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

Phase 2
18 Years
60 Years
Not Enrolling
Hodgkin Lymphoma

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Trial Information

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

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 <

- 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

12. Antiepileptic treatment

13. General intolerance of any protocol medication

14. Any contraindication for study medication according to the summaries of product

15. Simultaneous participation in another clinical

16. Institutionalization by law

17. Relation of dependence with the sponsor`s representative / trialist

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Principal Investigator

Andreas Engert, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cologne


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PVAG-14 pilot



Start Date:

August 2008

Completion Date:

Related Keywords:

  • Hodgkin Lymphoma
  • intermediate stages
  • Hodgkin Disease
  • Lymphoma