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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
ClinicalTrials.gov Identifier:
NCT01056679
First received: September 8, 2009
Last updated: June 12, 2014
Last verified: June 2014
  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: 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 University of Cologne:

Primary Outcome Measures:
  • Dose limiting toxicities (DLT) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate (ORR) [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
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

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01056679     History of Changes
Other Study ID Numbers: AVD-Rev
Study First Received: September 8, 2009
Last Updated: June 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 11, 2014