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Alert Number 11

Combination of Rituxan plus Campath in Relapsed CLL Patients

Date: April 13, 2004

A couple of you wrote and asked about the idea of combining Rituxan and Campath in relapsed CLL patients. The abstract below from M. D. Anderson speaks to this particular combination. Out of 48 patients (32 of them were CLL patients), CRs (Complete Response) were a disappointing 8%, and partial responses at 44%. The remission duration was also not much to write home about. But as you read more of these clinical trial statistics, please bear in mind that statistics do not necessarily reflect any individual patient's response, just the overall probabilities. You might get lucky and do a whole lot better, or not. I also think a great deal depends on the rest of the details, such as your overall health, the level of prior chemotherapy regimes, your particular cytogenetics (FISH), other complicating features and prognostics.

All in all, I confess I expected better from this combination of both monoclonals. The results are a disappointment for many of us who considered this a way of "taking it up a notch" without necessarily taking on standard chemotherapy. Oh well, live and learn. I am in the process of writing up another interesting clinical trial where I was surprised too, but in a positive sense.

Be well,



Blood. 2003 May 1;101(9):3413-5.

Experience with alemtuzumab plus rituximab in patients with relapsed and refractory lymphoid malignancies.

Faderl S, Thomas DA, O'Brien S, Garcia-Manero G, Kantarjian HM, Giles FJ, Koller C, Ferrajoli A, Verstovsek S, Pro B, Andreeff M, Beran M, Cortes J, Wierda W, Tran N, Keating MJ.

Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

We explored the safety and efficacy of rituximab plus alemtuzumab in patients with relapsed or refractory lymphoid malignancies. Forty-eight patients were treated and were assessable for response (32 with chronic lymphocytic leukemia [CLL], 9 with CLL/prolymphocytic leukemia [PLL], 1 with PLL, 4 with mantle cell leukemia/lymphoma, 2 with Richter transformation). The overall response rate was 52% (complete remission, 8%; nodular partial response, 4%; partial response, 40%). With a median follow-up of 6.5 months (range, 1-20 months), the median time to progression was 6 months (range, 1-20 months); median survival, 11 months (11+ months for responders vs 6 months for nonresponders). Most toxicities were grade 2 or lower and infusion-related. Infections occurred in 52% of the patients. Cytomegalovirus (CMV) antigenemia assays were positive in 27% of the patients, but only 15% were symptomatic and required therapy. The combination of rituximab and alemtuzumab is feasible, has an acceptable safety profile, and has clinical activity with a short course in a group of patients with poor prognoses.

PMID: 12522009

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