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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: bleomycin sulfate
* Drug: ABVD regimen
* Drug: carmustine
* Drug: cisplatin
* Drug: cytarabine
* Drug: dacarbazine
* Drug: dexamethasone
* Drug: doxorubicin hydrochloride
* Drug: etoposide
* Drug: gemcitabine hydrochloride
* Drug: ifosfamide
* Drug: melphalan
* Drug: methylprednisolone
* Drug: mitoguazone
* Drug: vincristine sulfate
* Drug: vindesine
* Drug: vinorelbine tartrate
* Procedure: allogeneic hematopoietic stem cell transplantation
* Procedure: autologous hematopoietic stem cell transplantation


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Life expectancy > 3 months LVEF normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be able to undergo follow-up for ≥ 15 years No impaired cardiac function that would preclude the administration of an anthracycline No other prior or concurrent malignancy, except for carcinoma in situ of the cervix or basal cell skin cancer No respiratory, kidney, or liver failure or other severe clinical insufficiency that would preclude study treatment No HIV or hepatitis B virus positivity No other disease that would preclude treatment with chemotherapy or radiotherapy EXCLUSION CRITERIA: No concurrent participation in another experimental trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (favorable prognosis)<br>Patients receive ABVD and VABEM chemotherapy. | Biological: bleomycin sulfate<br>* Given IV<br>Drug: ABVD regimen<br>* Given IV<br>Drug: carmustine<br>* Given IV<br>Drug: dacarbazine<br>* Given IV<br>Drug: doxorubicin hydrochloride<br>* Given IV<br>Drug: etoposide<br>* Given IV<br>Drug: methylprednisolone<br>* Given IV<br>Drug: vincristine sulfate<br>* Given IV<br>Drug: vindesine<br>* Given IV<br>|
| Experimental: Group 2 (intermediate prognosis)<br>Patients receive ABVD and VABEM chemotherapy. | Biological: bleomycin sulfate<br>* Given IV<br>Drug: ABVD regimen<br>* Given IV<br>Drug: carmustine<br>* Given IV<br>Drug: dacarbazine<br>* Given IV<br>Drug: doxorubicin hydrochloride<br>* Given IV<br>Drug: etoposide<br>* Given IV<br>Drug: methylprednisolone<br>* Given IV<br>Drug: vincristine sulfate<br>* Given IV<br>Drug: vindesine<br>* Given IV<br>|
| Experimental: Group 3 (poor prognosis)<br>Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. | Drug: carmustine<br>* Given IV<br>Drug: cisplatin<br>* Given IV<br>Drug: cytarabine<br>* Given IV<br>Drug: dexamethasone<br>* Given orally<br>Drug: doxorubicin hydrochloride<br>* Given IV<br>Drug: etoposide<br>* Given IV<br>Drug: gemcitabine hydrochloride<br>* Given IV<br>Drug: ifosfamide<br>* Given IV<br>Drug: melphalan<br>* Given IV<br>Drug: methylprednisolone<br>* Given IV<br>Drug: mitoguazone<br>* Given IV<br>Drug: vindesine<br>* Given IV<br>Drug: vinorelbine tartrate<br>* Given IV<br>Procedure: allogeneic hematopoietic stem cell transplantation<br>* Patients undergo allogeneic stem cell transplantation<br>Procedure: autologous hematopoietic stem cell transplantation<br>* Patients undergo autologous stem cell transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | event free survival | treatments evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma