Clinical trial NCT00512980 (phase 2, status: terminated)
Conditions: hodgkin lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: prednisone, vinblastine, doxorubicin, gemcitabine
SMILES: [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, N[C@@H](CCCNC(N)=N)C(O)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    lower recruitment rates as expected
  
Eligibility criteria:

        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