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Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma (HD-R3i)

Primary Purpose

Hodgkin Lymphoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
DHAP
Everolimus
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1st Dept. of Medicine, Cologne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ever-DHAP

Placebo-DHAP

Arm Description

Combination of Everolimus and DHAP

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity Rate (DLT)
Phase I primary outcome measure
Complete Remission Rate (CR)
Phase II primary outcome measure

Secondary Outcome Measures

Adverse event rate
Phase I secondary outcome measure
Tumor status (assessed by CT) after chemotherapy
Phase II secondary outcome measure
Tumor status (assessed by PET) after chemotherapy
Phase II secondary outcome measure

Full Information

First Posted
October 17, 2011
Last Updated
November 7, 2019
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01453504
Brief Title
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma
Acronym
HD-R3i
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 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 recommended dose of everolimus for a subsequent Phase II trial to determine the efficacy of everolimus plus DHAP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ever-DHAP
Arm Type
Active Comparator
Arm Description
Combination of Everolimus and DHAP
Arm Title
Placebo-DHAP
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DHAP
Intervention Description
Dexamethasone, Cytarabine, Cisplatin
Intervention Type
Drug
Intervention Name(s)
Everolimus
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity Rate (DLT)
Description
Phase I primary outcome measure
Time Frame
4 weeks
Title
Complete Remission Rate (CR)
Description
Phase II primary outcome measure
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse event rate
Description
Phase I secondary outcome measure
Time Frame
4 weeks
Title
Tumor status (assessed by CT) after chemotherapy
Description
Phase II secondary outcome measure
Time Frame
4 weeks
Title
Tumor status (assessed by PET) after chemotherapy
Description
Phase II secondary outcome measure
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Borchmann, Prof.
Organizational Affiliation
University of Cologne, German Hodgkin Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.ghsg.org
Description
Homepage GHSG

Learn more about this trial

Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma

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