Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
Primary Purpose
Lymphoma
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
bleomycin sulfate
ABVD regimen
carmustine
cisplatin
cytarabine
dacarbazine
dexamethasone
doxorubicin hydrochloride
etoposide
gemcitabine hydrochloride
ifosfamide
melphalan
methylprednisolone
mitoguazone
vincristine sulfate
vindesine
vinorelbine tartrate
allogeneic hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Eligibility Criteria
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
Sites / Locations
- FILO French Innovative Leukemia Organization
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1 (favorable prognosis)
Group 2 (intermediate prognosis)
Group 3 (poor prognosis)
Arm Description
Patients receive ABVD and VABEM chemotherapy.
Patients receive ABVD and VABEM chemotherapy.
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
Outcomes
Primary Outcome Measures
Event-free survival
event free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00920153
First Posted
June 12, 2009
Last Updated
September 15, 2016
Sponsor
French Innovative Leukemia Organisation
1. Study Identification
Unique Protocol Identification Number
NCT00920153
Brief Title
Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Other new drugs
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (favorable prognosis)
Arm Type
Experimental
Arm Description
Patients receive ABVD and VABEM chemotherapy.
Arm Title
Group 2 (intermediate prognosis)
Arm Type
Experimental
Arm Description
Patients receive ABVD and VABEM chemotherapy.
Arm Title
Group 3 (poor prognosis)
Arm Type
Experimental
Arm Description
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
ABVD regimen
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
mitoguazone
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
vindesine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
allogeneic hematopoietic stem cell transplantation
Intervention Description
Patients undergo allogeneic stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
autologous hematopoietic stem cell transplantation
Intervention Description
Patients undergo autologous stem cell transplantation
Primary Outcome Measure Information:
Title
Event-free survival
Description
event free survival
Time Frame
treatments evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine Senecal
Organizational Affiliation
French Innovative Leukemia Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
FILO French Innovative Leukemia Organization
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
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