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

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Terminated

CT.gov ID

NCT00920153

Collaborator

(none)

442

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	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	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

442 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 (favorable prognosis) Patients receive ABVD and VABEM chemotherapy.	Biological: bleomycin sulfate Given IV Drug: ABVD regimen Given IV Drug: carmustine Given IV Drug: dacarbazine Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: methylprednisolone Given IV Drug: vincristine sulfate Given IV Drug: vindesine Given IV
Experimental: Group 2 (intermediate prognosis) Patients receive ABVD and VABEM chemotherapy.	Biological: bleomycin sulfate Given IV Drug: ABVD regimen Given IV Drug: carmustine Given IV Drug: dacarbazine Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: methylprednisolone Given IV Drug: vincristine sulfate Given IV Drug: vindesine Given IV
Experimental: Group 3 (poor prognosis) Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.	Drug: carmustine Given IV Drug: cisplatin Given IV Drug: cytarabine 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: 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

Arm

Intervention/Treatment

Experimental: Group 1 (favorable prognosis)

Patients receive ABVD and VABEM chemotherapy.

Biological: bleomycin sulfate

Given IV

Drug: ABVD regimen

Given IV

Drug: carmustine

Given IV

Drug: dacarbazine

Given IV

Drug: doxorubicin hydrochloride

Given IV

Drug: etoposide

Given IV

Drug: methylprednisolone

Given IV

Drug: vincristine sulfate

Given IV

Drug: vindesine

Given IV

Experimental: Group 2 (intermediate prognosis)

Patients receive ABVD and VABEM chemotherapy.

Biological: bleomycin sulfate

Given IV

Drug: ABVD regimen

Given IV

Drug: carmustine

Given IV

Drug: dacarbazine

Given IV

Drug: doxorubicin hydrochloride

Given IV

Drug: etoposide

Given IV

Drug: methylprednisolone

Given IV

Drug: vincristine sulfate

Given IV

Drug: vindesine

Given IV

Experimental: Group 3 (poor prognosis)

Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.

Drug: carmustine

Given IV

Drug: cisplatin

Given IV

Drug: cytarabine

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: 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

Outcome Measures

Primary Outcome Measures

Event-free survival [treatments evaluation]
event free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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