Characteristics of the patients
| Pt. . | Sex (age, y) . | Diagnosis . | Disease status at SCT . | Conditioning . | Infused CD34+/kg at SCT . | Infused CD3+/kg at SCT . | Infused T cells/kg (no. of infusions) . | Time to T-cell infusion (day after SCT) . | Time to off study or received other T cells/stem cells (day after T-cell infusion) . | Acute GVHD (grade) . | Virus reactivation . | Immune responses detected from infused CD3+CD19+ T cells . | Current status (day after SCT*) . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | M (49) | T-cell ALL | Active | Cy-Campath-TBI | 1.31 × 107 | 2.34 × 103 | 1 × 104 (1) | 31 | 315 | None | EBV | N/A | Relapse (D+150), Alive (D+674 after 2nd SCT) |
| 2 | M (4) | ALL (CNS) | CR2 | AraC-Cy-Campath-TBI | 1.56 × 107 | 7.31 × 103 | 1 × 104 (1) | 61 | 81 | None | CMV | N/A | Death from progressive disease (D+142) |
| 3 | M (2) | JMML | Active | AraC-Cy-Campath-TBI | 2.82 × 107 | 2.5 × 104 | 1 × 105 (1) | 32 | 115 | None | EBV, AdV | N/A | Death from progressive disease (D+147) |
| 4 | M (10) | ALL | CR3 | craniospinal XRT+ AraC-Cy-Campath-TBI | 1.58 × 107 | 1.9 × 103 | 1 × 105 (1) | 38 | 31 | None | N/A | N/A | Withdrawal from study (D+166) |
| 5 | F (10) | MDS | CR3 | Flu-Mel-Campath | 2.22 × 107 | 5.21 × 103 | 1 × 105 (1) | 82 | 782 | None | CMV, EBV | EBV | Death from progressive disease (D+864) |
| 6 | M (50) | T-cell ALL | CR3 | Flu-Mel-Campath | 1.4 × 107 | 2.42 × 103 | 5 × 105 (1) | 36 | N/A | Skin I, gut I | VZV, EBV | VZV, EBV | Relapse (D+408), alive (D+674) |
| 7 | F (4) | EBV-LPD | CR1 | Flu-Campath-TBI | 1.31 × 107 | 2.05 × 103 | 5 × 105 (2) | 42 (#1) | 201 | None | EBV, CMV, AdV, HHV6 | EBV, AdV, HHV6 | CD34 top off (D+243 for mixed chimera), alive in CR (D+551) |
| 116 (#2) | |||||||||||||
| 8 | M (15) | MDS | CR3 | Flu-Campath-TBI | 1.05 × 107 | 1.47 × 103 | 1 × 106 (1) | 42 | 59 | Skin II | CMV, EBV, BKV | CMV, EBV | Received another T-cells on D+101, alive in CR (D+400) |
| 9 | M (8) | HLH (CNS) | Extensive prior therapy | Flu-Mel-Campath | 1.62 × 107 | 5.19 × 103 | 1 × 106 (1) | 47 | 248 | Skin II, liver (stage 2 ALT) | CMV, EBV, BKV | CMV, EBV, BKV | Death from zygomycetes infection (D+295) |
| 10 | M (9) | AML | CR2 | Cranial XRT + Bu-Cy-Campath | 1.13 × 107 | 1.26 × 103 | 5 × 106 (1) | 40 | 28 | None | CMV, BKV | CMV | Received another T-cells on D+68, alive (D+278) |
| 11 | F (17) | ALL | CR1 | AraC- Cy-Campath-TBI | 1.01 × 107 | 3.34 × 103 | 5 × 106 (1) | 73 | N/A | None | HHV6, EBV, VZV | HHV6, EBV, VZV | Alive in CR (D+306) |
| 12 | M (19) | AML | CR2 | Flu-Campath-TBI | 4.07 × 106 | 8.41 × 102 | 5 × 106 (1) | 46 | 38 | CNS GVHD? | CMV, BKV | CMV | Death from encephalopathy due to extensive prior treatment including 3 previous transplants (D+84) |
| Pt. . | Sex (age, y) . | Diagnosis . | Disease status at SCT . | Conditioning . | Infused CD34+/kg at SCT . | Infused CD3+/kg at SCT . | Infused T cells/kg (no. of infusions) . | Time to T-cell infusion (day after SCT) . | Time to off study or received other T cells/stem cells (day after T-cell infusion) . | Acute GVHD (grade) . | Virus reactivation . | Immune responses detected from infused CD3+CD19+ T cells . | Current status (day after SCT*) . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | M (49) | T-cell ALL | Active | Cy-Campath-TBI | 1.31 × 107 | 2.34 × 103 | 1 × 104 (1) | 31 | 315 | None | EBV | N/A | Relapse (D+150), Alive (D+674 after 2nd SCT) |
| 2 | M (4) | ALL (CNS) | CR2 | AraC-Cy-Campath-TBI | 1.56 × 107 | 7.31 × 103 | 1 × 104 (1) | 61 | 81 | None | CMV | N/A | Death from progressive disease (D+142) |
| 3 | M (2) | JMML | Active | AraC-Cy-Campath-TBI | 2.82 × 107 | 2.5 × 104 | 1 × 105 (1) | 32 | 115 | None | EBV, AdV | N/A | Death from progressive disease (D+147) |
| 4 | M (10) | ALL | CR3 | craniospinal XRT+ AraC-Cy-Campath-TBI | 1.58 × 107 | 1.9 × 103 | 1 × 105 (1) | 38 | 31 | None | N/A | N/A | Withdrawal from study (D+166) |
| 5 | F (10) | MDS | CR3 | Flu-Mel-Campath | 2.22 × 107 | 5.21 × 103 | 1 × 105 (1) | 82 | 782 | None | CMV, EBV | EBV | Death from progressive disease (D+864) |
| 6 | M (50) | T-cell ALL | CR3 | Flu-Mel-Campath | 1.4 × 107 | 2.42 × 103 | 5 × 105 (1) | 36 | N/A | Skin I, gut I | VZV, EBV | VZV, EBV | Relapse (D+408), alive (D+674) |
| 7 | F (4) | EBV-LPD | CR1 | Flu-Campath-TBI | 1.31 × 107 | 2.05 × 103 | 5 × 105 (2) | 42 (#1) | 201 | None | EBV, CMV, AdV, HHV6 | EBV, AdV, HHV6 | CD34 top off (D+243 for mixed chimera), alive in CR (D+551) |
| 116 (#2) | |||||||||||||
| 8 | M (15) | MDS | CR3 | Flu-Campath-TBI | 1.05 × 107 | 1.47 × 103 | 1 × 106 (1) | 42 | 59 | Skin II | CMV, EBV, BKV | CMV, EBV | Received another T-cells on D+101, alive in CR (D+400) |
| 9 | M (8) | HLH (CNS) | Extensive prior therapy | Flu-Mel-Campath | 1.62 × 107 | 5.19 × 103 | 1 × 106 (1) | 47 | 248 | Skin II, liver (stage 2 ALT) | CMV, EBV, BKV | CMV, EBV, BKV | Death from zygomycetes infection (D+295) |
| 10 | M (9) | AML | CR2 | Cranial XRT + Bu-Cy-Campath | 1.13 × 107 | 1.26 × 103 | 5 × 106 (1) | 40 | 28 | None | CMV, BKV | CMV | Received another T-cells on D+68, alive (D+278) |
| 11 | F (17) | ALL | CR1 | AraC- Cy-Campath-TBI | 1.01 × 107 | 3.34 × 103 | 5 × 106 (1) | 73 | N/A | None | HHV6, EBV, VZV | HHV6, EBV, VZV | Alive in CR (D+306) |
| 12 | M (19) | AML | CR2 | Flu-Campath-TBI | 4.07 × 106 | 8.41 × 102 | 5 × 106 (1) | 46 | 38 | CNS GVHD? | CMV, BKV | CMV | Death from encephalopathy due to extensive prior treatment including 3 previous transplants (D+84) |
Conditioning regimen: Patient 1: Cy: 120 mg/kg, Campath: 30 mg, TBI 1200 cGy. Patients 2, 3, 4, and 11: Ara-C: 3 g/m2 per dose for 6 doses; Cy: 45 mg/kg; Campath 5 mg to 10 mg per dose for 3 doses; TBI: 1400 cGy over 4 days. Patients 5 and 6: Flu 150 mg/m2, Campath: 30 mg, Mel: 140 mg/m2. Patients 7 and 8: Flu 120 mg/m2, Campath: 40 mg, TBI: 600 cGy. Patient 9: Flu 150 mg/m2, Campath: 0.86 mg/kg, Mel: 140 mg/m2. Patient 10: Bu: 12.8 mg/kg, Cy: 200 mg/kg, Campath: 40 mg. Patient 12: Flu: 150 mg/m2, Campath: 40 mg, TBI: 600 cGy.
ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; AraC, cytosine arabinoside; AdV, adenovirus; Bu, busulfan; CR, complete remission; Cy, cyclophosphamide; D, day; F, female; Flu, fludarabine; HLH, hemophagocytic lymphohistiocytosis; JMML, juvenile myelomonocytic leukemia; LPD, lymphoproliferative disorder; M, male; MDS, myelodysplastic syndrome; Mel, melphalan; N/A, not applicable; Pt., patient; TBI, total body irradiation; XRT, irradiation.
Follow-up as of December 31, 2014.