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Sequential regimen of clofarabine, cytosine arabinoside and reduced-intensity conditioned transplantation for primary refractory acute myeloid leukemia.
- Source :
-
Haematologica [Haematologica] 2017 Jan; Vol. 102 (1), pp. 184-191. Date of Electronic Publication: 2016 Aug 25. - Publication Year :
- 2017
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Abstract
- The prognosis of patients with acute myeloid leukemia in whom primary treatment fails remains very poor. In order to improve such patients' outcome, we conducted a phase 2, prospective, multicenter trial to test the feasibility of a new sequential regimen, combining a short course of intensive chemotherapy and a reduced intensity-conditioning regimen, before allogeneic stem-cell transplantation. Twenty-four patients (median age, 47 years) with acute myeloid leukemia in primary treatment failure were included. Cytogenetic risk was poor in 15 patients (62%) and intermediate in nine (38%). The sequential regimen consisted of clofarabine (30 mg/m <superscript>2</superscript> /day) and cytosine arabinoside (1 g/m <superscript>2</superscript> /day) for 5 days, followed, after a 3-day rest, by reduced-intensity conditioning and allogeneic stem-cell transplantation combining cyclophosphamide (60 mg/kg), intravenous busulfan (3.2 mg/kg/day) for 2 days and anti-thymocyte globulin (2.5 mg/kg/day) for 2 days. Patients in complete remission at day +120 received prophylactic donor lymphocyte infusion. Eighteen patients (75%) achieved complete remission. With a median follow-up of 24.6 months, the Kaplan-Meier estimate of overall survival was 54% (95% CI: 33-71) at 1 year and 38% (95% CI: 18-46) at 2 years. The Kaplan-Meier estimate of leukemia-free survival was 46% (95% CI: 26-64) at 1 year and 29% (95% CI: 13-48) at 2 years. The cumulative incidence of non-relapse mortality was 8% (95% CI: 1-24) at 1 year and 12% (95% CI: 3-19) at 2 years. Results from this phase 2 prospective multicenter trial endorsed the safety and efficacy of a clofarabine-based sequential reduced-toxicity conditioning regimen, which warrants further investigation. This study was registered at www.clinicaltrials.gov, identifier number: NCT01188174.<br /> (Copyright© Ferrata Storti Foundation.)
- Subjects :
- Adenine Nucleotides administration & dosage
Adult
Antineoplastic Combined Chemotherapy Protocols adverse effects
Arabinonucleosides administration & dosage
Clofarabine
Cytarabine administration & dosage
Drug Resistance, Neoplasm
Female
Graft Survival
Graft vs Host Disease diagnosis
Graft vs Host Disease etiology
Graft vs Host Disease prevention & control
Humans
Leukemia, Myeloid, Acute diagnosis
Leukemia, Myeloid, Acute mortality
Male
Middle Aged
Retreatment
Survival Analysis
Tissue Donors
Transplantation Chimera
Transplantation, Homologous
Treatment Outcome
Young Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Hematopoietic Stem Cell Transplantation adverse effects
Hematopoietic Stem Cell Transplantation methods
Leukemia, Myeloid, Acute therapy
Transplantation Conditioning methods
Subjects
Details
- Language :
- English
- ISSN :
- 1592-8721
- Volume :
- 102
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Haematologica
- Publication Type :
- Academic Journal
- Accession number :
- 27561720
- Full Text :
- https://doi.org/10.3324/haematol.2016.150326