Australia, France, Israel, Sweden, Switzerland, Hong Kong, Greece, Turkey, Brazil, Russian Federation, Denmark, Portugal, Norway, Poland
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Incyte CorporationActive, not recruiting
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Julie NangiaIncyte Corporation; Translational Breast Cancer Research ConsortiumRecruitingDuctal Carcinoma In Situ | Atypical Ductal Hyperplasia | Atypical Lobular Hyperplasia | Lobular Carcinoma In SituUnited States
-
Beijing Friendship HospitalUnknownHemophagocytic LymphohistiocytosisChina
-
Children's Hospital Medical Center, CincinnatiRecruitingBronchiolitis Obliterans (BO) | Hematopoietic Stem Cell Transplant (HSCT)United States
-
University of JenaCompleted
-
University of Michigan Rogel Cancer CenterCompletedHemophagocytic Syndrome (HPS)United States
-
Margherita MaffioliUnknown
-
University of PittsburghWithdrawnHead and Neck Squamous Cell Carcinoma