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

Phase 3

Terminated

• Conditions: Lymphoma
• Interventions: Biological: bleomycin sulfate; Drug: ABVD regimen; Drug: cisplatin; Drug: carmustine; Drug: cytarabine; Drug: dacarbazine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: gemcitabine hydrochloride; Drug: methylprednisolone; Drug: vincristine sulfate; Drug: ifosfamide; Drug: vindesine; Drug: melphalan; Drug: mitoguazone; Drug: vinorelbine tartrate; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: 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.
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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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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 2 (intermediate prognosis)	methylprednisolone	Patients receive ABVD and VABEM chemotherapy.
Group 1 (favorable prognosis)	methylprednisolone	Patients receive ABVD and VABEM chemotherapy.
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)	mitoguazone	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.

Primary Outcome Measures

Name	Time	Method
Event-free survival	treatments evaluation	event free survival

Trial Locations

Locations (1)

FILO French Innovative Leukemia Organization; 🇫🇷 Tours Cedex, France