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Also known as Fludarabine Phosphate (Fludara), fludarabine phosphate, Mabcampath, Endoxan, Novantron, BAY86-4864
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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Fludarabine is used to treat several blood cancers, including lymphoma, low-grade lymphoma, non-Hodgkin lymphoma, and T-cell prolymphocytic leukemia. It is a small molecule oncology drug studied both as a single agent and in combination regimens for these hematologic malignancies.
Fludarabine is developed by Sanofi, which trades under the ticker SNY. The company is associated with the fludarabine phosphate formulation, including the oral Fludara product studied in lymphoma trials.
Fludarabine has been studied in Phase 2 clinical development. Its registered trials are all Phase 2 studies, and the drug is investigational in the settings covered by these trials rather than described as approved for them.
Fludarabine appears in completed Phase 2 trials including NCT01186640 in T-prolymphocytic leukemia, NCT00688883 in indolent lymphoma, NCT00311129 in low-grade non-Hodgkin lymphoma, and NCT00185445 in follicular non-Hodgkin lymphoma. These studies were conducted in Germany, Japan, and Italy.
Yes. Fludarabine phosphate is the same agent as fludarabine and is also marketed under the name Fludara. The combination regimen fludarabine, mitoxantrone, cyclophosphamide, and alemtuzumab is another name associated with fludarabine in the literature.
Fludarabine trials have enrolled a total of 62 patients in the reported study population. The trials were uncontrolled and non-randomized, with enrollment across lymphoma and T-cell prolymphocytic leukemia indications in Germany, Japan, and Italy.