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Trial record 1 of 1 for:    Phase I Trial of AVD Plus Lenalidomide (Revlimid)in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
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Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients (AVD-Rev)

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
Dose limiting toxicities (DLT)
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Dose limiting toxicities
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
  • Overall response rate (ORR)
  • Progression free survival (PFS) [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
  • Overall response rate (ORR) [ Time Frame: at final staging ]
  • Progression free survival (PFS) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients
Official Title  ICMJE Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Drug: Doxorubicine
  • Drug: DTIC
  • Drug: Lenalidomide
  • Drug: Vinblastine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 8, 2010)
30
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01056679
Other Study ID Numbers  ICMJE AVD-Rev
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Andreas Engert, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Engert, Prof. University of Cologne
PRS Account University of Cologne
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP