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

Phase 1

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Doxorubicine; Drug: DTIC; Drug: Lenalidomide; Drug: Vinblastine

• Registration Number: NCT01056679
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-04
• Primary Completion: 2014-04
• Study Completion: 2016-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AVD-Rev	Doxorubicine	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
AVD-Rev	DTIC	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
AVD-Rev	Lenalidomide	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
AVD-Rev	Vinblastine	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

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLT)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)
Progression free survival (PFS)	2 years

Trial Locations

Locations (1)

1st Dept. of Medicine, Cologne University Hospital; 🇩🇪 Cologne, NRW, Germany