Study Stopped
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Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
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
1 other identifier
interventional
442
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 lymphoma
Started May 2008
Typical duration for phase_3 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedSeptember 16, 2016
July 1, 2016
7.8 years
June 12, 2009
September 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free survival
event free survival
treatments evaluation
Study Arms (3)
Group 1 (favorable prognosis)
EXPERIMENTALPatients receive ABVD and VABEM chemotherapy.
Group 2 (intermediate prognosis)
EXPERIMENTALPatients receive ABVD and VABEM chemotherapy.
Group 3 (poor prognosis)
EXPERIMENTALPatients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV
Patients undergo allogeneic stem cell transplantation
Patients undergo autologous stem cell transplantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No concurrent participation in another experimental trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
FILO French Innovative Leukemia Organization
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delphine Senecal
French Innovative Leukemia Organization
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 15, 2009
Study Start
May 1, 2008
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
September 16, 2016
Record last verified: 2016-07