Lymphoblastic LymphomaPhase 2NCT00195871
Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma
A Phase 2 study testing Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide and hematopoietic stem cell allograft in people with Lymphoblastic Lymphoma, run by Centre Henri Becquerel at 19 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Lymphoblastic Lymphoma
- What is being tested?
- Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide and hematopoietic stem cell allograft
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Feb 2004to Dec 2015
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with lymphoblastic lymphoma.
- Aged from 18 to 59 years.
- Medullary blasts rate less than 20%
- Non previously treated
- With or without central nervous system or meningeal involvement.
- No contra-indication to anthracyclines.
Show all 10Show fewer
- No contra-indication to intensive treatments
- Negative HIV serology test
- Negative pregnancy test for all female patients of childbearing potential.
- Able to be regularly followed up.
Who cannot join
- Evolutive cancer with the exception of non melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
- Prior treatment with chemotherapy.
- Lymphoblastic Transformation of chronic myeloid leukaemia
- Patient unable to be regularly followed-up.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
France17 sites
C H U D'Angers
Angers, 49033
Centre Hospitalier de La Region Annecienne
Annecy, 74011
Chu de Grenoble
Grenoble, 38043
Centre Hospitalier de Lens
Lens, 62300
Edouard Herriot Hospital
Lyon, 69437
Pierre Benite Hospital
Lyon, 69495
Institut Paoli Calmettes
Marseille, 13273
Saint-Louis Hospital
Paris, 75000
La Pitie Salpetriere Hospital
Paris, 75013
Cochin Hospital
Paris, 75014
Marechal Joffre Hospital
Perpignan, 66046
Centre Hospitalier de Poitiers
Poitiers, 86000
Chu de Reims Robert Debre Hospital
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
Institut de Cancerologie de La Loire
Saint-Priest-en-Jarez, 42271
Bretonneau Hospital
Tours, 37044
Chu de Brabois
Vandœuvre-lès-Nancy, 54511
Belgium2 sites
Chr de La Citadelle
Liège, 4000
Cliniques Universitaires U C L de Mont Godinne
Yvoir, 5530
About this study
Official title: A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).
The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.
Read the detailed description
Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts. Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the various clinical studies, have shown a best efficacy of ALL type treatments(in terms of overall survival and disease free survival). These treatments are based on an induction phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs after consolidation (delayed intensification). The prognostic factors of ALL are now better defined, determining risk groups. According to these prognostic indicators, the allograft could be proposed in first complete remission. Indicators are biological (hyperleukocytosis, chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central nervous system involvement), evolutive (salvage therapy needed to obtain complete remission), consideration of early response (cortico-sensibility and chemo-sensibility) and molecular responses (residual disease). On the other hand, the prognostic factors of LL are not well known. This study should permit to better define them. So the prognostic indicators of ALL, in this study, will be decisional for the indication of allograft. This treatment is based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).
- Conditions
- Lymphoblastic Lymphoma
- Being tested
- Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide, hematopoietic stem cell allograft
- Keywords
- Non-Hodgkin, Lymphoma, Lymphoblastic
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposideDrug
Also called nono
coventional dosages
hematopoietic stem cell allograftProcedure or surgery
conventional procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: 2 y
Secondary outcomes (1)
Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities.
Measured: 2 y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionJun 2014 (estimated)
- Study completionDec 2015 (estimated)
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 Lymphoblastic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Lepretre, Centre Henri Becquerel
- Investigators
- Stephane Lepretre, MD, Study chair, Centre Henri Becquerel, Rouen, FranceHervé Dombret, MD, Principal investigator, Saint-Louis Hospital, Paris, FranceNorbert Ifrah, MD, Principal investigator, Centre Hospitalier Universitaire d'Angers, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195871
- Sponsor's protocol ID
- LL03
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Gouill S, Lepretre S, Briere J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4. doi: 10.1038/sj.leu.2403095.
PubMed 14576732
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).
- ClinicalTrials.gov ID
- NCT00195871
- Acronym / sponsor ID
- LL03
- Conditions
- Lymphoblastic Lymphoma
- Keywords
- Non-Hodgkin, Lymphoma, Lymphoblastic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 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.
The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.
Detailed description
Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts. Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the various clinical studies, have shown a best efficacy of ALL type treatments(in terms of overall survival and disease free survival). These treatments are based on an induction phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs after consolidation (delayed intensification). The prognostic factors of ALL are now better defined, determining risk groups. According to these prognostic indicators, the allograft could be proposed in first complete remission. Indicators are biological (hyperleukocytosis, chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central nervous system involvement), evolutive (salvage therapy needed to obtain complete remission), consideration of early response (cortico-sensibility and chemo-sensibility) and molecular responses (residual disease). On the other hand, the prognostic factors of LL are not well known. This study should permit to better define them. So the prognostic indicators of ALL, in this study, will be decisional for the indication of allograft. This treatment is based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient with lymphoblastic lymphoma.
- Aged from 18 to 59 years.
- Medullary blasts rate less than 20%
- Non previously treated
- With or without central nervous system or meningeal involvement.
Key exclusion criteria (4 listed)
- Evolutive cancer with the exception of non melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
- Prior treatment with chemotherapy.
- Lymphoblastic Transformation of chronic myeloid leukaemia
- Patient unable to be regularly followed-up.
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 |
|---|---|---|
| Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposideAlso: nonocoventional dosages | Drug | – |
| hematopoietic stem cell allograftconventional procedures | Procedure or surgery | – |
Primary outcome
Event free survival
Time frame: 2 y
1 secondary outcome
Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities.
Time frame: 2 y
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Background: PubMed 14576732Le Gouill S, Lepretre S, Briere J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4. doi: 10.1038/sj.leu.2403095.
- Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French)Link provided by the sponsor.
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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.
Stephane Lepretre, MD study chair
Centre Henri Becquerel, Rouen, France
Hervé Dombret, MD principal investigator
Saint-Louis Hospital, Paris, France
Norbert Ifrah, MD principal investigator
Centre Hospitalier Universitaire d'Angers, FRANCE
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide and hematopoietic stem cell allograft in people with Lymphoblastic Lymphoma, run by Centre Henri Becquerel at 19 sites in 2 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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Belgium. 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?
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: 2 y). 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 NCT00195871, 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 7 Nov 2013.