Samples
Pre-treatment samples are available for all studies listed, with additional longitudinal samples available for some studies.
Stored material includes cryopreserved mononuclear cells, plasma, serum and germline DNA obtained from saliva. The table summarises the studies and patient cohorts for which samples are available, together with an indication of how many samples from each study are available at different time points.
| Treatment status | Clinical study (trial recruitment) | Therapy regimen |
|---|---|---|
| Treatment-naive | AdMIRe (215) | FCR, FCMR |
| ARCTIC (200) | FCR, FCM(mini)R | |
| CLEAR (78) | Metronidazole, clarithromycin, ciprofloxacin and lansoprazole | |
| COSMIC (62) | Standard Of-FC | |
| CYCLLE (5) | Cyclosporin A | |
| FLAIR (1507) | FCR Ibrutinib Ibrutinib + rituximab Ibrutinib + venetoclax |
|
| ICiCLLe (40) | Ibrutinib | |
| RESPECT (5) | Lenalidomide | |
| RIAltO (521) | Chlorambucil + ofatumumab Bendamustine + ofatumumab Idelalisib + C/B + ofatumumab |
|
| Relapsed/refractory | CLARITY (3) | Ibrutinib + venetoclax |
| CLL210 (64) | Alemtuzumab + dexamethasone + lenalidomide | |
| ICiCLLe (40) | Ibrutinib | |
| TP53 aberration | CLL206*(32) | Alemtuzumab + methylprednisolone |
| CLL210 (64) | Alemtuzumab + dexamethasone + lenalidomide | |
| FLAIR TP53 disruption cohort | Ibrutinib Ibrutinib + venetoclax |
|
| Transformed disease therapy | CHOP-OR (43) | Of- Cyclophosmamide+ Doxorubicin +Vincristine+ Prednisolone |
| Consolidation therapy | GALACTIC (24) | Obinotuzimab No treatment |
| STATIC | Continuous compared to intermittent strategies using ibrutinib (BTK inhibitor) |
*Not collected to GCP standards as preceded GCP Lab
| Trial | Timepoint | Samples Type (no. of patients samples) |
|---|---|---|
| AdMIRe | Baseline |
|
| Response assessment (3 months post treatment) | Bone marrow MNCs (97) | |
| Disease Progression | PBMCs and plasma (49) | |
| ARCTIC | Baseline | • PBMCs and plasma (166) • Serum (166) • Bone marrow MNCs (if lymphs<10 x109/l) • Bone marrow MNCs (if lymphs<10 x109/l) (11) • Germline (saliva) DNA (162) |
| Response assessment (3 months post treatment) | Bone marrow MNCs (95) | |
| Disease Progression | • PBMCs and plasma (49) | |
| CLEAR | Baseline | • PBMCs and plasma (63) • Serum (63) • Saliva (germline DNA) (63) |
| Evaluation (6 months after starting trial) | • PBMCs and plasma (49) • Serum (49) |
|
| COSMIC | Baseline | • PBMCs and plasma (50) • Serum (49) • Bone marrow MNCs/pellet (if lymphs<10 x109/l) (10) • Germline (saliva) DNA (50) |
| Response assessment (3 months post treatment) | • Bone marrow aspirate (cell pellet) (29) | |
| Disease Progression | • PBMCs and plasma (18) | |
| CyCLLE | Baseline | • PBMCs and plasma (5) • Serum (5) • Germline (saliva) DNA (5) |
| FLAIR | Baseline | • PBMCs and plasma (896) • Serum (864) • Bone marrow MNCs (if lymphs<10 x109/l) (63) • Germline (saliva) DNA (883) |
| Response assessment (3 months post treatment) | • Bone marrow aspirate (cell pellet) (538) | |
| Disease Progression | • PBMCs and plasma (85) | |
| ICiCLLe | Baseline | • PBMCs and plasma (21) • Serum (21) • Germline (saliva) DNA (20) |
| 1 week | • PBMCs and plasma (19) • Serum (19) |
|
| 1 month | • PBMCs and plasma (17) • Serum (17) |
|
| 6 months | • PBMCs and plasma (11) • Serum (11) |
|
| Disease Progression | • PBMCs and plasma (1) • Serum (1) |
|
| RESPeCT | Baseline | • PBMCs and plasma (5) • Serum (5) • Bone marrow MNCs (if lymphs<10 x109/l) (5) • Saliva (germline DNA) (5) |
| 1 week | • PBMCs and plasma (1) • Serum (1) |
|
| 1 month | • PBMCs and plasma (1) • Serum (1) |
|
| 3 month | • PBMCs and plasma (1) • Serum (1) |
|
| 6 month | • PBMCs and plasma (1) • Serum (1) |
|
| RIAltO | Baseline | • PBMCs and plasma (459) • Serum (452) • Germline (saliva) DNA (450) |
| 6 months post treatment | • PBMCs and plasma (226) • Serum (225) |
|
| 12 months post treatment | • PBMCs and plasma (210) • Serum (209) |
|
| 18 months post treatment | • PBMCs and plasma (181) • Serum (182) |
|
| 24 months post treatment | • PBMCs and plasma (132) • Serum (130) |
|
| 30 months post treatment | • PBMCs and plasma (132) • Serum (132) |
|
| 36 months post treatment | • PBMCs and plasma (89) • Serum (88) |
|
| 42 months post treatment | • PBMCs and plasma (74) • Serum (74) |
|
| Disease Progression | • PBMCs and plasma (144) • Serum (141) |
|
| CLARITY | Baseline | • PBMCs and plasma (3) • Serum (3) • Germline (saliva) DNA (2) |
| 8 week | • PBMCs and plasma (3) • Serum (3) |
|
| 13 week | • PBMCs and plasma (3) • Serum (3) |
|
| 14 week | • PBMCs and plasma (3) • Serum (3) |
|
| 15 week | • PBMCs and plasma (2) • Serum (2) |
|
| CLL210 | Baseline | • PBMCs and plasma (64) • Serum (64) • Germline (saliva) DNA (60) |
| Week 1 day 1 | • PBMCs and plasma (55) • Serum (56) |
|
| Week 1 day 3 | • PBMCs and plasma (54) • Serum (54) |
|
| Week 3 day 1 | • PBMCs and plasma) (53) • Serum (53) |
|
| Week 3 day 3 | • PBMCs and plasma (49) • Serum (49) |
|
| Week 5 day 1 (small cohort) | • PBMCs and plasma (12) • Serum (12) |
|
| Week 5 day 3 (small cohort) | • PBMCs and plasma (12) • Serum (12) |
|
| Week 11 | • Serum (42) | |
| Week 15 | • Serum (39) | |
| Week 19 | • Serum (32) | |
| Week 23 | • PBMCs and plasma (36) • Serum (36) |
|
| Disease Relapse | • PBMCs and plasma (13) • Serum (14) |
|
| CHOP-OR | Baseline | • PBMCs and plasma (27) • Serum (27) • Germline (saliva) DNA (27) |
| Disease Progression | • PBMCs and plasma (2) | |
| GALACTIC | Baseline | • PBMCs and plasma (22) • Serum (22) • Bone marrow MNCs (if lymphs<10 x109/l) (21) • Germline (saliva) DNA (22) |
| Response assessment (3 months post treatment) | • Bone marrow aspirate (cell pellet) (8) | |
| Disease Progression | • PBMCs and plasma (8) |
Incoming samples
Samples are collected, transported, processed and stored in accordance with Good Clinical Practice (GCP) standards with all aspects covered by SOPs. Barcoded sample collection kits containing a temperature recorder are assembled and dispatched to local sites. Anticoagulated blood, clotted blood and saliva samples are transported to the biobank within 24 hours, logged into the Laboratory Information Management System (LIMS), processed into mononuclear cells, plasma, serum and germline DNA, and frozen in aliquots at -80degrees C in fully alarmed freezers with 24h callout in the event of failure.
Outgoing samples
Samples approved for research projects are collated and dispatched by courier on dry ice. When research projects are completed, material surplus to requirement is returned to the biobank.
Quality assurance
To ensure that samples are of the highest possible quality, excursions to the transit time (<24h) are recorded as quality incidents and the temperature range of a percentage of samples during transport are also logged. All sample processing is performed in accordance with detailed SOPs. All freezers are alarmed with 24-hour callout to mitigate the risk of equipment failure.
Quality assurance is provided not only by external inspections from the HTA and MHRA but also regular internal audits to confirm that all documentation is present and correct and that the number and location of aliquots corresponds with the information recorded in LIMS. The audit process includes spot checks on samples randomly selected from the freezer and longitudinal tracking of randomly selected sample entry logs in LIMS.