Evidence map›Paper›PMID 42630801›Full record

ArticleJournal of the National Cancer Center2026

Orelabrutinib, fludarabine, cyclophosphamide, and obinutuzumab (OFCG) for first-line treatment of chronic lymphocytic leukemia: a multicenter phase II trial (cwCLL-001 trial).

Yi Miao, Ming Liu, Shuchao Qin, Fei Li, Jin Zhang, Hongling Peng, Chunyan Ji, Luomengjia Dai, Ziyuan Zhou, Chongyang Ding and 10 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the National Cancer Center, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05322733 (Efficacy and Safety of Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05322733 phase2unknown statusnot on this map

Efficacy and Safety of Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (oFCG) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2022 to 2025Enrolled25ConditionsChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaArmsOrelabrutinib, Obinutuzumab, Fludarabine, Cyclophosphamide
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Yi MiaoLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Ming LiuLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Shuchao QinLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Fei LiDepartment of Hematology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Jiangxi Provincial Key Laboratory of Hematological Diseases, Nanchang, China.
Jin ZhangDepartment of Hematology, Sir Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine, Hangzhou, China.
Hongling PengDepartment of Hematology, The Second Xiangya Hospital of Central South University, Changsha, China.
Chunyan JiDepartment of Hematology, Qilu Hospital of Shandong University, Jinan, China.
Luomengjia DaiLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Ziyuan ZhouLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Chongyang DingDepartment of Nuclear Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Zhen WangDepartment of Pathology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Yeqin ShaLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Tonglu QiuLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Hanning TangLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Hui JinLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Lei FanLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Wei XuLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Jianyong LiLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Yi XiaLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.
Huayuan ZhuLymphoma Center, Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This multicenter phase II trial aimed to evaluate the orelabrutinib, fludarabine, cyclophosphamide, and obinutuzumab (OFCG) regimen as first-line therapy for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma without restriction by TP53 aberrations [del(17p) and/or TP53 mutation] and IGHV status. Methods: Eligible patients received OFCG (orelabrutinib, orally 150 mg/day; fludarabine, intravenously 25 mg/m Results: Among 25 enrolled patients, 23 completed 3 cycles of OFCG therapy; of these, 13 patients achieved BM-uMRD4. After 6 cycles, 76.0 % (19/25) achieved BM-uMRD4, and 80 % (20/25) of patients achieved PB-uMRD4. CRR with BM-uMRD4 was achieved by 20.0 % (5/25), 52.0 % (13/25), and 64.0 % (16/25) of patients after 3, 6, and 12 cycles, respectively. Significant differences in BM-uMRD6 at C7D0 (odds ratio [OR], 0.03 [95 % confidence interval [CI]: 0, 0.32]; Conclusion: The study meet the primary endpoint, showing the potential efficacy and acceptable safety profile of the OFCG regimen as a first-line treatment for CLL. Trial registration: NCT05322733.

Indexed as

Chronic lymphocytic leukemiaFirst-line treatmentMinimal residual diseaseOFCG

Identifiers

PMID42630801
PMCPMC13494604

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.