PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma

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. Identifier: NCT00512980
Recruitment Status : Terminated (lower recruitment rates as expected)
First Posted : August 8, 2007
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

Brief Summary:
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma
Study Start Date : August 2008
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: prednisone
Drug: vinblastine
Drug: doxorubicin
Drug: gemcitabine
Active Comparator: 2 Drug: prednisone
Drug: vinblastine
Drug: doxorubicin
Drug: gemcitabine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed diagnosis of Hodgkin's lymphoma
  2. Stage

    • Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below
    • Clinical Stage IIB with one or both risk factors c-d given below risk factors:

      • Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray)
      • Extranodal involvement
      • High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms)
      • Three or more involved lymph node areas
  3. No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation)
  4. Age: 18-60 years
  5. Signed informed consent with understanding of the study procedures and the investigational nature of the study
  6. Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
  7. Life expectancy > 3 months according to investigator judgement.

Exclusion Criteria:

  1. Incomplete diagnosis of stage of disease
  2. Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications:

    • Chronic obstructive pulmonary disease with global insufficiency
    • Symptomatic coronary heart disease
    • Cardiomyopathy or cardiac insufficiency (NYHA value of EF < 50% or FS < 25%)
    • Serious uncontrolled hypertension
    • Uncontrollable infection
    • Leucocyte concentration < 3.000/mm3 or thrombocyte concentration < 100.000/mm3
    • Creatinin clearance < 60 ml/min
    • Bilirubin > 2 mg/dl or GPT > 100 U/l or GOT > 100 U/I (exception: elevated values of Hodgkin`s disease liver involvement)
    • HIV-Infection according to HIV test
    • Chronic or acute Hepatitis
  3. HD as composite lymphoma
  4. Prior chemotherapy or radiation
  5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
  6. Pregnancy, lactation, positive pregnancy test
  7. Refusal to use effective contraception
  8. WHO performance index > 2
  9. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
  10. Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
  11. Non compliance: Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible
  12. Antiepileptic treatment
  13. General intolerance of any protocol medication
  14. Any contraindication for study medication according to the summaries of product information
  15. Simultaneous participation in another clinical
  16. Institutionalization by law
  17. Relation of dependence with the sponsor`s representative / trialist

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 identifier (NCT number): NCT00512980

University of Cologne
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Principal Investigator: Andreas Engert, Prof University of Cologne

Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne Identifier: NCT00512980     History of Changes
Other Study ID Numbers: PVAG-14 pilot
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Prof. Dr. Andreas Engert, University of Cologne:
intermediate stages

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists