open access

Vol 52, No 4 (2021)
Review article
Submitted: 2021-06-27
Accepted: 2021-06-27
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Tolerance and efficacy of total body irradiation and cladribine prior to allogeneic hematopoietic cells transplantation in patients with acute myeloid leukemia and myelodysplastic syndromes — synopsis of clinical study

Małgorzata Sobczyk-Kruszelnicka1, Sebastian Giebel1
DOI: 10.5603/AHP.2021.0047
·
Acta Haematol Pol 2021;52(4):242-244.
Affiliations
  1. Department of Bone Marrow Transplantation and Oncohematology, Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice Branch, Gliwice, Poland

open access

Vol 52, No 4 (2021)
REVIEW ARTICLE
Submitted: 2021-06-27
Accepted: 2021-06-27

Abstract

Introduction: Allogeneic hematopoietic cell transplantation (allo-HCT) is a standard of care for patients with acute myeloid leukemia (AML) and patients with intermediate and high-risk myelodysplastic syndrome (MDS). Despite many years of experience. there is still no standard for conditioning regimen. The aim of this study is to analyse the efficacy and safety of a conditioning treatment with cladribine in combination with total body irradiation (TBI).

Material and methods: A group of 40 adult patients referred for allo-HCT due to AML and MDS are to be enrolled in the study. The inclusion criteria are: informed consent, chemo-sensitivity for cladribine treatment regimens (when used in induction therapy), age 18–60, and performance status 0–2 according to World Health Organization. The conditioning regimen consists of cladribine and TBI at a total dose of 12 Gy in three fractions given over three consecutive days. The goal of the study is to assess the tolerability and efficacy of the regimen.

Results: Our results may stimulate further investigation in this field i.e. phase III trials to compare this regimen to others.

Conslusion: A myeloablative conditioning regimen consisting of total body irradiation in combination with cladribine may contribute to improved outcomes after allo-HCT for AML and MDS patients.

Abstract

Introduction: Allogeneic hematopoietic cell transplantation (allo-HCT) is a standard of care for patients with acute myeloid leukemia (AML) and patients with intermediate and high-risk myelodysplastic syndrome (MDS). Despite many years of experience. there is still no standard for conditioning regimen. The aim of this study is to analyse the efficacy and safety of a conditioning treatment with cladribine in combination with total body irradiation (TBI).

Material and methods: A group of 40 adult patients referred for allo-HCT due to AML and MDS are to be enrolled in the study. The inclusion criteria are: informed consent, chemo-sensitivity for cladribine treatment regimens (when used in induction therapy), age 18–60, and performance status 0–2 according to World Health Organization. The conditioning regimen consists of cladribine and TBI at a total dose of 12 Gy in three fractions given over three consecutive days. The goal of the study is to assess the tolerability and efficacy of the regimen.

Results: Our results may stimulate further investigation in this field i.e. phase III trials to compare this regimen to others.

Conslusion: A myeloablative conditioning regimen consisting of total body irradiation in combination with cladribine may contribute to improved outcomes after allo-HCT for AML and MDS patients.

Get Citation

Keywords

allo-HCT, myeloablative regimen, transplantation, cladribine, total body irradiation, TBI

About this article
Title

Tolerance and efficacy of total body irradiation and cladribine prior to allogeneic hematopoietic cells transplantation in patients with acute myeloid leukemia and myelodysplastic syndromes — synopsis of clinical study

Journal

Acta Haematologica Polonica

Issue

Vol 52, No 4 (2021)

Article type

Review article

Pages

242-244

DOI

10.5603/AHP.2021.0047

Bibliographic record

Acta Haematol Pol 2021;52(4):242-244.

Keywords

allo-HCT
myeloablative regimen
transplantation
cladribine
total body irradiation
TBI

Authors

Małgorzata Sobczyk-Kruszelnicka
Sebastian Giebel

References (9)
  1. Stelljes M, Bornhauser M, Kroger M, et al. Cooperative German Transplant Study Group. Conditioning with 8-Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia. Blood. 2005; 106(9): 3314–3321.
  2. Bornhäuser M, Kienast J, Trenschel R, et al. Reduced-intensity conditioning versus standard conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: a prospective, open-label randomised phase 3 trial. Lancet Oncol. 2012; 13(10): 1035–1044.
  3. Holowiecki J, Grosicki S, Robak T, et al. Polish Adult Leukemia Group (PALG). Addition of cladribine to daunorubicin and cytarabine increases complete remission rate after a single course of induction treatment in acute myeloid leukemia. Multicenter, phase III study. Leukemia. 2004; 18(5): 989–997.
  4. Hołowiecki J, Grosicki S, Kyrcz-Krzemien S, et al. Daunorubicin, cytarabine and fludarabine (DAF) for remission induction in relapsed or refractory acute myeloid leukemia. Evaluation of safety, tolerance and early outcome--Polish Adult Leukemia Group (PALG) pilot study. Ann Hematol. 2008; 87(5): 361–367.
  5. National Comprehensive Cancer Network. Bone Cancer (Version 3.2021). http://www.nccn.org/professionals/physician_gls/pdf/bone.pdf (March 02, 2021).
  6. Holowiecki J, Grosicki S, Giebel S, et al. Cladribine, but not fludarabine, added to daunorubicin and cytarabine during induction prolongs survival of patients with acute myeloid leukemia: a multicenter, randomized phase III study. J Clin Oncol. 2012; 30(20): 2441–2448.
  7. Markova M, Barker JN, Miller JS, et al. Fludarabine vs cladribine plus busulfan and low-dose TBI as reduced intensity conditioning for allogeneic hematopoietic stem cell transplantation: a prospective randomized trial. Bone Marrow Transplant. 2007; 39(4): 193–199.
  8. Saito T, Kanda Y, Nakai K, et al. Immune reconstitution following reduced-intensity transplantation with cladribine, busulfan, and antithymocyte globulin: serial comparison with conventional myeloablative transplantation. Bone Marrow Transplant. 2003; 32(6): 601–608.
  9. Giralt S, Thall PF, Khouri I, et al. Melphalan and purine analog-containing preparative regimens: reduced-intensity conditioning for patients with hematologic malignancies undergoing allogeneic progenitor cell transplantation. Blood. 2001; 97(3): 631–637.

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