Evidence map›Paper›PMID 39468701›Full record

Trial reportJournal of hematology & oncology2024

Tucidinostat plus pediatric-inspired chemotherapy for newly diagnosed adult ETP-ALL/LBL: a single-arm, phase 2 trial.

Jieping Lin, Zicong Huang, Zihong Cai, Jia Li, Zhen Li, Chenhao Ding, Zhixiang Wang, Xiaofang Li, Xuan Zhou, Bailin He and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IILetter
In one paragraph

Trial report in Journal of hematology & oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03553238 (An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03553238 phase2 / phase3unknown statusnot on this map

An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2016 to 2020Enrolled70ConditionsLeukemia, Acute, Leukemia, T Cell, Leukemia, LymphoblasticArmsChidamide, Dexamethasone, vincristine, Cyclophosphamide, Idarubicin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jieping Lin *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Zicong Huang *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Zihong Cai *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Jia Li *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Zhen Li *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Chenhao Ding *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Zhixiang WangDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Xiaofang LiDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Xuan ZhouDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Bailin HeDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Wenhao ZhongDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Li XuanDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Qifa LiuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Yang XuNational Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Hongsheng ZhouDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. zhs1@i.smu.edu.cn.

Funding

National Key Research and Development Program of China 2022YFC2502600-5National Key Research and Development Program of China 2022YFC2502700National Natural Science Foundation of China 82170163
6 · The paper itself

Abstract

Early T-cell precursor lymphoblastic leukemia/lymphoma (ETP-ALL/LBL) is a distinct subtype of T-ALL/LBL, characterized by a poor response to initial chemotherapy, a high relapse rate, and an inferior outcome. The treatment options for ETP-ALL/LBL are currently limited, and there are no reported clinical trials available for ETP-ALL/LBL. From June 2018 to June 2022, we conducted a single-arm, single-center, phase 2 trial (NCT03553238) in newly diagnosed ETP-ALL/LBL (age 14-55). Patients (N = 54) received pediatric-inspired chemotherapy plus tucidinostat, which was orally administered once daily at a dosage of 10 mg from induction to consolidation therapy. The primary endpoint was 3 year event-free survival (EFS). Secondary endpoints were overall survival (OS), relapse-free survival (RFS), complete remission rate and adverse events. The composite complete remission (CRc, complete response [CR] plus complete response with incomplete blood count recovery [CRi]) rate and MRD negativity after induction therapy was 91% (49 of 54 patients) and 65% (35 of 54 patients), respectively. The MRD negativity after consolidation was achieved in 87% patients (47 of 54 patients). With a median follow-up of 39.3 months (IQR, 20.6 to 60.0), the 3 year EFS rate was 67.7% (95% CI 56.2-81.7), the 3 year OS rate was 71.5% (95% CI 60.2-84.9) and the 3 year RFS rate was 67.5% (95% CI 55.9-81.6). The most common grade 3-4 adverse events were neutropenia (94%), anemia (85%), thrombocytopenia (76%), and infection (53%). Tucidinostat plus pediatric regimen is an effective and well-tolerated regimen for new diagnosed ETP-ALL/LBL, with high CRc and MRD negativity rates, as well as encouraging survival outcomes.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsPrecursor T-Cell Lymphoblastic Leukemia-LymphomaAdolescentAdultFemaleHumansMaleMiddle AgedRemission InductionYoung AdultEarly T-cell precursor lymphoblastic leukemia/lymphomaHistone deacetylase inhibitorTucidinostat

Identifiers

PMID39468701
PMCPMC11514739

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.