Clinical trial NCT05351346: Genotype-guided Treatment in DLBCL
Official title: A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital, Sichuan
name: Qilu Hospital of Shandong University
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Wuhan Union Hospital, China
name: The Second Hospital of Anhui Medical University
name: Zhongda Hospital
name: The First Affiliated Hospital of Soochow University
name: China-Japan Friendship Hospital
name: Tongji Hospital
name: Beijing Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Zhujiang Hospital
name: The First Affiliated Hospital of Anhui Medical University North District
name: Hunan Cancer Hospital
name: Liaoning Cancer Hospital & Institute
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Cancer Hospital Affiliated to Xinjiang Medical University
name: The First Affiliated Hospital of Xiamen University
name: The First Affiliated Hospital of Nanchang University
name: LanZhou University
name: Central South University
name: The Affiliated Hospital of Xuzhou Medical University
name: Yunnan Cancer Hospital
name: Henan Cancer Hospital
name: Fujian Medical University Union Hospital
name: The First Hospital of Jilin University
name: The First Affiliated Hospital of Anhui Medical University
name: Gansu Cancer Hospital
name: The First Affiliated Hospital of University of Science and Technology of China
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Shandong Cancer Hospital and Institute
name: Affiliated Cancer Hospital of Harbin Medical University
name: First Affiliated Hospital of Chongqing Medical University
name: Fudan University
name: Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Pekcing Union Medical College
name: Affiliated Hospital of Nantong University
name: Yunnan First People's Hospital
name: Shanxi Province Cancer Hospital
name: Fifth Affiliated Hospital of Guangzhou Medical University
name: Beijing Tongren Hospital
name: First Affiliated Hospital of Harbin Medical University
name: Ruian People's Hospital
name: Harbin Institute of Hematology
name: The First Affiliated Hospital of Guangzhou Medical University
name: Affiliated Hospital of Guilin Medical College
name: Air Force Military Medical University, China
name: The Affiliated Zhongshan Hospital of Dalian University
name: Yantai Yuhuangding Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Peking University Third Hospital
First posted: 2022-04-28
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
* Availability of archival or freshly collected tumor tissue before study enrolment
* International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy greater than or equal to (\>/=) 6 months
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research

Exclusion Criteria:

* Previous chemotherapy.
* Previous stem cell transplantation.
* History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Patients with central nervous system (CNS) lymphoma
* Primary mediastinal large B-cell lymphoma
* Left ventricular ejection fraction\<50%
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

  1. Neutrophils\<1.5×10\^9/L
  2. Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
  3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
  4. Creatinine is 1.5 times higher than the ULN.
* HIV-infected patients
* Positive test results for chronic hepatitis B and hepatitis C infection
* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
* Pregnant or lactation
* Require treatment with strong/moderate CYP3A inhibitors or inducers.
* Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
* Other medical conditions determined by the researchers that may affect the study

Primary outcomes:
measure: Progression-free survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
Secondary outcomes:
measure: Complete response rate
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: From enrollment to study completion, a maximum of 4 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: