Table 5. Comparison of F-araA PK with previous reports.
| Sl. no | Diagnosis | N | Conditioning regimen | F-araA dose | Type of donor | AUC (μm × h) median (range) | CL (L/h/m2) median (range) | Ref |
|---|---|---|---|---|---|---|---|---|
| 1 | AML-05; CML-01; MDS-04; MF-05; CMML-01 | 16 | F-araA: days −6 to −2; targeted daily IV Bu days −5 to −2;rATG on days −3 to −1 | 50 mg/m2/day | MRD-11 MUD-05 | 24.8 (16.3–39.9) | — | 21 |
| 2 | ALL-06; AML-26; NHL-17; MDS-14; HL-08; CML-01; Other-15 | 87 | F-araA: days −6 to −2; Cy day −6 | 40 mg/m2/day (N=78) or 30-35 mg/m2/day (N=9) | MRD-22 MUD-65 | 40 mg/m2: 17.19 (7.02–40.35) 30-35 mg/m2 : 19.29 (15.08–24.56) | 40 mg/m2: 16.0 (6.2–36.6)L/h; 30-35 mg/m2 : 11.5 (6.9–15.2) L/h | 22 |
| 3 | AML-05; MM-03; MDS-03; Others-05 | 16 | F-araA: day −6 to −3; Bu: day −5 to −2 | 30 mg/m2/day | - | 21.03 (10.17–38.56) | 5.04 (2.7–10.2) | 33 |
| 4 | CML-04; MDS-38 | 42 | F-araA : 4 days; Oral Bu : 4 days | 30 mg/m2/day | MRD-16 MUD-26 | Mean: 19.1 (s.d. 7.0) Range: 8.0–45.2 | Mean: 6.3 (s.d. 2.4) Range : 2.2–13.3 | 34 |
| 5 | NHL-34; CLL-22; AML-15; MDS-10; MM-09; Others-12 | 102 | Flu: days −4 to day −2 2–4.5 Gy TBI | 30 mg/m2/day | MRD-24 MUD-78 | Mean±s.d. (Range) 19.6±4.80 (9.96–36.4) | — | 35 |
| 6 | NHL-05; HL-03; AML/MDS-03 | 11 | Flu: days −6 to −2; CY days −6 and −5; TBI day −1 | 30 mg/m2/day | Haplo-11 | 16.4 (10.4–21.5) | — | 36 |
| 7 | MDS-18; AML-13; CML-05; CMML-02; MF-03 | 41 | Protocol 1519 (N=27) Flu: days −9 to −6; targeted oral Bu days −5 to −2 Protocol 2041 (N=14) Flu: days −6 to −2, targeted daily IV Bu on days −5 to −2, and rATG IV on day −3, to −1 | 30 mg/m2/day 50 mg/m2/day | — | — | Protocol 1519: 9.1 (8–45.2); Protocol 2041: 7.07 (4.40–10.76) | 37 |
| 8 | AA-40; FA-13 | 53 | Flu: day −6 to day −2 Cy: Day −3 and day −2 | 30 mg/m2/day | MSD-45 AD-08 | AA-12.34 (3.63-52.47) FA-29.76 (20.37-52.89 | AA-6.47(1.24–22.43) FA-2.22 (1.41–3.08) | Present study |
Abbreviations: AA=Aplastic Anemia; AUC=area under the curve; FA=Fanconi Anemia; F-araA=fludarabine; PK=pharmacokinetics.
Dose and the PK parameters of AA was comparable to all the studies although the underlying disease and the combination of conditioning regimen are variable among the different studies.