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Clinical Trial
. 2019 Jul;54(7):1049-1057.
doi: 10.1038/s41409-018-0382-3. Epub 2018 Nov 16.

Low-dose anti-thymocyte globulin plus low-dose posttransplant cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell transplantation combined with unrelated cord blood for patients with hematologic malignancies: a prospective, phase II study

Jun Yang  1 , Jieling Jiang  1 , Yu Cai  1 , Su Li  1 , Liping Wan  1 , Jun Zhu  1 , Huixia Liu  1 , Shan Shao  1 , Haitao Bai  1 , Chun Wang  1 , Xianmin Song  2
Affiliations
Clinical Trial

Low-dose anti-thymocyte globulin plus low-dose posttransplant cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell transplantation combined with unrelated cord blood for patients with hematologic malignancies: a prospective, phase II study

Jun Yang et al. Bone Marrow Transplant. 2019 Jul.

Abstract

Nowadays, the most wildly used regimens for graft-versus-host disease (GvHD) prophylaxis in haplo-hematopoietic stem cell transplantation (Haplo-HSCT) are based on in vivo T-cell depletion (TCD) with anti-thymocyte globulin (ATG) or posttransplant cyclophosphamide (PTCy). To improve the efficiency of GvHD prophylaxis in haploidentical peripheral blood stem cell transplantation combined with unrelated cord blood (Haplo-PBSCT-Cord), a novel regimen, which is composed of low dose of ATG (5 mg/kg) and low-dose PTCy (50 mg/kg) for GvHD prophylaxis, was evaluated in a prospective phase II clinical trial (Clinicaltrials.org NCT03395860). Thirty-two patients diagnosed with hematological malignancies were enrolled in this trial. All patients received myeloablative conditioning regimens except for three patients. The cumulative incidences (CIs) of grades II-IV and III-IV acute GvHD were 19.4% (95% CI, 5.5-33.3%) and 6.9% (95% CI, 0-16.3%) by day 100, respectively. The 1-year probability of relapse, disease free survival (DFS) and overall survival (OS) was 25.1% (95% CI, 7.3-42.9%), 59% (95% CI, 33.3-84.7%) and 78.4% (95% CI, 63-93.8%), respectively. The CIs of CMV and EBV reactivation by day 180 were 37.5% (95% CI, 19.8-55.2%) and 40.6% (95% CI, 22.6-58.6%), respectively. The results suggested that low-dose ATG with low-dose PTCy as GvHD prophylaxis in Haplo-PBSCT-Cord had promising activity.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
The schema of myeloablative conditioning (MAC) regimens for myeloid malignancies and acute lymphoblastic leukemia
Fig. 2
Fig. 2
Immune reconstitution after transplantation (data were shown as median cell counts/μl)
Fig. 3
Fig. 3
The cumulative incidences (CIs) of graft-versus-host disease (GvHD). a The CIs of grades II-IV aGvHD. b The CIs of grades III-IV aGvHD. c The 1-year CIs of cGvHD
Fig. 4
Fig. 4
Clinical outcomes after Haplo-PBSCT-Cord. a The 1-year probability of relapse. b The 1-year probability of disease-free survival (DFS) and overall survival (OS)
See this image and copyright information in PMC

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