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OpenTrials
Completed

NCT Number: NCT01056679

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

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.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1st Dept. of Medicine, Cologne University Hospital

Cologne, North Rhine-Westphalia, 50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicine

Drug

50mg/m2 day 1 + 15

DTIC

Drug

375mg/m2 day 1 + 15

Lenalidomide

Drug

day 1 - 21

Vinblastine

Drug

6mg/m2 day 1 + 15

Primary outcomes

  1. Dose limiting toxicities (DLT)

Secondary outcomes

  1. Overall response rate (ORR)

  2. Progression free survival (PFS)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients

Acronym: AVD-Rev

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Jan 26, 2010
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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