NORDIC LYMPHOMA GROUP NEWSLETTER JUNE 2007

 

Dear members of the NLG society,

 

This early summer Newsletter will give you some brief information on the present status of the organization and the study group activities.

 

NLG Study Centres: Since last Newsletter two more “NLG Study Centres” have been approved; Aalborg in Denmark (center number 104), and Luleå/Sunderbyn in Sweden (center number 411). A further application is just received and will probably be accepted soon, and further applications are of course welcome in the future. The total number of centers is now 26, which are listed here:

 

Denmark

101 Aarhus, Dept of Hematology 

102 Herlev, Dept of Hematology

103 Rigshospitalet, Dept of Hematology

104 Aalborg, Dept of Hematology

Finland

201 Helsinki, Dept of Oncology

202 Kuopio, Dept of Medicine

203 Oulu, Dept of Oncology and Radiotherapy

204 Tampere, Dept of Oncology

205 Turku, Dept of Oncology and Radiotherapy

 

Norway

301 Haukeland, Dept of Oncology

302 Radiumhopsitalet, Dept of Medical Oncology

303 St Olavs Hospital, Cancer dept.

304 Stavanger, Dept of Blood and Cancer diseases

305 Ullevål, Dept of Oncology

Sweden

401 Halmstad, Dept of Internal Medicine

402 Karolinska Huddinge, Hematology Center

403 Karolinska Solna, Center of Hematology

404 Lund, Dept of Oncology

405 Linköping, Dept of Oncology

406 Malmö, Depts of Oncology and Hematology

407 Sahlgrenska, Section of Hematology and coagulation

408 Sundsvall, Dept of Medicine

409 Umeå, Dept of Oncology

410 Uppsala, Dept of Oncology

411 Sunderbyn, Dept of Medicine

 

The activities, as reported on regular forms to the coordinating group, is fairly good, but there is certainly room for improvement. The possibility for the centers to apply for some financial support from NLG has so far not been used! I will remind all center representatives of this option, which e.g., may be to support some (limited) research nurse assistance if that has been shown impossible to arrange in respect to a certain study, and that is crucial for participation in that project.

 

Economy: For 2007, NLG was awarded 60,000 Euro from the Nordic Cancer Union, which was a 20% increase compared with 2005 and 2006. Based on the applications and stated needs from the working groups, the NLG coordinating group has decided to divide the money to the following projects:

CRY -04  9,000 Euro

PET-study  2,000 Euro

NLG T-101  3,000 Euro

NLG T-102  10,000 Euro

MCL 2 and 3  14,000 Euro

Hodgkin, early stage  2,000 Euro

Indolent, rituximab ± interferon  13,000 Euro

Nordic CNS lymphoma protocol 7,000 Euro

 

The applications process for 2008 is on-going.

 

The present sponsor agreement with the industry (a total of 60,000 Euro yearly) is running through this year. We are now in the process of approaching these and other potential sponsors for a new agreement for 2008-09. We warmly thank our present sponsors Roche (main sponsor), Amgen, Schering (now Bayer-Schering), Schering-Plough, Mundipharma and Wyeth.!

 

Plenary meeting 2007: This year the plenary meeting will be held in Lillehammer, Norway, and it will be a three days meeting October 25-27. See the preliminary agenda in this Newsletter! Working group meetings may be held at afternoon/evening October 24 or before the start of the meeting (11 a.m.) October 25. Guest lecturer this year is not yet settled. As an educational overview we have asked Lena Specht to give us her view on the use of radiotherapy for lymphomas today. As last year we also plan a session for discussion of unusual or difficult lymphoma cases, and again we especially encourage younger participants to contribute actively. All members of the working groups will have the possibility to participate, and we also guarantee at least one seat for every NLG Study Centre. The coordinating group members of every country (or the national lymphoma group) will be responsible for distribution of seats within their country. As usual our sponsors will also be welcome to send their representatives, although a “business meeting” will only be open for the NLG delegates.

Free paper session: This year we also invite all potential delegates to submit abstracts on any kind of on-going lymphoma research for a special session on the meeting! Please, send your abstract before August 31 to any of your national members of the NLG coordinating group. If your abstract is accepted we will of course also give your participation highest priority!

 

Short on on-going activities:

Low grade lymphoma

The work of the group has been focused on the randomized phase III trial comparing rituximab (4+4 infusions in standard doses) with the same antibody regimen in combination with interferon during 5+5 weeks (with start two weeks before rituximab) in patients with CD20+ indolent lymphomas. The accrual of the study on the 1st of April was 262 patients. After a DMBC recommendation more follicular lymphomas (FL) are to be included and also FL grade IIIa (now considered as an indolent lymphoma) are now eligible.  A total of 313 randomized patients are to be randomised. Estimated date of end of accrual: October 31st 2007. Several “spin-off projects” using samples from both the previous Nordic Phase II and the ongoing phase III trial, have been initiated; as gene expression profiling of fresh frozen lymphoma tissue and extended immunohistochemical studies and FISH on paraffin sections (also using tissuemicroarray tecniques).  Fc-receptorgenotyping using previous blood samples is performed and the results will be related to the response to therapy.  

A “follicular lymphoma working group” has been initiated including the above members and also pathologist from the four countries (Jan Delabie, Marja-Liisa Karjalainen-Lindsberg, Birgitta Sander and Christer Sundström). The focus of the group is biological markers and translational research. The group is represented in the International Lunenburg Lymphoma Biomarker Consortium (Eva Kimby + Birgitta Sander).

 

Large B-cell lymphoma

CRY-04 study: A Nordic phase 2 study for patients below 65 years with diffuse large B-cell lymphoma, IPI score 2-3: CHOEP-14 + rituximab, 6 courses, followed by high dose methotrexate, 1 course and high dose cytarabine, 1 course: The study has been open for inclusion in Norway, Sweden and Finland for more than two years and from 2006 in two centres in Denmark. So far, 100 patients have been included. The primary objective is to estimate the proportion of patients that are failure free at three years. Among the secondary objectives, we will investigate the incidence of CNS relapse and investigate molecular factors important for clinical outcome. Approximately 50 patients are included annually. So far the results are encouraging. We encourage colleagues in the Nordic lymphoma community to register eligible patients so that we can include 150 patients by the end of  June 2008. The study protocol can be found at our homepage www.nordic-lymphoma.org.

 

PET in DLBCL: A Nordic phase II study evaluating the response of treatment using 18-F PET for patients with stage IIB-IV with special emphasis on the prognostic significance of PET after one cycle of chemotherapy. Three centres in Denmark and one in Sweden, Finland and Norway each participate. We plan to include 100 patients. A significant impact of early-PET on patient outcome will in a subsequent study lead to change of therapy for PET positive patients and / or reduced length of therapy for PET negative patients. So far 30? patients have been included.

 

New studies: The working groups have been approached by both other Lymphoma groups and the Pharmaceutical industry concerning other studies. So far the Large Cell Group has not joined any of these studies. Presently, two follow up studies to the MInT study from the German Large Cell Lymphoma Group (FLYER, UNFOLDER) are being considered as well as a study for the elderly population with diffuse large B-cell lymphomas with adverse prognosis. The National Lymphoma Groups and study centres will be informed. A protocol meeting after summer vacation is proposed. In addition, a follow up study for the CRY-04 study and the PET study is being discussed.

 

Mantle-cell lymphoma

MCL2-Protocol: Only a few pathology reviews are missing. The data base is being finalised, and a paper is in preparation. Submission to ASH and publication August 2007. Final results to be presented at the Plenary Meeting.

MCL3: High-dose therapy with autologous stem cell support in first line treatment of mantle cell lymphoma – 90y-ibritumomab tiuxetan in combination with BEAM or BEAC to improve outcome for patients not in CR after induction treatment.

Ongoing, with a very good  accrual (~5 patients per month, presently 60 patients). The goal (150 patients) will be reached in less than two years.

 

T-cell lymphoma

NLG-T-01: Ongoing, almost 150 pts. included.

Updated feasibility, efficacy and time-related end-point results were presented as oral paper at ASH 2006 (Orlando). The toxicity profile was manageable and the cumulative response rate was high. Three-year survival 67% (95% CI: 56-75%):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


The NLG-T-01 will continue in Scandinavian countries until the international phase III trial (ACT-1 and ACT-2 trials, see below) will be activated, i.e. until Q3-4 2007. A trial-specific biobase is currently under construction to identify the tissue and other biosamples available at the different centers. A publication with the main study end-points is planned for the end of this year, when the study cohort will have a median follow-up of approximately 3 years.

 

ACT-trial (ACT-1 and ACT-2): To be launched 2007:

 

The international phase III trial, ACT-trial, is a result of a collaboration between the NLG and the German Study Group on Aggressive Non-Hodgkin Lymphomas (DSHNHL). The protocol has been finalized and is now at the main sponsors’ national medical authorities for approval. The ACT-1 trial is coordinated by the NLG and the ACT-2 trial by the DSHNHL. The ACT-1 trial randomizes pts up to 65 yrs between CHOP-14x6 + autotransplant and CHOP-14 + alemtuzumab x6 + autotransplant. The antibody alemtuzumab is given at each CHOP course as 30 mg s.c. day 1 and 2 (cumulative 60mg). The ACT-2 trial is for patients above 65 yrs of age, it has an identical induction schedule, but no autologous transplant consolidation. So far, over 100 centers from 17 different countries have agreed to join the studies. This includes centers from most European countries, Russia, Israel and Australia.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Auto= autologous transplant

Obs= observation without further therapy

 

CNS lymphoma

Status of the Nordic PCNSL study  (EudraCT No. 2006-004772-12): A Norwegian patient has been included in the study as the first patient

Present activities in the working group: treatment strategies in progressive/relapsed PCNSL. HD chemotherapy with stem cell rescue might be an option in younger patients.

 

Hodgkin´s lymphoma

The Hodgkin group is currently evaluating the Nordic phase II study on early stage HL. Data has been reported from Norway and Sweden. An abstract will be sent in to the International Hodgkin Lymphoma meeting in Cologne, November 2007. The group is also participating in discussions of a transatlantic study on advanced HL. The study will evaluate early FDG-PET for response and escalate or de-escalate therapy depending on PET result. The study will be academic and will run in Europe and the US. Hopefully it will start by the end of 2007.

 

The next “Newsletter” will be the programme for the plenary meeting in Lillehammer, and will be distributed a couple of weeks before the meeting.

 

With best regards from the coordinating group

 

Mikael Eriksson

chairman, NLG


NLG Plenary meeting Lillehammer 2007:

Time: October 25 – 27, Place: Radisson SAS Lillehammer Hotel (www.lillehammerhotel.no)

 

Preliminary agenda:

 

Thursday October 25

 

Morning   Working Group meetings (may be started at Wednesday afternoon/evening)

11.00-12.00 Registration, check in

12.00-13.00 Lunch

13.00-13.15 Meeting opens (HH, ME)

13.15-13.45 Working group: Large B-cell lymphoma

13.45-14.15 Working group: Indolent lymphoma

14.15-14.45 Working group: Mantle cell lymphoma

14.45-15.15 Working group: T-cell lymphoma

15.15-15.45 Coffee/Tea

15.45-16.15 Working group: CNS lymphoma

16.15-16.45 Working group: Hodgkin’s lymphoma

16.45-17.00 Leg stretch-brake

17.00-18.00 Business meeting (closed for industry)

18.30            Refreshments

19.00            Dinner

 

Friday October 26

 

08.00-09.00 Breakfast

09.00-10.00 National lymphoma registries – how far have we reached?

                     Presentation by the Staging/Epidemiology working group

10.00-10.30 Working group: Pathology

10.30-11.00 Coffee/Tea

11.00-12.30 Guest lecturer, to be announced

12.30-13.30 Lunch

13.30-16.30 Excursion in the surroundings; coffee/tea included

16.30-18.00 Free paper presentation on on-going lymphoma research

18.30            Refreshments

19.00            Dinner; social evening with music/dance??

 

Saturday October 27

 

08.00-09.00 Breakfast

09.00-10.30 “Interesting cases”-session

10.30-11.00 Coffee/Tea

11.00-11.45 Educational lecture: Role of radiotherapy in lymphoma today, Lena Specht

11.45-12.30 Summing-up session, change of chairman, and closing of the meeting