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Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients (AVD-Rev)

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ClinicalTrials.gov Identifier: NCT01056679
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, 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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Doxorubicine Drug: DTIC Drug: Lenalidomide Drug: Vinblastine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
Study Start Date : April 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AVD-Rev
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
Drug: Doxorubicine
50mg/m2 day 1 + 15
Drug: DTIC
375mg/m2 day 1 + 15
Drug: Lenalidomide
day 1 - 21
Drug: Vinblastine
6mg/m2 day 1 + 15



Primary Outcome Measures :
  1. Dose limiting toxicities (DLT)

Secondary Outcome Measures :
  1. Overall response rate (ORR)
  2. Progression free survival (PFS) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056679


Locations
Germany
1st Dept. of Medicine, Cologne University Hospital
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof. University of Cologne

Additional Information:
Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01056679     History of Changes
Other Study ID Numbers: AVD-Rev
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Lenalidomide
Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators