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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01056679
Other study ID # AVD-Rev
Secondary ID
Status Completed
Phase Phase 1
First received September 8, 2009
Last updated March 21, 2018
Start date April 2010
Est. completion date February 2016

Study information

Verified date March 2018
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2016
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Doxorubicine
50mg/m2 day 1 + 15
DTIC
375mg/m2 day 1 + 15
Lenalidomide
day 1 - 21
Vinblastine
6mg/m2 day 1 + 15

Locations

Country Name City State
Germany 1st Dept. of Medicine, Cologne University Hospital Cologne NRW

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicities (DLT)
Secondary Overall response rate (ORR)
Secondary Progression free survival (PFS) 2 years
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