PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma

A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma

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

Study Overview

• Status: Terminated
• Conditions: Hodgkin Lymphoma
• Intervention / Treatment: Drug: prednisone; Drug: gemcitabine; Drug: doxorubicin; Drug: vinblastine

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • University of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: prednisone; Drug: gemcitabine; Drug: doxorubicin; Drug: vinblastine
Active Comparator: 1	Drug: prednisone; Drug: gemcitabine; Drug: doxorubicin; Drug: vinblastine

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Andreas Engert, Prof, University of Cologne

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 7, 2007
• First Submitted That Met QC Criteria: August 7, 2007
• First Posted (Estimate): August 8, 2007

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: intermediate stages
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Gemcitabine; Prednisone; Doxorubicin; Vinblastine
• Other Study ID Numbers: PVAG-14 pilot