Table 1.
Patient number | Trial start | Trial stop | cGVHD organs | Immunosuppression before trial | Immunosuppression at conclusion of the study | cGVHD score before start of the trial | cGVHD score at conclusion of the study | Comments |
---|---|---|---|---|---|---|---|---|
1 | 10/16/12 | 4/10/13 | Steroid refractory ophthalmic GVHD, mouth | Cyclosporine ophthalmic drop | Cyclosporine ophthalmic drop | Eyes 3 | Eyes 1 | Restarted on bortezomib 6 mo after the completion of the study due to relapse of cGVHD. |
Mouth 1 | Mouth 0 | |||||||
2 | 11/20/12 | 1/15/13 | Eyes, mouth, skin | Mycophenolate 100 mg twice daily, tacrolimus 1 mg daily, sirolimus 1 mg twice daily, prednisone 20 mg alternating with 40 mg | Mycophenolate 100 mg twice daily, tacrolimus 1 mg daily, sirolimus 1 mg twice daily, prednisone 20 mg alternating with 40 mg | Mouth 3 | Mouth 3 | Early withdrawal due to mouth sores. |
Joints 3 | Joints 3 | |||||||
Skin 2 | Skin 2 | |||||||
3 | 01/14/13 | 05/07/13 | Skin, mouth, eyes, GI, lungs, joints, and fascia | Mycophenolate 1000 mg twice daily and prednisone 40 mg qod | Mycophenolate 1000 mg twice daily and prednisone 40 mg qod | 2 for all organs involved | 2 for all organs involved | No significant response was observed |
4 | 03/18/13 | 08/27/13 | Skin, GI, mouth, and joint | Tacrolimus 1.5 mg twice daily, mycophenolate 1 g twice daily, prednisone 40 mg/day | Tacrolimus 1.5 mg twice daily, Mycophenolate 1 g twice daily, prednisone 30 mg/day | Skin 3 | Skin 2 | Significant healing of the ulcerated skin and mild softening/ decrease in pigmentation. Improved swallowing |
GI 2 | GI 1 | |||||||
Mouth 3 | Mouth 2 | |||||||
Joint 3 | Joint 2 | |||||||
5 | 06/25/13 | 12/10/13 | Steroid-dependent hemolytic anemia, mouth, and eye | Prednisone 60 mg/day and tacrolimus 1 mg a day alternating with 0.5 mg/day | Prednisone 0.5 mg 3 times a week | Anemia: severe | Anemia: mild | Restarted on bortezomib, 4 mo after the completion of the study to maintain the response |
Mouth 1 | Mouth 0 | |||||||
Eye 1 | Eye 0 | |||||||
6 | 08/02/13 | 09/03/13 | Steroid-refractory skin | Tacrolimus 1.5 mg twice daily | Tacrolimus 1.5 mg twice daily | Skin 3 | Skin 3 | Withdrawn from the study after one month due to relapse of the chronic myelomonocytic leukemia |
7 | 08/13/13 | 01/07/14 | Skin, eyes, and mouth | Tacrolimus 0.5 mg thrice daily, Sirolimus 1 mg daily, prednisone 30 mg daily | Tacrolimus 0.5 mg twice daily, prednisone 15 mg alternating with 5 mg daily | Skin 2 | Skin 1 | Responding but withdrawn early from the study due to neuropathy |
Eyes 2 | Eyes 1 | |||||||
Mouth 0 | Mouth 0 | |||||||
8 | 09/17/13 | 11/05/13 | Skin, mouth, and lung | Prednisone 30 mg daily, sirolimus 1 mg three times a week | Prednisone 15 mg daily alternating with 10 mg a day; tacrolimus 0.5 mg twice a day | Skin 3 | Skin 2 | Withdrawn early from the study due to symptomatic respiratory infections and hospital admissions |
Mouth 2 | Mouth 1 | |||||||
Lung 3 | Lung 3 | |||||||
9 | 09/20/13 | 03/14/14 | Skin, mouth, eyes, and liver | Cyclosporine 25 mg 3 times a week and prednisone 30 mg daily | None | Mouth 2 | Mouth 0 | Relapse of GVHD 4 mo after the last dose of the study drug |
Eye 2 | Eye 1 | |||||||
Skin 1 | Skin 0 | |||||||
10 | 12/6/13 | 1/24/14 | Steroid-intolerant and -dependent skin, mouth, and eyes | Prednisone 20 mg qod and cyclosporine 25 mg daily. | Prednisone 20mg qod and cyclosporine 25 mg daily. | Skin 3 | Skin 3 | Withdrawn early from the study due to low platelets |
Mouth 2 | Mouth 2 |
qod, every other day.