Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
NCT ID: NCT00920153
Last Updated: 2016-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
442 participants
INTERVENTIONAL
2008-05-31
2016-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
bleomycin sulfate
Given IV
ABVD regimen
Given IV
carmustine
Given IV
dacarbazine
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
methylprednisolone
Given IV
vincristine sulfate
Given IV
vindesine
Given IV
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
bleomycin sulfate
Given IV
ABVD regimen
Given IV
carmustine
Given IV
dacarbazine
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
methylprednisolone
Given IV
vincristine sulfate
Given IV
vindesine
Given IV
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
carmustine
Given IV
cisplatin
Given IV
cytarabine
Given IV
dexamethasone
Given orally
doxorubicin hydrochloride
Given IV
etoposide
Given IV
gemcitabine hydrochloride
Given IV
ifosfamide
Given IV
melphalan
Given IV
methylprednisolone
Given IV
mitoguazone
Given IV
vindesine
Given IV
vinorelbine tartrate
Given IV
allogeneic hematopoietic stem cell transplantation
Patients undergo allogeneic stem cell transplantation
autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation
Interventions
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bleomycin sulfate
Given IV
ABVD regimen
Given IV
carmustine
Given IV
cisplatin
Given IV
cytarabine
Given IV
dacarbazine
Given IV
dexamethasone
Given orally
doxorubicin hydrochloride
Given IV
etoposide
Given IV
gemcitabine hydrochloride
Given IV
ifosfamide
Given IV
melphalan
Given IV
methylprednisolone
Given IV
mitoguazone
Given IV
vincristine sulfate
Given IV
vindesine
Given IV
vinorelbine tartrate
Given IV
allogeneic hematopoietic stem cell transplantation
Patients undergo allogeneic stem cell transplantation
autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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French Innovative Leukemia Organisation
OTHER
Responsible Party
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Principal Investigators
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Delphine Senecal
Role: PRINCIPAL_INVESTIGATOR
French Innovative Leukemia Organization
Locations
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FILO French Innovative Leukemia Organization
Tours, , France
Countries
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Other Identifiers
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LH 2007
Identifier Type: -
Identifier Source: org_study_id
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