Apr 9, 2010 - Haematology Torino and Rome. Second International workshop ... >No concomitant cardiac, liver, lung or renal disease. >HIV negativity, HCV ...
Second International workshop on Interim-PET in Lymphoma April 8th-9th Menton (France)
Current Studies with Interim-PET Non-Hodgkin Lymphoma The Intergruppo Italiano Linfomi study
Dr Umberto Vitolo – Dr Maurizio Martelli Haematology Torino and Rome
Phase III randomized, multicenter study in high-risk (IPI2-3) DLBCL young patients. Dose-dense chemotherapy + Rituximab +/- intensified and high dose chemoimmunotherapy with ASCT. Study ID: IIL-DLCL04. INCLUSION CRITERIA
Diffuse Large B-Cell Lymphoma CD20+ or Follicular grade IIIb Age 18-60 Advanced stage II, stage III and stage IV with at least 2aa-IPI risk factors Age-adjusted IPI 2 or 3 Intermediate-High or High Risk No concomitant cardiac, liver, lung or renal disease HIV negativity, HCV negativity or without active replication, HBsAg – Centralized pathological review
Phase III randomized, multicenter study in high-risk (IPI2-3) DLBCL young patients. Dose-dense chemotherapy + Rituximab +/- intensified and high dose chemoimmunotherapy with ASCT. Study ID: IIL-DLCL04.
R R A N D O M I Z A T I O N
NR
Off study
E
188 Pts
R-MegaCHOP14 x 4
S
CR/PR R-CHOP14 x 4
T
R-MAD x 2 + BEAM + ASCT
A
188 Pts
R-MegaCHOP14 x 4 R-CHOP14 x 4
G
R-MegaCHOP14 x 2 CR/PR R-CHOP14 x 4
I N
NR
Off study
G
*Patients at risk of CNS recurrence (SIE guidelines 2006): IT Mtx 4 or 6 doses
R-Dose Dense + HDC supplemented with Rituximab + ASCT
R MegaCEOP14 x 4 H R R R R D Cmonths0 1
MAD R
2
MAD R
3
BEAM
P B S C
A S C T 4
5
R = Rituximab Induction chemotherapy Months 1 and 2
Intensified chemotherapy MAD (HD-ARAC + Mitoxantrone x 3 days) Months 3 and 4
R-MEGACEOP14
R-MAD
R 375 mg/m2 d 1 Epi 110 mg/m2 d 3 Ctx 1200 mg/m2 d 3 Vcr 1.4 mg/m2 d 3 Pdn 40 mg/m2 dd 1 5 G-CSF 5 mcg/kg dd 5 12
Mito 8 mg/m2 dd 1 3 2 ARA-C 2 g/m /12h dd 1 3 2 Dex 4 mg/m /12h dd 1 3 2 R 375 mg/m d 4 and d -1PBSC G-CSF 5 µg/Kg d 4
High dose chemotherapy BEAM + ASCT Month 5
+/- RT-IF to bulky disease or residual mass
Vitolo U, et al. Haematologica 2009; 94: 1250-58
R-HDC: June 2002 – December 2005 94 patients
4-yr OS 80% (95%CI: 71.6%-88.4%)
4-yr FFS 73% (95%CI: 63.5%-82.5%)
OBJECTIVE Primary: To detect an increase of 15% in the probability of FFS at 2 years in favour of R-CHOP/R-MegaCHOP+ASCT arm compared with R-CHOP/R-MegaCHOP Secondary: To evaluate OS of R-CHOP/R-MegaCHOP + ASCT To evaluate 2-yr FFS of R-CHOP compared with R-MegaCHOP To evaluate 2-yr FFS of four randomized arms (exploratory analysis)
STATISTICAL METHODS Multifactorial 2 x 2 study, four arms randomized, open label, multicenter, phase III study With a two-sided α error of 0.05 and a β error of 0.20 and assuming a 50% 2year FFS in the R-CHOP/R-MegaCHOP arm versus an expected 65% in the ASCT arm, this design required the randomization of 170 patients per arm (ASCT vs no ASCT). Planned sample size including drop out: 376 patients (94 in each arm) Time of recruitment: 4 years in 50 Italian Centres
Optional ancillary trial interim PET in IIL-DLCL04 Staging CT scan and 18-FDG-PET R-CHOP14/R-MegaCHOP14 X 2 Early response evaluation 18-FDG-PET R-CHOP14/R-MegaCHOP14 X 2 RESPONSE EVALUATION
NO CHANGE OF TREATMENT BASED ON EARLY 18-FDGPET RESULTS
Interim response evaluation by CT scan
R-MADx 2
R-CHOP14/RMegaCHOP14
18-FDG-PET pre ASCT BEAM-ASCT
Final restaging CT scan and 18-FDG-PET
MANDATORY
A randomized phase III study in young patients with untreated high risk (aaIPI 2-3) Diffuse Large B-Cell Lymphoma. Study ID: IIL-DLCL04. 400 350
Enrollement March 2010: 366/376
300 250 200
Actual Enrollment
150 100
Expected Enrollment
50 0
mar-10
dic-09
set-09
giu-09
mar-09
dic-08
set-08
giu-08
mar-08
dic-07
set-07
giu-07
mar-07
dec-06
set-06
giu-06
mar-06
Enrollement in the ancillary trial interim and final PET: 142
PRELIMINARY CONCLUSION Dose dense chemoimmunotherapy ± HDC and ASCT is feasible and safe in a large multicenter cooperative study The overall results of the interim analysis show a high CR rate and a good 2-year PFS in high-risk DLBCL young patients The study will give new insights on the role of Rituximab-high-dose chemotherapy and ASCT compared to standard dose dense chemoimmunotherapy (R-CHOP14/R-MegaCHOP14) The ancillary interim-PET study is a prospective study with no change of therapy based on PET results and the results will be helpful to clarify the role of interim PET in DLBCL treated with dosedense chemoimmunotherapy
published in Leukemia Lymphoma. ⢠Would the next step be :Imaging in ... lymphoma subtypes (FL,MCL,T-lymphoma ). 3. Identify key area of research in ...
FDG-PET after 2 cycles appears highly predictive, particularly for ... features (bulk, 3+ sites). ⢠All prognostic ... Assumptions: â 75% PET-negative after 2 ABVD.
Staging and risk assessment of marginal zone lymphoma: ââ¦The value of positron emission ... MALT originating from the left lacrimal gland. PET-CT in MALT ...
if + (scores 4-5) or equivocal (score 3) then PET after 2 ABVD cycle. ⢠N=199 HL. 54 I-IIA .... Baseline MTV predictive of PFS and OS although tumor bulk was not.
Apr 8, 2010 - Positivity/Reference background. â¢Nearby background. â¢Mediastinal blood pool ... On which curve is this patient? Significance of minimal ...
Therapy ABVD or EBVD x 6 ± consolidation or IF radiotherapy. Visual assessment: ... LYMPHOMA. 44 HIV-related HL patients enrolled in 9 European centers.
3rd International Workshop on Interim PET in Lymphoma. Menton, September 27, 2011. Poster Discussion. Poster discussion. NHL. Ulrich Dührsen. Department ...
The five-point visual assessment is applied as proposed at the Deauville consensus meeting. ⢠A cohort of ABVD-treated advanced-stage HL patients has been ...
Various Rent-A-Car Companies can be found in the airport such as: Ada, Avis, Budget, Europcar, Hertz,. National Citer and Sixt. ⢠13 connections by regular bus ...
A 110 - Mounier N, Bower M, Spina M, Besson C, Schiantarelli C, Re A Bonnet F ..... Medicine Unit, Ospedale Policlinico, Padova; (7) Nuclear Medicine Unit, Ospedale La ...... Results: The average (median) time per scan upload and download.
Apr 8, 2010 - PET-positive after two courses of. ABVD and comparison of RT on prior bulk versus no RT in PET-negative patients at the end of chemotherapy.
Second international workshop on interim-PET in lymphoma. Menton (France), Palais de l'Europe, April 8-9th, 2010. Under the auspices of GELA, IIL, EORTC, ...
Sep 25, 2011 - lymphoma, new radiotracers and new imaging modalities. ⢠Evolving drugs: the era of targeted therapy could change the way we use PET ...
However, need for additional markers to identify curable from refractory/fatal patients? Cured. Fatal. Need to improve IPI. ⢠Biomarkers with prognostic relevance.
