Early induction intensification with cladribine, cytarabine, and mitoxantrone (CLAM) in AML patients treated with the DAC induction regimen: a prospective, non-randomized, phase II study of the Polish Adult Leukemia Group (PALG)

Abstract

We present the results of a prospective, non-randomized phase 2 trial in which 253 AML patients (pts) under 60 years old received DAC (Daunorubicin + AraC + Cladribine) as first induction followed by CLAM (Cladribine + AraC + Mitoxantrone) as early second induction on day 16 based on bone marrow (BM) blasts on day 14 (D14). The CR/CRi rate after a single course of DAC was 83% for pts with D14 BM blasts less than 10%. Forty-six pts had >10% BM blasts on D14, of whom 35 received CLAM with rates of CR/CRi 60% and early death (ED) 23%. The remaining 11 pts were not fit to receive CLAM, with rates of CR/CRi 28%, PR 18%, and ED 18%. Median OS was 7.2 versus 7.5 months, respectively. The overall CR/CRi rate was 77% after the first induction, with final CR/CRi rate 80% after DAC reinduction for pts who achieved PR with initial DAC course. CLAM used as early second induction might improve CR/CRi rates for younger AML pts with poor early response to DAC induction, but may be associated with higher mortality.

Keywords:

• CLAM
• early second induction
• AML

Acknowledgments

The authors would like to acknowledge Mr Edward Lowczowski from the Medical University of Lodz, Poland, who has read the text and has made language corrections.

Statement of prior presentation

The preliminary results were presented in abstract form at the 58th annual meeting of the American Society of Hematology, San Diego, CA, 3 December 2016.

Disclosure statement

The authors declare no competing financial interests.

Authorship

The first and last version of the manuscript was written by AP, AW, TR and SG. All authors collected patient data and cooperated on the final shape of the manuscript.

Additional information

Funding

The study was supported by grant funding from the Medical University of Lodz, Poland: No. 503/1-093-01/503-11-004.