At a glance
ClinicalIndex Comparison Record- ✓Confirmed B-cell chronic lymphocytic leukemia diagnosis per NCI Working Group criteria
- ✓Relapsed or refractory disease after 1 prior regimen; patients refractory to fludarabine or alemtuzumab are ineligible, but those who responded and relapsed >12 months later may be eligible
- ✓Evidence of disease progression: marrow failure (Hgb <11 g/dL, platelets <100×10⁹/L, or ANC <1.0×10⁹/L), splenomegaly >2 cm below costal margin, progressive lymphadenopathy, or lymphocytosis doubling time <6 months
- ✓WHO performance status 0 or 1
- ✕Prior treatment with >1 regimen for B-CLL
- ✕Prior FluCAM (fludarabine plus alemtuzumab) therapy
- ✕Positive Coombs test with active hemolysis
- ✕Cytopenias unless from bone marrow involvement: ANC <1.5×10⁹/L or platelets <75×10⁹/L
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia
In Brief
A Phase 3 clinical trial evaluating FluCAM [Fludara + Campath] and fludarabine phosphate for B-Cell Chronic Lymphocytic Leukemia. Completed, enrolled 335 participants across 48 sites in 15 countries.
Detailed Summary
This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.
Study Details
Timeline
Interventions
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 (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.