High Grade Lymphoma. Trial name & Treatment Key entry criteria Open Sites. Relapsed/Refractory

Transcription

1 DISEASE or High Grade Lymphoma DLBCL INCA = Inotuzumab Ozogamicin (INO) + Rituximab + CVP v Gemcitabine + Rituximab + CVP following a steroid pre-phase of pred 60mg x 7 days Second Line Trial name & Treatment Key entry criteria Open Sites IELSG-37 =R-chemotherapy, followed by PET/CT. Those with PR/CR will be randomized to consolidation RT or observation LEGEND =A randomised phase II study comparing LEnalidomide plus rituximab, GEmcitabine and methylprednisolone (LR-GEM) to rituximab, gemcitabine, methylprednisolone and cisplatin (R-GEM-P) in second-line treatment of Unsuitable for anthracycline-containing chemotherapy due to impaired cardiac function defined by an ejection fraction of 50% OR Left ventricle ejection fraction >50% but in the presence of significant comorbidities (diabetes mellitus, hypertension or ischaemic heart disease) precluding anthracycline-containing chemotherapy as determined by treating physician. No stage 1a (non-bulky) Untreated primary mediastinal DLBCL, no extra nodal disease Histologically proven CD20 +DLBCL lymphoma Stage I (with bulk>10 cm), Stage II, III or IV One prior chemotherapy regimen which contained rituximab and anthracycline, unless contraindicated No CNS or leptomeningeal involvement with lymphoma No treatment for lymphoma within 4 CoC

2 Primary CNS Secondary CNS Burkitt s T-NHL (PTCL,ALCL,AITL,ITL) Diffuse Large B-cell lymphoma (DLBCL) weeks of commencing trial therapy Relapsed/ Refractory TORCH-oral agent mtorc 1 & 2 inhibitor, 50mg BD until progression/toxicity (TAP) Small cohort to receive Rituximab in combo. Phase 2. Relapsing after at least 1 course anti CD20 antibody regime, high grade transformation from low grade is permitted. SADAL= Selinexor, (an orally Documented evidence disease bioavailable, selective inhibitor of progression, not candidates for auto nuclear export (SINE)) PBSCT, 2-4 lines previous therapy +dexamethasone- Commercial Observational MAPLE- Sample collection only Newly Diagnosed Wirral TIER- A Phase I/II Study of Relapsed or refractory PCNSL according to Thiotepa, Ifosphamide, Etoposide the following definition: and Rituximab for the treatment of relapsed or refractory primary Front line Relapse/ Refractory central nervous system lymphoma CHEMO-T = 6 x CHOP vs 4 x GEM- P Evidence of disease recurrence following PR/CRu/CR or failure to achieve PR following: One or two prior chemotherapy regimen(s), of which at least one regimen contained high-dose methotrexate at a dose of >1g/m2. Newly diagnosed

3 Relapse/ Refractory ROMICAR= Romidepsin (HDAC inhinitor) & Carfilzomib (proteasome inhibitor), determining MTD & activity (TAP) Failed at least 1 prior therapy

4 DISEASE Follicular Mantle Marginal Zone Waldenstroms/ LPL or Relapsed/ Refractory Observational Relapsed/ Refractory Relapsed/ Refractory Low Grade Lymphoma Trial name & Treatment Key entry criteria Open Sites MCL Biobank = blood and saliva samples at diagnosis Newly diagnosed, pre treatment Wirral SKIN LYMPHOMA Front line PROCLIPI = diagnosis, annual and disease progression time points data collection only (may include tissue at a later date) Newly diagnosed Mycosis fungoides or Sezary syndrome Currently Suspended until further notice NK- cell Sample collection only Any NK-lineage neoplasm

5 DISEASE or CLL Front line First-line treatment, not fit for R- FC Trial name & Treatment Key entry criteria Open Sites FLAIR- A trial of ibrutinib with rituximab for CLL CALIBRE- continuous idelalisib till disease progression CALIBRE- continuous idelalisib till disease progression ICICLLE continuous Ibrutinib + 6 cycles Obinutuzumab COSMIC = standard Ofa + FC/B v High dose Ofa +FC/B RIALtO = Ofatumumab + Chlorambucil v Ofatumumab + Bendamustine with a randomization on both arms to receive either Idelalisib or placebo, as well as maintenance Idela/placebo for a maximum of 3 years post induction commencement. RECRUITMENT HALTED 11/3/16 Newly diagnosed, fit for R-FC Requiring therapy, stage A,B or C RECRUITMENT HALTED 11/3/16 Failure to respond to purine analog alone or in combination with chemo, relapse within 6 months of the above, or relapse at any time post FCR or BR, or 17p deleted patients who ve failed at least 1 previous therapy RECRUITMENT HALTED 11/3/16 Failure to respond to chemo, or relapse within 6 months of responding to chemo, relapse any time after FCR/BR or 17p deleted who ve failed at least 1 previous therapy. At least 1 prior therapy, fit for F/B, no relapse within 6 months of F/FC/B, no relapse within 12 months FCR/RB, Wirral Warrington COC

6 Ofatumumab naïve. ACE-CL-006 = ACP-196 V Ibrutinib 17p deletion or 11q deletion, at least 1 prior therapy GALACTIC - 12 weeks of either GA-101 Obinotuzumab or not. PR/CRi/CR 3-12 months post treatment, maximum 3 prior therapies If you have any patients you would consider suitable for any of the studies, you can contact the following research teams for further information; Aintree University Hospital- Leigh Pauls; leigh.pauls@aintree.nhs.uk - Elizabeth Dale; Elizabeth.dale@rlbuht.nhs.uk WUTH- Ya-Wen.Huang; ya-wen.huang@nhs.net Southport and Ormskirk- Teresa Monahan teresa.monahan@nhs.net St Helens and Knowsley- Rachel Cassidy rachel.cassidy@sthk.nhs.uk Countess of Chester- Janet Spriggs j.spriggs@nhs.net.