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4958 Outcomes and Prognostic Factors of Second Allogeneic Hematopoietic Cell Transplantation in Patients with Acute Lymphoblastic Leukemia: A Study from the Adult Acute Lymphoblastic Leukemia Working Group of the Japanese Society for Transplantation and Cellular Therapy

Program: Oral and Poster Abstracts
Session: 723. Allogeneic Transplantation: Long-term Follow-up and Disease Recurrence: Poster III
Hematology Disease Topics & Pathways:
Research, Clinical Research, registries
Monday, December 11, 2023, 6:00 PM-8:00 PM

Kimimori Kamijo1*, Yoshimitsu Shimomura2*, Takayoshi Tachibana, MD, PhD3*, Yuho Najima, MD, PhD4, Jun Aoki, MD, PhD5*, Yu Akahoshi, MD, PhD6*, Masatsugu Tanaka, M.D., Ph.D.3*, Noriko Doki, MD, PhD7, Naoyuki Uchida, MD, PhD8, Hiroyuki Ohigashi, MD, PhD9*, Hikaru Kobayashi10*, Shuichi Ota, MD11, Miho Nara12*, Shinichiro Fujiwara, MD, PhD13*, Yasuo Mori, M.D., Ph.D.14,15*, Yoshinobu Kanda16*, Tatsuo Ichinohe17*, Yoshiko Atsuta, MD, PhD18* and Yasuyuki Arai, MD, PhD19,20

1Department of Hematology, Rinku General Medical Center, Izumisanoshi, HYO, Japan
2Department of Hematology, Kobe City Hospital Organization, Kobe, Japan
3Department of Hematology, Kanagawa Cancer Center, Kanagawa, Japan
4Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, TKY, Japan
5Department of Hematology, Kanto Rosai Hospital, Kawasaki, Japan
6Icahn School of Medicine at Mount Sinai, New York, NY
7Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan
8Department of Hematology, Toranomon Hospital, Tokyo, Japan
9Department of Hematology, Hokkaido University Hospital, Sapporo, HOK, JPN
10Department of Hematology, Nagano Red Cross Hospital, Nagano, Japan
11Sapporo Hokuyu Hospital, Sapporo, JPN
12Center for Transfusion Cell Therapy, Transplantation and Regenerative Medicine, Akita University Hospital, Akita, JPN
13Division of Hematology, Department of Medicine, Jichi Medical University, Tochigi, Japan
14Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medicine, Fukuoka, Japan
15Hematology, Oncology & Cardiovascular medicine, Kyushu University Hospital, Fukuoka, JPN
16Division of Hematology, Jichi Medical University Saitama Medical Center, Saitama, Japan
17Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan
18Japanese Data Center For Hematopoietic Cell Transplantation, Nagakute, Japan
19Kyoto University, Kyoto, JPN
20Department of Hematology, Kyoto University Hospital, Kyoto, Japan


Allogeneic hematopoietic cell transplantation (allo-HCT) is a curative treatment option frequently used in patients with acute lymphoblastic leukemia (ALL). However, relapse after allo-HCT remains the main concern because it is associated with poor outcomes, with a long-term survival rate < 10 %. There is no standard treatment for patients with ALL who relapsed after allo-HCT.

Second allo-HCT (allo-HCT2) is a curative treatment option for patients with ALL who relapsed after the first allo-HCT (allo-HCT1). However, data on allo-HCT2 in patients with ALL are limited, and the indications and outcomes of allo-HCT2 are unclear.

Therefore, this study aimed to investigate the outcomes and prognostic factors of patients who underwent allo-HCT2 after ALL relapse.


This study included 425 adult patients with ALL who underwent allo-HCT2 after relapse between January 2001 and December 2020. The primary endpoint was 2-year overall survival (OS), which was evaluated using the log-rank test. Prognostic factors for the primary endpoint were evaluated using the multivariable Cox proportional hazards model. The variables considered in the Cox proportional hazards model are listed in the Table. The impacts of the candidate factors are shown as hazard ratios (HRs) and 95% confidence intervals (CIs). Additionally, we performed an analysis stratified by disease and disease status because Philadelphia chromosome (Ph)-positive B-ALL could affect the treatment and disease status at allo-HCT2 and the outcome.


The median age at allo-HCT2 was 36 years (interquartile range; 27–48 years) and 220 patients (52%) were male. According to the Eastern Cooperative Oncology Group, 94 patients (22%) had a performance status of > 2. There were 235 patients (55%) with Ph-negative B-ALL, 122 patients (29%) with Ph-positive B-ALL, and 68 patients (16%) with T-ALL. Regarding disease status at allo-HCT2, 217 patients (51%) had any complete response (CR). One hundred forty-eight patients (35%) received myeloablative conditioning regimen. Ninety patients (21%) received related bone marrow (BM) or peripheral blood (PB) transplantation, 137 patients (32%) received unrelated BM or PB transplantation, and 198 patients (47%) received unrelated cord blood (CB) transplantation.

The median observation time of survivor after allo-HCT2 was 22.3 (interquartile range; 6.3–82.5) months and 2-year OS was 28.0% (95% CI, 23.7–32.4). After stratified disease and disease status, the 2-year OS was 56.5% (95% CI, 44.6–66.8), 31.7% (95% CI, 24.0–39.7), 21.5% (95% CI, 10.6–34.9), and 13.1% (95% CI, 8.4–18.8) in any CR (Ph-positive B-ALL), any CR (other), active disease (Ph-positive B-ALL), and active disease (other), respectively (P < 0.001) (Figure).

In multivariable analysis, Ph-positive B-ALL (HR, 0.48; 95% CI, 0.36–0.65; P < 0.001), tacrolimus-based GVHD prophylaxis at allo-HCT2 (HR, 0.72; 95% CI, 0.54–0.95; P = 0.022) were identified as significantly positive prognostic factors for 2-year OS, while allo-HCT1 to allo-HCT2 < 12 months (HR, 1.38; 95% CI, 1.02–1.88; P = 0.038), relapse within 12 months after allo-HCT1 (HR, 1.37; 95% CI, 1.01–1.85; P = 0.043), ECOG PS > 2 (HR, 1.89; 95% CI, 1.44–2.49; P < 0.001), active disease at allo-HCT2 (HR, 1.88; 95% CI, 1.46–2.42; P < 0.001), unrelated BM or PB transplantation at allo-HCT2 (HR, 1.78; 95% CI, 1.22–2.59; P = 0.003), and CB transplantation at allo-HCT2 (HR, 1.54; 95% CI, 1.09–2.18; P = 0.013) were identified as significantly negative prognostic factors for 2-year OS.


In this study, we demonstrate that the 2-year OS was 28.0% in patients with ALL who underwent allo-HCT2 and identified the prognostic factors that may guide patients to benefit from allo-HCT2.

Disclosures: Najima: Nippon Shinyaku Co., Ltd.: Speakers Bureau; Sumitomo Pharma Co., Ltd.: Speakers Bureau; Takeda Pharmaceutical Company Limited.: Speakers Bureau; Daiichi Sankyo Co. Ltd.: Consultancy, Speakers Bureau; AbbVie GK: Speakers Bureau; Amgen Inc.: Speakers Bureau; Bristol-Myers Squibb K.K.: Speakers Bureau; Chugai Pharmaceutical Co., Ltd.: Speakers Bureau; CSL Behring K.K.: Speakers Bureau; Janssen Pharmaceutical K.K.: Speakers Bureau; Novartis Pharma K.K.: Speakers Bureau; Kyowa Kirin Co., Ltd.: Speakers Bureau; Otsuka Pharmaceutical Co., Ltd.: Speakers Bureau; Astellas Pharma Inc.: Consultancy, Speakers Bureau. Tanaka: Sumitomo Pharma: Speakers Bureau; Otsuka Pharmaceutical: Speakers Bureau; MSD: Speakers Bureau; Kyowa-Kirin: Speakers Bureau; Daiichi Sankyo: Speakers Bureau; Chugai Pharmaceutical: Speakers Bureau; Astellas Phrama: Speakers Bureau; Asahi Kasei Pharma: Speakers Bureau; Abbvie: Speakers Bureau; Pfizer: Speakers Bureau. Doki: Novartis Pharma K.K.: Honoraria; Janssen Pharmaceutical K.K.: Honoraria. Ota: Janssen: Speakers Bureau; Bristol Myers Squibb: Speakers Bureau; Novartis: Speakers Bureau; Amgen: Speakers Bureau; AstraZeneca: Speakers Bureau. Kanda: Towa Pharma: Speakers Bureau; AbbVie: Research Funding, Speakers Bureau; CSL Behring: Speakers Bureau; Japan Blood Products Organization: Research Funding, Speakers Bureau; Otsuka Pharmaceutical: Research Funding, Speakers Bureau; AstraZeneca: Speakers Bureau; Human Life CORD: Speakers Bureau; Sumitomo Pharma: Research Funding, Speakers Bureau; Amgen: Speakers Bureau; Takeda Pharmaceutical: Research Funding, Speakers Bureau; Meiji Seika Pharma: Speakers Bureau; Asahi Kasei Pharma: Research Funding, Speakers Bureau; Daiichi Sankyo: Research Funding, Speakers Bureau; Saitama Hokeni Kyokai: Speakers Bureau; MSD: Speakers Bureau; Kyowa Kirin: Research Funding, Speakers Bureau; Janssen Pharmaceutical: Speakers Bureau; Sanofi: Speakers Bureau; Pfizer: Speakers Bureau; Chugai Pharmaceutical: Research Funding, Speakers Bureau; Novartis: Speakers Bureau; Bristol Myers Squibb: Speakers Bureau; Nippon Shinyaku: Speakers Bureau; Eisai: Research Funding, Speakers Bureau; Shionogi Pharma: Research Funding; Precision: Speakers Bureau; Alexion Pharma: Speakers Bureau; FUJIFILM Wako Pure Chemical: Speakers Bureau; Wakunaga Pharmaceutical: Speakers Bureau; Taiho Pharmaceutical: Research Funding; Nippon Kayaku: Research Funding; JCR Pharmaceuticals: Research Funding. Atsuta: Otsuka Pharmaceutical Co., Ltd: Speakers Bureau; JCR Pharmaceuticals Co., Ltd.: Consultancy; CHUGAI PHARMACEUTICAL CO., LTD.: Speakers Bureau; Novartis Pharma KK: Speakers Bureau; Meiji Seika Pharma Co, Ltd.: Honoraria.

*signifies non-member of ASH