Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatments doxorubicine, dtic, lenalidomide, vinblastine
Phase phase 1
Sponsor University of Cologne
Start date April 2010
End date April 2014
Trial size 30 participants
Trial identifier NCT01056679, AVD-Rev

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
doxorubicine
50mg/m2 day 1 + 15
dtic
375mg/m2 day 1 + 15
lenalidomide
day 1 - 21
vinblastine
6mg/m2 day 1 + 15

Primary Outcomes

Measure
Dose limiting toxicities (DLT)
time frame:

Secondary Outcomes

Measure
Overall response rate (ORR)
time frame:
Progression free survival (PFS)
time frame: 2 years

Eligibility Criteria

Male or female participants from 60 years up to 75 years old.

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

Additional Information

Official title Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
Principal investigator Andreas Engert, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Cologne.