LymphomaPhase 2073NCT00869284
Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas
A Phase 2 study testing CEEP regimen and Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC) in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CEEP regimen and Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Oct 1994to Feb 2009
- Phase
- Phase 2
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients aged from 15 to 60 years
- previously untreated
- histologically proven aggressive NHL
- high aa-IPI (equal to 3)
- proper underlying organ function
Who cannot join
- transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
Read the detailed description
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years
- Conditions
- Lymphoma
- Being tested
- CEEP regimen, Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)
- Keywords
- High-dose chemotherapy, aggressive NHL, high-risk, PBSC
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEEP regimenDrug
cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals
Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)Procedure or surgery
The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4.
The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
Measured: end of treatment
Secondary outcomes (1)
overall survival disease free survival
Measured: 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startOct 1994
- Primary completionJul 1999
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Noël MILPIED, MDPD, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869284
- Sponsor's protocol ID
- GOELAMS 073
- Other IDs
- no other identification number
- Acronym
- 073
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2009
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, Francois S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.
PubMed 21109011
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00869284
- Acronym / sponsor ID
- 073 / GOELAMS 073
- Conditions
- Lymphoma
- Keywords
- High-dose chemotherapy, aggressive NHL, high-risk, PBSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Oct 1994
- Primary completion
- Jul 1999 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 25 Mar 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.
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
Detailed description
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- patients aged from 15 to 60 years
- previously untreated
- histologically proven aggressive NHL
- high aa-IPI (equal to 3)
- proper underlying organ function
Key exclusion criteria (1 listed)
- transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
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 |
|---|---|---|
| CEEP regimencyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals | Drug | – |
| Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4. The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8. | Procedure or surgery | – |
Primary outcome
Complete response
Time frame: end of treatment
1 secondary outcome
overall survival disease free survival
Time frame: 10 years after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
- Derived from this study: PubMed 21109011Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, Francois S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.
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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.
Noël MILPIED, MDPD principal investigator
French Innovative Leukemia Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CEEP regimen and Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC) 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 5 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: finished, as of the sponsor's last update on 25 Mar 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete response (time frame: end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869284, which also lists 1 linked publication.
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 25 Mar 2009.