- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453504
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma (HD-R3i)
November 7, 2019 updated by: Prof. Dr. Peter Borchmann, University of Cologne
A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
The purpose of this trial is
- to determine the recommended dose of everolimus for a subsequent Phase II trial
- to determine the efficacy of everolimus plus DHAP
Study Overview
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Phase 2
- Phase 1
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
- 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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- relapsed or refractory Hodgkin Lymphoma
- age 18-60
- histology confirmed relapse
Exclusion Criteria:
- previous therapy with mTOR inhibitor
- current CNS involvement
- other primary malignant disease within the last 3 years
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ever-DHAP
Combination of Everolimus and DHAP
|
Dexamethasone, Cytarabine, Cisplatin
|
Placebo Comparator: Placebo-DHAP
|
Dexamethasone, Cytarabine, Cisplatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicity Rate (DLT)
Time Frame: 4 weeks
|
Phase I primary outcome measure
|
4 weeks
|
Complete Remission Rate (CR)
Time Frame: 4 weeks
|
Phase II primary outcome measure
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event rate
Time Frame: 4 weeks
|
Phase I secondary outcome measure
|
4 weeks
|
Tumor status (assessed by CT) after chemotherapy
Time Frame: 4 weeks
|
Phase II secondary outcome measure
|
4 weeks
|
Tumor status (assessed by PET) after chemotherapy
Time Frame: 4 weeks
|
Phase II secondary outcome measure
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Peter Borchmann, Prof., University of Cologne, German Hodgkin Study Group
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
August 1, 2012
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
October 17, 2011
First Submitted That Met QC Criteria
October 17, 2011
First Posted (Estimate)
October 18, 2011
Study Record Updates
Last Update Posted (Actual)
November 8, 2019
Last Update Submitted That Met QC Criteria
November 7, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD-R3i
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.
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National Cancer Institute (NCI)CompletedRecurrent Adult Hodgkin Lymphoma | Adult Lymphocyte Depletion Hodgkin Lymphoma | Adult Lymphocyte Predominant Hodgkin Lymphoma | Adult Mixed Cellularity Hodgkin Lymphoma | Adult Nodular Sclerosis Hodgkin Lymphoma | Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma | Adult Favorable Prognosis... and other conditionsUnited States
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-
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