Results of Cancer and Leukemia Group B 10102 (Alliance), a Phase 1/2 Study

Results of Cancer and Leukemia Group B 10102 (Alliance), a Phase 1/2 Study

Background

Acute lymphoblastic leukemia (ALL) in adults is a serious illness. Treatment can be challenging due to resistance and side effects. Most cases of B- and T-lineage ALL have CD52, a target for treatment. Alemtuzumab is a monoclonal antibody that targets CD52, potentially improving treatment effectiveness while reducing side effects.

Methods

This study, CALGB 10102 (NCT00061945), involved adding alemtuzumab to standard chemotherapy after initial treatment for patients with CD52+ ALL. The study first tested three doses of alemtuzumab (10, 20, and 30 mg) to find a safe dose, which was determined to be 30 mg. The second phase confirmed the treatment’s feasibility.

Results

A total of 295 patients participated (115 in phase 1, 180 in phase 2), with 206 (69.8%) being CD52+. Among those treated, 43.7% completed the initial treatment modules, and 97.8% received alemtuzumab. Some patients experienced cytomegalovirus viremia during or after treatment. The average survival time was 26.3 months, with 3-year, 5-year, and 10-year survival rates at 44%, 36%, and 31%, respectively. There was no difference in survival between those who did and did not receive alemtuzumab after the fourth treatment course.

Conclusion

Alemtuzumab was safe for use in adults with ALL undergoing intensive chemotherapy, but it did not show any clear benefits in improving survival.

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