B-Cell LymphomaPhase 3NCT00162656
Treatment of Mature B-cell Lymphoma/Leukaemia
A Phase 3 study testing half cyclophosphamide, without COPADM3 and mini CYVE, without 3 maintenance courses in people with B-Cell Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in 3 countries.
Trial summary
This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- half cyclophosphamide, without COPADM3 and mini CYVE, without 3 maintenance courses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 1996to May 2011
- 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 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow > 5% L3 blasts.
- Pre treatment imaging studies adequate to document Murphy disease stage
- Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts)
- Patients should be available for a minimum follow up of 36 months
- Informed consent prior to study entry
Who cannot join
- Anaplastic large cell Ki 1 positive lymphomas
- Previous chemotherapy.
- Congenital immunodeficiency
- Prior organ transplantation
- Previous malignancy of any type
- Known HIV positivity
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Morgan Stanley Childrens Hospital of New York Presbyterian
New York, New York
About this study
Official title: Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study
This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
Read the detailed description
Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89 therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both reduction and deletion. Randomization occurs following COPADM1 and is stratified for national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy III+LDH<2N; Murphy III+LDH>2N or Murphy IV).
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2 and is stratified for national group, histology (large cell; small non cleaved cell) and CNS disease.
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C
- Conditions
- B-Cell Lymphoma
- Being tested
- half cyclophosphamide, without COPADM3, mini CYVE, without 3 maintenance courses, LMB B, LMB C
- Keywords
- B-Cell Lymphoma
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
half cyclophosphamideDrug
without COPADM3Drug
mini CYVE, without 3 maintenance coursesDrug
LMB BDrug
LMB CDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard LMB B | Active comparator | Not described Receives: Drug: LMB B |
| LMB B without COPADM3 | Experimental | Not described Receives: Drug: without COPADM3 |
| LMB B with half cyclophosphamide | Experimental | Not described Receives: Drug: half cyclophosphamide |
| LMB B without COPADM3 and with half cyclophosphamide | Experimental | Not described Receives: Drug: half cyclophosphamide; Drug: without COPADM3 |
| LMB C standard | Active comparator | Not described Receives: Drug: LMB C |
| LMB C with mini CYVE and without 3 maintenance courses | Experimental | Not described Receives: Drug: mini CYVE, without 3 maintenance courses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)
Measured: 3 years
Secondary outcomes (2)
Survival
Measured: 3 years
long term toxicity
long term toxicity: cardiotoxicity, impaired fertility, secondary malignancy
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 1996
- Primary completionMay 2004
- Study completionMay 2011
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 B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Patte, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisMitchell S Cairo, MD, Principal investigator, Morgan Stanley Childrens Hospital of New York Presbyterian, Columbia UniversityMary Gerrard, MD, Principal investigator, Sheffield Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162656
- Sponsor's protocol ID
- FAB LMB96
- Status last verified
- Mar 2012
- First submitted
- 7 Sep 2005
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.
PubMed 30117142
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study
- ClinicalTrials.gov ID
- NCT00162656
- Acronym / sponsor ID
- FAB LMB96
- Conditions
- B-Cell Lymphoma
- Keywords
- B-Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- May 1996
- Primary completion
- May 2004 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Sep 2005 (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.
This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
Detailed description
Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89 therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both reduction and deletion. Randomization occurs following COPADM1 and is stratified for national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy III+LDH<2N; Murphy III+LDH>2N or Murphy IV).
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2 and is stratified for national group, histology (large cell; small non cleaved cell) and CNS disease.
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard LMB B | Active comparator | Drug: LMB B |
| LMB B without COPADM3 | Experimental | Drug: without COPADM3 |
| LMB B with half cyclophosphamide | Experimental | Drug: half cyclophosphamide |
| LMB B without COPADM3 and with half cyclophosphamide | Experimental | Drug: half cyclophosphamide, Drug: without COPADM3 |
| LMB C standard | Active comparator | Drug: LMB C |
| LMB C with mini CYVE and without 3 maintenance courses | Experimental | Drug: mini CYVE, without 3 maintenance courses |
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow > 5% L3 blasts.
- Pre treatment imaging studies adequate to document Murphy disease stage
- Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts)
- Patients should be available for a minimum follow up of 36 months
- Informed consent prior to study entry
Key exclusion criteria (6 listed)
- Anaplastic large cell Ki 1 positive lymphomas
- Previous chemotherapy.
- Congenital immunodeficiency
- Prior organ transplantation
- Previous malignancy of any type
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 |
|---|---|---|
| half cyclophosphamide | Drug | LMB B with half cyclophosphamide, LMB B without COPADM3 and with half cyclophosphamide |
| without COPADM3 | Drug | LMB B without COPADM3, LMB B without COPADM3 and with half cyclophosphamide |
| mini CYVE, without 3 maintenance courses | Drug | LMB C with mini CYVE and without 3 maintenance courses |
| LMB B | Drug | Standard LMB B |
| LMB C | Drug | LMB C standard |
Primary outcome
Event free survival
Time frame: 3 years
Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)
2 secondary outcomes
Survival
Time frame: 3 years
long term toxicity
Time frame: 10 years
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 28 Mar 2012.
- Derived from this study: PubMed 30117142Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.
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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.
Catherine Patte, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Mitchell S Cairo, MD principal investigator
Morgan Stanley Childrens Hospital of New York Presbyterian, Columbia University
Mary Gerrard, MD principal investigator
Sheffield Children's Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing half cyclophosphamide, without COPADM3 and mini CYVE, without 3 maintenance courses in people with B-Cell Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in 3 countries.
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 6 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 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France, United Kingdom. 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 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?
Event free survival (time frame: 3 years). 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 NCT00162656, 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 28 Mar 2012.