LymphomaPhase 3NCT00920153
Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
A Phase 3 study testing bleomycin sulfate, ABVD regimen and carmustine in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, ABVD regimen and carmustine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- No concurrent participation in another experimental trial
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, ABVD regimen, carmustine, cisplatin, cytarabine
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
Given IV
ABVD regimenDrug
Given IV
carmustineDrug
Given IV
cisplatinDrug
Given IV
cytarabineDrug
Given IV
dacarbazineDrug
Given IV
dexamethasoneDrug
Given orally
Given IV
etoposideDrug
Given IV
Given IV
ifosfamideDrug
Given IV
melphalanDrug
Given IV
Given IV
mitoguazoneDrug
Given IV
Given IV
vindesineDrug
Given IV
vinorelbine tartrateDrug
Given IV
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Patients undergo allogeneic stem cell transplantation
autologous hematopoietic stem cell transplantationProcedure or surgery
Patients undergo autologous stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (favorable prognosis) | Experimental | Patients receive ABVD and VABEM chemotherapy. Receives: Biological: bleomycin sulfate; Drug: ABVD regimen; Drug: carmustine; Drug: dacarbazine; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: methylprednisolone; Drug: vincristine sulfate; Drug: vindesine |
| Group 2 (intermediate prognosis) | Experimental | Patients receive ABVD and VABEM chemotherapy. Receives: Biological: bleomycin sulfate; Drug: ABVD regimen; Drug: carmustine; Drug: dacarbazine; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: methylprednisolone; Drug: vincristine sulfate; Drug: vindesine |
| Group 3 (poor prognosis) | Experimental | Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. Receives: Drug: carmustine; Drug: cisplatin; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: gemcitabine hydrochloride; Drug: ifosfamide; Drug: melphalan; Drug: methylprednisolone; Drug: mitoguazone; Drug: vindesine; Drug: vinorelbine tartrate; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: autologous hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
event free survival
Measured: treatments evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMay 2008
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Other new drugs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Senecal, Principal investigator, French Innovative Leukemia Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920153
- Sponsor's protocol ID
- LH 2007
- Status last verified
- Jul 2016
- First submitted
- 12 Jun 2009
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00920153
- Acronym / sponsor ID
- LH 2007
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Other new drugs
- Enrolment
- 442 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (favorable prognosis) | Experimental | Biological: bleomycin sulfate, Drug: ABVD regimen, Drug: carmustine, Drug: dacarbazine, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: methylprednisolone, Drug: vincristine sulfate, Drug: vindesinePatients receive ABVD and VABEM chemotherapy. |
| Group 2 (intermediate prognosis) | Experimental | Biological: bleomycin sulfate, Drug: ABVD regimen, Drug: carmustine, Drug: dacarbazine, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: methylprednisolone, Drug: vincristine sulfate, Drug: vindesinePatients receive ABVD and VABEM chemotherapy. |
| Group 3 (poor prognosis) | Experimental | Drug: carmustine, Drug: cisplatin, Drug: cytarabine, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: gemcitabine hydrochloride, Drug: ifosfamide, Drug: melphalan, Drug: methylprednisolone, Drug: mitoguazone, Drug: vindesine, Drug: vinorelbine tartrate, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: autologous hematopoietic stem cell transplantationPatients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Life expectancy > 3 months
- LVEF normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Key exclusion criteria (1 listed)
- No concurrent participation in another experimental trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bleomycin sulfateGiven IV | Biological | Group 1 (favorable prognosis), Group 2 (intermediate prognosis) |
| ABVD regimenGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis) |
| carmustineGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis), Group 3 (poor prognosis) |
| cisplatinGiven IV | Drug | Group 3 (poor prognosis) |
| cytarabineGiven IV | Drug | Group 3 (poor prognosis) |
| dacarbazineGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis) |
| dexamethasoneGiven orally | Drug | Group 3 (poor prognosis) |
| doxorubicin hydrochlorideGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis), Group 3 (poor prognosis) |
| etoposideGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis), Group 3 (poor prognosis) |
| gemcitabine hydrochlorideGiven IV | Drug | Group 3 (poor prognosis) |
| ifosfamideGiven IV | Drug | Group 3 (poor prognosis) |
| melphalanGiven IV | Drug | Group 3 (poor prognosis) |
| methylprednisoloneGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis), Group 3 (poor prognosis) |
| mitoguazoneGiven IV | Drug | Group 3 (poor prognosis) |
| vincristine sulfateGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis) |
| vindesineGiven IV | Drug | Group 1 (favorable prognosis), Group 2 (intermediate prognosis), Group 3 (poor prognosis) |
| vinorelbine tartrateGiven IV | Drug | Group 3 (poor prognosis) |
| allogeneic hematopoietic stem cell transplantationPatients undergo allogeneic stem cell transplantation | Procedure or surgery | Group 3 (poor prognosis) |
| autologous hematopoietic stem cell transplantationPatients undergo autologous stem cell transplantation | Procedure or surgery | Group 3 (poor prognosis) |
Primary outcome
Event-free survival
Time frame: treatments evaluation
event free survival
Results and safety
The study was stopped early (reason given: Other new drugs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine Senecal principal investigator
French Innovative Leukemia Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bleomycin sulfate, ABVD regimen and carmustine in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Other new drugs). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: treatments evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016; AzTrials last refreshed its copy on 3 Nov 2026.