NCT00920153

Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma

Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate	Given IV
DRUG	ABVD regimen	Given IV
DRUG	carmustine	Given IV
DRUG	cisplatin	Given IV
DRUG	cytarabine	Given IV
DRUG	dacarbazine	Given IV
DRUG	dexamethasone	Given orally
DRUG	doxorubicin hydrochloride	Given IV
DRUG	etoposide	Given IV
DRUG	gemcitabine hydrochloride	Given IV
DRUG	ifosfamide	Given IV
DRUG	melphalan	Given IV
DRUG	methylprednisolone	Given IV
DRUG	mitoguazone	Given IV
DRUG	vincristine sulfate	Given IV
DRUG	vindesine	Given IV
DRUG	vinorelbine tartrate	Given IV
PROCEDURE	allogeneic hematopoietic stem cell transplantation	Patients undergo allogeneic stem cell transplantation
PROCEDURE	autologous hematopoietic stem cell transplantation	Patients undergo autologous stem cell transplantation

Timeline

• Start date: 2008-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2009-06-15
• Last updated: 2016-09-16

Locations

1 site across 1 country: France