Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrene at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma
OBJECTIVES:
Primary
- Evaluate event-free survival.
Secondary
- Evaluate overall survival.
- Evaluate the prognostic value of FDG-PET scanning.
- Evaluate progression-free survival.
- Evaluate tolerability.
- Evaluate rate of relapse.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups
according to prognosis.
- Group 1 (favorable prognosis): Patients receive ABVD chemotherapy comprising
doxorubicin hydrochloride IV, bleomycin sulfate IV, vincristine sulfate IV, dacarbazine
IV, and methylprednisolone IV on days 1 and 14. Treatment repeats every 28 days for 2
courses. Patients then undergo PET scan for evaluation of response. Patients receive
additional treatment according to response.
- Favorable response: Patients with favorable response receive 1 additional course
of ABVD chemotherapy.
- Unfavorable response: Patients with unfavorable response receive 1 course of VABEM
chemotherapy comprising vindesine IV continuously on days 1-5, doxorubicin
hydrochloride IV continuously on days 1-3, carmustine IV on day 3, etoposide IV on
days 3-5, and methylprednisolone IV on days 1-5.
- Group 2 (intermediate prognosis): Patients receive 2 courses of ABVD chemotherapy.
Patients then undergo PET scan for evaluation of response. Patients receive additional
treatment according to response.
- Favorable response: Patients with favorable response receive 4 additional courses
of ABVD chemotherapy.
- Unfavorable response: Patients with unfavorable response receive VABEM
chemotherapy. Treatment with VABEM chemotherapy repeats every 28 days for 2
courses.
- Group 3 (poor prognosis): Patients receive 2 courses of VABEM chemotherapy. Patients
then undergo PET scan for evaluation of response. Patients receive additional treatment
according to response.
- Favorable response: Patients with favorable response receive 1 additional course
of VABEM chemotherapy.
- Unfavorable response: Patients with unfavorable response receive CEO chemotherapy
comprising cisplatin IV continuously on days 1-3, gemcitabine hydrochloride IV on
days 1 and 8, and oral dexamethasone once daily on days 1-4. Treatment repeats
every 21 days for 3 courses. Patients then undergo PET scan. Patients receive
additional treatment according to response.
- Favorable response: Patients with favorable response receive BEAM
chemotherapy comprising carmustine IV on day -7, etoposide IV and cytarabine
IV on days -6 to -3, and melphalan IV on day -2. Patients then undergo
autologous stem cell transplantation on day 0.
- Unfavorable response: Patients with unfavorable response receive MINE
chemotherapy comprising mitoguazone IV, vinorelbine ditartrate IV, and
ifosfamide IV on days 1-5 and etoposide IV on days 1-3. Treatment repeats
every 28 days for 3 courses. Patients then undergo allogeneic or autologous
stem cell transplantation.
Patients with favorable response or a "bulky" mass at diagnosis may also undergo
radiotherapy.
After completion of study treatment, patients are followed periodically for 15 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Event-free survival
No
Delphine Senecal
Principal Investigator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Unspecified
CDR0000633503
NCT00920153
May 2008
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