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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056679
First Posted: January 26, 2010
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
  Purpose
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 Intervention Phase
Hodgkin Lymphoma Drug: Doxorubicine Drug: DTIC Drug: Lenalidomide Drug: Vinblastine Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Prof. Dr. Andreas Engert, University of Cologne:

Primary Outcome Measures:
  • Dose limiting toxicities (DLT)

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

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: September 8, 2009
First Posted: January 26, 2010
Last Update Posted: November 2, 2015
Last Verified: October 2015

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


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