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2407 Daratumumab and Venetoclax-Containing Regimens in the Management of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation in Hematological Malignancies

Program: Oral and Poster Abstracts
Session: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster II
Hematology Disease Topics & Pathways:
Leukemia, ALL, AML, Diseases, Lymphoma (any), Non-Biological, drug-drug interaction, Therapies, Combinations, Non-Hodgkin Lymphoma, chemotherapy, T-Cell Lymphoma, Lymphoid Malignancies, Myeloid Malignancies, Clinically relevant
Sunday, December 6, 2020, 7:00 AM-3:30 PM

Fan Yang1*, Zhihui Li, MD2*, Changwei Dong, MD3*, Yang LEI, MD4*, YanPing Geng, MD4*, XiaoPei Wen, MD4*, Yan Zhou, MD4* and Tong Wu, MD1

1Bone Marrow Transplantation, Beijing Boren Hospital, Beijing, China
2Department of Hematology, Beijing Boren Hospital, Beijing, CHN
3Bone Marrow Transplantation, Beijing borenhospital, Beijing, China
4Bone Marrow Transplantation, Beijing Borenhospital, Beijing, China

Background: The prognosis of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematological malignancies is poor with conventional therapies such as immunosuppressant withdrawal, interferon, chemotherapy, donor lymphocyte infusion and second allo-HSCT. Immunotherapy and targeted therapy may bring new hope for this setting.

Objective: In current study, the safety and efficacy of daratumumab and venetoclax-containing regimens in the management of relapse after allo-HSCT in hematological malignancies were evaluated.

Methods: From August 2019 to May 2020, 12 patients with hematological malignancies who relapsed after allo-HSCT were included. The median age was 26 (5-49) years old. The diagnosis included acute myeloid leukemia (AML, n=3), acute lymphoblastic leukemia (B-ALL, n=2), T lymphoblastic lymphoma/leukemia (T-LBL, n=6) and B lymphoblastic lymphoma/leukemia (B-LBL, n=1). The disease status before transplant was complete remission (CR) in 8 cases (minimal residual disease (MRD)+ in 4, MRD- in 4), partial remission (PR) in 1 case and recurrence in 3 cases. The types of transplant were haploidentical in 6 cases (50%), unrelated in 5 cases (41.7%) and matched sibling in 1 case (8.3%). Myeloablative conditioning regimens were used and GVHD prophylaxis was with cyclosporine, short-term methotrexate and mycophenolate mofetil. Anti-thymocyte globulin was applied in haploidentical and unrelated transplants. The median relapse time was 4 (1-10) months after HSCT and the pattern of relapse included hematologic relapse in 11 cases (91.7%), and MRD+ in 1 case (8.3%). The expression of CD38 antigen was detected by flow cytometry. Daratumumab (400mg for children, 800mg for adults at day 0 and 14) and venetoclax (50mg/d, gradually increased to 100-400mg/d, d1-28) were administrated for induction and consolidation therapies.


After 1 cycle of induction therapy, 5 cases achieved CR (41.7%) (4/6 T-LBL, 1/3 AML), 1 case in PR (T-LBL, 8.3%), and 6 cases in non-remission (NR) (2/2 B-ALL, 2/3 AML, 1/1 B-LBL, 1/6 T-LBL, 50%). The median time to achieve CR was 26 (18-42) days. Three of 5 CR patients were treated with daratumumab and venetoclax only, and rest 2 CR patients were treated with daratumumab and venetoclax plus cytarabine (100mg/d for 3-5d) and etoposide (100mg/d for 3-5d). Four patients in CR were consolidated with daratumumab and venetoclax for continuous MRD- CR with the median 263 days(210,335) , while the rest 1 patient in CR underwent the second allo-HSCT.The median consolidation therapies was 2 (1-4) cycles and the interval was 8 weeks. With the median follow-up 236 (138-365) days, eight of 12 patients (66.7%) survived and DFS was 41.7%. Seven patients developed treatment-related neutropenia (58.3%) and 4 patients had infections (33.3%). No severe side effects were noted. No GVHD occurred during treatment with above regimens.

Conclusion: Our pilot clinical study has shown that daratumumab and venetoclax-containing regimens are safe and effective in the management of relapse after allo-HSCT in patients with hematological malignancies. It seems that better response are in T-LBL. It may provide an option for the patients their leukemic cells expressing CD38 with or without chemotherapy-resistant diseases.

[Key words] relapse; allogeneic hematopoietic stem cell transplantation; hematological malignancy; daratumumab; venetoclax

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH