Treatment of chronic myelogenous leukemia with interleukin-2: a phase II study in 21 patients.


We designed a phase II study to assess the activity of recombinant interleukin-2 (rIL-2) in patients with chronic myelogenous leukemia (CML). Study population included 11 patients in the chronic phase of CML (6 in hematologic remission and 5 with active disease), 6 patients in the accelerated phase, and 4 in blastic phase of CML. Patients received three 5-day cycles administrated every other week. rIL-2 was given as intravenous bolus infusions of 8 x 10(6) IU/m2 three times a day during cycle 1 and twice a day during cycles 2 and 3. Response to rIL-2 was assessed on day 45. No hematologic response was achieved in the patients with evaluable disease. One patient in hematologic remission with rIL-2 achieved a major response (from 72% to 9% Ph+ metaphases), and two patients had some degree of reduction of Ph+ metaphases. Responses were short-lived (< 6 months), but two of these three patients achieved a new cytogenetic response with interferon given post-rIL-2. A significant immune activation was achieved with rIL-2 including a marked increase in CD3+/CD25+ cells, CD56+ cells, and in natural killer/lymphokine activated killer cell cytotoxic activity. These results confirm preclinical studies, which showed that IL-2 has antileukemic activity in CML. However, the responses observed were short lived and restricted to a subgroup of patients with low disease burden. This invites further studies testing its impact in situations of minimal disease or in combination with other cytokines.

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@article{Vey1999TreatmentOC, title={Treatment of chronic myelogenous leukemia with interleukin-2: a phase II study in 21 patients.}, author={Norbert Vey and Dackouo Blaise and Marina Lafage and Daniel Olive and Patrice Viens and Dr. Fr. Schmidt-La Baume and Jacques Camerlo and A . M . Stoppa and Ra{\'u}l Gab{\'u}s and Maud Brandely and Thierry Hercend and Dominique Maraninchi}, journal={Journal of immunotherapy}, year={1999}, volume={22 2}, pages={175-81} }