Table 4.
Treatment Emergent AIC Cases
| Patient 1 | Patient 2 | Patient 3* | Patient 4 | Patient 5 | Patient 6 | |
|---|---|---|---|---|---|---|
| Age at study entry, Gender | 50’s M | 70’s F | 60’s M | 70’s M | 70’s M | 70’s F |
| Number of prior CLL Treatments | 5 | 0 | 3 | 6 | 2 | 0 |
| Rai Stage | IV | I | II | IV | I | IV |
| Complex Karyotype | Y | N | Y | Y | Y | N |
| IGHV mutational status | mutated | mutated | unmutated | unknown | unmutated | unmutated |
| FISH panel abnormalities | BCL6 (3q27) CMYC (8q24) TP53 (17p13·1) D13S319(13q14·3) |
D12Z3 (12cen) | D13S319(13q14·3) ATM (11q22·3) |
none | D13S319(13q14·3) TP53 (17p13·1) |
D13S319(13q14·3) |
| AIC prior to ibrutinib | none | none | AIHA | AIHA | AIHA | ITP |
| AIC therapies prior to ibrutinib | n/a | n/a | Prednisone, IVIG, Rituximab, Dexamethsone, Aranesp | Rituximab, oral cyclophosphamide, mycophenolate mofetil, IVIG, prednisone, cyclosporine | Prednisone, IVIG | None |
| On an AIC therapy when starting ibrutinib | n/a | n/a | No | Yes, Prednisone 10mg | Yes, Prednisone 10mg | n/a |
| Treatment emergent AIC type | New AIHA | New AIHA | Relapsed AIHA | Relapsed AIHA | New ITP | Relapsed ITP |
| AIC therapy received | Prednisone, IVIG | IVIG | IVIG | Prednisone | Prednisone | Prednisone, Dexamethasone |
| AIC controlled | Yes | Yes | Yes | No | Yes | No |
| On ibrutinib at last follow up | No | Yes | Yes | No | Yes | No |
| Patient outcome | Died from infection | Alive and well | Alive and well | Stopped ibrutinib due need for steroids and infections, died from infection | Alive and well | Discontinued ibrutinib due to rash |
Characteristics are at time of ibrutinib initiation unless otherwise specified. Patient 3 is the only patient who received concomitant treatment with ofatumumab.
Developed autoimmune granulocytopenia which was treated with cyclosporine.