Fludarabine, Cyclophosphamide, Ofatumumab May Be Safe, Effective for CLL

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Preliminary results showed that fludarabine plus cyclophosphamide is well tolerated in chronic lymphocytic leukemia.
Preliminary results showed that fludarabine plus cyclophosphamide is well tolerated in chronic lymphocytic leukemia.

Preliminary results showed that fludarabine plus cyclophosphamide and a double dose of ofatumumab (FC-O2) is associated with a high rate of cytometric minimal residual disease (MRD)-negative complete response and is well tolerated in young and fit patients with previously untreated chronic lymphocytic leukemia (CLL).1

Fludarabine plus cyclophosphamide and rituximab is considered the optimal first-line treatment for fit patients with CLL, but the same chemotherapy with ofatumumab has also been associated with a high complete response rate. Therefore, researchers sought to evaluate whether FC-O2 could improve the complete response rate in young and fit patients with CLL.

For the study, researchers enrolled 61 fit patients with CLL to receive fludarabine 25 mg/m2 IV on days 1-3 plus cyclophosphamide 250 mg/m2 IV on days 1-3. Ofatumumab was administered at a dose of 300 mg IV on day 14 and 1000 mg on day 21 in cycle 1, and 1000 mg on days 1 and 15 in cycles 2-6 and day 28 in cycle 6.

Results showed that at a median follow-up of 7 months, the overall response rate in 29 evaluable patients was 90% with a complete response rate of 69%.

RELATED: Adding Ibrutinib to R-Bendamustine Improves Outcomes in R/R CLL/SLL

Researchers observed no evidence of MRD by flow cytometry in either peripheral blood or bone marrow in 75% of patients who achieved complete responses.

In regard to safety, 7% of patients experienced grade 3-4 granulocytopenia, 7% developed a severe infection, and 8% experienced a severe infusion-related reaction during ofatumumab administration. A total of 8 patients discontinued therapy due to toxicity.

Reference

  1. Mauro FR, Zaja F, Molica S, et al. Fludarabine, cyclophosphamide, ofatumumab (FC-O2) as front-line treatment for young and fit patients with chronic lymphocytic leukemia (CLL): preliminary results of the prospective phase 2 LLC0911 Gimema study [abstract]. Blood. 2015;126(23):2946.

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