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Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients (AVD-Rev)

Primary Purpose

Hodgkin Lymphoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Doxorubicine
DTIC
Lenalidomide
Vinblastine
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

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hodgkin Lymphoma, intermediate or advanced stage
  • Age >60 and <75 years
  • ECOG 2 or better
  • No major organ dysfunction
  • Ability to take aspirin or LMW Heparin

Exclusion Criteria:

  • HL as composite lymphoma
  • Prior use of lenalidomide
  • Prior use of chemo- or radiotherapy

Sites / Locations

  • 1st Dept. of Medicine, Cologne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVD-Rev

Arm Description

Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLT)

Secondary Outcome Measures

Overall response rate (ORR)
Progression free survival (PFS)

Full Information

First Posted
September 8, 2009
Last Updated
March 21, 2018
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01056679
Brief Title
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients
Acronym
AVD-Rev
Official Title
Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.

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
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVD-Rev
Arm Type
Experimental
Arm Description
Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results
Intervention Type
Drug
Intervention Name(s)
Doxorubicine
Intervention Description
50mg/m2 day 1 + 15
Intervention Type
Drug
Intervention Name(s)
DTIC
Intervention Description
375mg/m2 day 1 + 15
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
day 1 - 21
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
6mg/m2 day 1 + 15
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLT)
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Title
Progression free survival (PFS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hodgkin Lymphoma, intermediate or advanced stage Age >60 and <75 years ECOG 2 or better No major organ dysfunction Ability to take aspirin or LMW Heparin Exclusion Criteria: HL as composite lymphoma Prior use of lenalidomide Prior use of chemo- or radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.ghsg.org
Description
Related Info

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Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients

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