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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01056679
Date of registration: 08/09/2009
Prospective Registration: Yes
Primary sponsor: University of Cologne
Public title: Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients AVD-Rev
Scientific title: Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
Date of first enrolment: April 2010
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01056679
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Germany
Contacts
Name:     Andreas Engert, Prof.
Address: 
Telephone:
Email:
Affiliation:  University of Cologne
Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hodgkin Lymphoma
Intervention(s)
Drug: Doxorubicine
Drug: Vinblastine
Drug: DTIC
Drug: Lenalidomide
Primary Outcome(s)
Dose limiting toxicities (DLT)
Secondary Outcome(s)
Overall response rate (ORR)
Progression free survival (PFS) [Time Frame: 2 years]
Secondary ID(s)
AVD-Rev
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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