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FluCAM · 1 trial · 1 indication
Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.
| Arm | Type | Description |
|---|---|---|
| Combination Arm (FluCAM) | EXPERIMENTAL | - |
| Fludarabine Alone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FluCAM [Fludara + Campath] | BIOLOGICAL | Phase A: Escalating Doses of alemtuzumab (Campath) Alone Day 1: alemtuzumab 3 mg intravenously (IV) over 2 hours. Day 2: alemtuzumab 10 mg IV over 2 hours if 3 mg was tolerated, else repeat 3 mg daily until tolerated. Day 3: alemtuzumab 30 mg IV over 2 hours if 10 mg was tolerated, else repeat 10 mg daily until tolerated. Participants were allowed 3-14 days to escalate to 30 mg. Once 30 mg was tolerated, the participant had to begin Phase B within 7 days. Phase B: FluCAM Cycle 1: Days 1,2,3 fludarabine phosphate administered at 30 mg/m\^2 over 30 minutes IV, followed within 1 hour by alemtuzumab 30 mg IV over 2 hours. A similar schedule is set for Cycles 2 through 6; duration of alemtuzumab infusions vary from 2-6 hours. Each 28-day period is 1 cycle. Fludarabine phosphate dosage is based on participants' body surface area at the beginning of each cycle. FluCAM administered up to a maximum of 6 cycles, based upon participants' response to therapy and toxicity. |
| fludarabine phosphate | BIOLOGICAL | Fludarabine phosphate (Fludara) is administered at a dose of 25 mg/m\^2 IV over 15 to 30 minutes daily for 5 consecutive days (days 1 through 5) every 28 days (per package instructions). Each 28-day period is 1 cycle. The dose of fludarabine phosphate will be based on the participant's body surface area as calculated at the beginning of each cycle. Participants treated with fludarabine phosphate up to a maximum of 6 cycles, based upon their response to therapy and toxicity. |
Inclusion Criteria: * A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National Cancer Institute Working Group (NCI WG) criteria. * Relapsed or refractory disease after 1 prior regimen except patients who were refractory to (i.e., progressed on) fludarabine or alemtuzuma...
FluCAM is a combination treatment for B-Cell Chronic Lymphocytic Leukemia that pairs fludarabine (Fludara) with alemtuzumab (Campath). It is a monoclonal antibody based regimen developed by Sanofi, which trades under the ticker SNY. The combination was studied in a Phase 3 trial comparing it against fludarabine alone.
FluCAM is used for B-Cell Chronic Lymphocytic Leukemia, a cancer of the blood and bone marrow. It combines fludarabine with alemtuzumab and was evaluated in a Phase 3 active controlled trial of 335 patients. The study compared FluCAM against fludarabine alone in adults with B-CLL.
FluCAM is developed by Sanofi, which trades under the ticker SNY. The regimen combines fludarabine, marketed as Fludara, with alemtuzumab, marketed as Campath. Sanofi sponsored the Phase 3 trial evaluating the combination in B-Cell Chronic Lymphocytic Leukemia.
FluCAM is in Phase 3 development for B-Cell Chronic Lymphocytic Leukemia. One Phase 3 trial has been completed, and no trials are currently active. The completed study enrolled 335 patients and was randomized and active controlled, comparing FluCAM against fludarabine alone.
FluCAM has been studied in one completed Phase 3 trial, NCT00086580, titled Fludarabine Plus Alemtuzumab versus Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia Patients. The trial enrolled 335 adults across the United States, Canada, and multiple European countries, including Austria, France, Germany, Italy, Poland, and others.