Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: bleomycin sulfateDrug: ABVD regimenProcedure: allogeneic hematopoietic stem cell transplantationProcedure: autologous hematopoietic stem cell transplantation
- Registration Number
- NCT00920153
- Lead Sponsor
- French Innovative Leukemia Organisation
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.
PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 442
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 2 (intermediate prognosis) dacarbazine Patients receive ABVD and VABEM chemotherapy. Group 1 (favorable prognosis) bleomycin sulfate Patients receive ABVD and VABEM chemotherapy. Group 1 (favorable prognosis) ABVD regimen Patients receive ABVD and VABEM chemotherapy. Group 3 (poor prognosis) gemcitabine hydrochloride Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 1 (favorable prognosis) vincristine sulfate Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) bleomycin sulfate Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) vincristine sulfate Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) ABVD regimen Patients receive ABVD and VABEM chemotherapy. Group 3 (poor prognosis) vinorelbine tartrate Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) allogeneic hematopoietic stem cell transplantation Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) autologous hematopoietic stem cell transplantation Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) dexamethasone Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 1 (favorable prognosis) dacarbazine Patients receive ABVD and VABEM chemotherapy. Group 1 (favorable prognosis) carmustine Patients receive ABVD and VABEM chemotherapy. Group 1 (favorable prognosis) doxorubicin hydrochloride Patients receive ABVD and VABEM chemotherapy. Group 1 (favorable prognosis) etoposide Patients receive ABVD and VABEM chemotherapy. Group 1 (favorable prognosis) vindesine Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) vindesine Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) carmustine Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) doxorubicin hydrochloride Patients receive ABVD and VABEM chemotherapy. Group 2 (intermediate prognosis) etoposide Patients receive ABVD and VABEM chemotherapy. Group 3 (poor prognosis) carmustine Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) doxorubicin hydrochloride Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) cisplatin Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) cytarabine Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) etoposide Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) ifosfamide Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) melphalan Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) vindesine Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 3 (poor prognosis) methylprednisolone Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 2 (intermediate prognosis) methylprednisolone Patients receive ABVD and VABEM chemotherapy. Group 3 (poor prognosis) mitoguazone Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Group 1 (favorable prognosis) methylprednisolone Patients receive ABVD and VABEM chemotherapy.
- Primary Outcome Measures
Name Time Method Event-free survival treatments evaluation event free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FILO French Innovative Leukemia Organization
🇫🇷Tours Cedex, France