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Also known as Fludarabine Phosphate (Fludara), Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab, fludarabine phosphate
Fludarabine · 4 trials · 4 indications
Efficacy of the FMC therapy and Alemtuzumab Percentage and 95%-confidence-interval of response rates (CR, CRi, nPR, PR, SD and PD) will be provided.
| Arm | Type | Description |
|---|---|---|
| FCM-A followed by A-maintenance | EXPERIMENTAL | First treatment phase: Chemoimmunotherapy A-FMC maximum 4 cycles. Second treatment phase: Maintenance-treatment with 30mg Alemtuzumab s.c. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab | DRUG | I. First treatment phase: Chemoimmunotherapy A-FMC Alemtuzumab: Cycle 1+2: 10 mg s.c., days 1-3 Cycle 3+4: CR: 10 mg s.c., days 1-3 PR/SD: 30 mg s.c., days 1-3 Fludarabine: 20 mg/m2 i.v., days 1-3 Mitoxantrone: 6 mg/m2 i.v., day 1 Cyclophosphamide: 200 mg/m2 i.v., days 1-3 Repeat day 29, maximum 4 cycles. II. Second treatment phase: Maintenance-treatment with 30mg Alemtuzumab s.c. The maintenance therapy will start one month after the Final Staging and will be administered monthly during the first six months plus once in month 10 and 13. |
| Alemtuzumab | DRUG | maintenance with Alemtuzumab following a induction with combined immunochemotherapy consisting of Fludarabine, cyclophosphamide, mitoxantrone and alemtuzumab |
| Fludarabine Phosphate (Fludara) | DRUG | Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD) |
| Rituximab | DRUG | Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD) |
Inclusion Criteria: * Untreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL * Age ≥ 18 years * WHO performance status of 0-2 * Life expectancy \> 6 months * CIRS score \>= 6 * Left ventricular ejection fra...
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