- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05050630
Phase II Trial of Tirelizumab Combined With R2-ICE Regimen in the Treatment of rrDLBCL/HGBL
September 10, 2021 updated by: Huang Wenrong, Affiliated Hospital to Academy of Military Medical Sciences
A Perspective and Multicenter Phase II Trial of Tirelizumab Combined With R2-ICE Regimen (Rituximab, Lenalidomide, Ifosfamide, Carboplatin, Etoposide) in the Treatment of Refractory or Relapse DLBCL or HGBL
This study was a prospective, multi-center, single-arm, Phase II clinical study.
Compared with the literature data, objective response rate (ORR) and complete response rate (CR) were the primary endpoint, and 1-year and 2-year progression-free survival (PFS) and 2-year overall survival (OS) were the secondary endpoint.
To evaluate the efficacy and safety of TR2-ICE sequential Tirelarizin, lenalidomide alone, or both maintenance therapy in the rescue of patients with relapsed and refractory diffuse large B or high-grade B-cell lymphoma.
Study Overview
Status
Recruiting
Conditions
- Age Range ≥16 Years, Gender Unlimited
- Histopathology Confirmed Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma
- Received Prior First-line Chemotherapy for DLBCL or HGBL, Failed to Reach CR for Four Cycles, or Relapsed
- At Least One Positive Lesion According to the 2014 Lugano Criteria for Hodgkin's and Non-Hodgkin's Lymphoma
- ECOG Physical Status Score is 0-3
- The Researchers Judged That Life Expectancy Was at Least Three Months
- Understand and Voluntarily Sign Written Informed Consent
Intervention / Treatment
Detailed Description
All patients eligible for inclusion were treated with TR2-ICE, and the first efficacy evaluation was conducted after the second course of treatment.
If the patient can achieve complete response (CR), partial response (PR), and disease stability (SD), the clinical benefit is considered, and the TR2-ICE treatment regimen is continued.
The second efficacy assessment was performed after the 4th course of treatment.
If patients achieved complete response (CR) or partial response (PR) compared to baseline, the clinical treatment was considered effective and the TR2-ICE treatment regimen was continued.
After the completion of six courses of induction chemotherapy, an end-of-course assessment was performed.
Patients with CR and PR can choose to undergo autologous hematopoietic stem cell transplantation consolidation therapy, or lenalidomide or Tirelarizin monotherapy or both combination maintenance therapy.
If patients still had SD after four courses of treatment or PD at any time during the study, they were dropped out of the study and given salvage therapy.
Study Type
Interventional
Enrollment (Anticipated)
73
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xilin Chen, Dr.
- Phone Number: 861066947167
- Email: chenxl307@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Recruiting
- Hospital 307
-
Contact:
- Xilin Chen, Dr.
- Phone Number: 861066947167
- Email: chenxl307@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range ≥16 years old, no gender limitation;
- Diffuse large B-cell lymphoma or high-grade B-cell lymphoma (HGBL) was confirmed by histopathology.
- Have received prior first-line chemotherapy for DLBCL or HGBL, failed to reach CR in four cycles, or relapsed.
- At least one positive lesion under 18F-deoxyglucose (18FDG) positron emission computed tomography (PET-CT) according to the 2014 Lugano criteria for Hodgkin's and non-Hodgkin's lymphoma;
- ECOG physical status score is 0-3;
- At the time of screening, laboratory tests met the following criteria, unless the investigator could determine that lymphoma was the cause (no corrective and supportive treatment for the parameters described below was performed within 2 weeks prior to evaluation) : (1) Routine blood test: Hemoglobin (Hb) ≥90g/L, absolute neutrophil (ANC) ≥1.5×109/L, platelet count (PLT) ≥90×109/L; (2) biochemical examination: serum creatinine (Cr) ≤1.5× upper limit of normal value (ULN), creatinine clearance rate > 50ml/min (Cockcroft formula); Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (liver metastasis: ≤5ULN).
- Life expectancy was at least three months, the researchers judged;
- Understand and voluntarily sign written informed consent.
Exclusion Criteria:
- With central nervous system metastasis or piameningeal metastasis;
- Prior organ transplant;
- Previous or current combination of other malignant tumors, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix;
- Patients who have been treated with PD-1 inhibtor before;
- History of severe allergy to antibody drugs;
- Those with active immune diseases, such as systemic lupus erythematosus;
- Uncontrolled or significant cardiovascular disease, including: (1) New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment, or left ventricular ejection fraction (LVEF) <50% at the time of screening within 6 months prior to initial administration of the study drug; (2) primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, unshaped cardiomyopathy); (3) clinically significant prolonged history of QTc interval, or screening QTc interval >470ms for women and >450ms for men; (4) symptomatic coronary heart disease requiring drug treatment during screening period; (5) Other cardiovascular diseases deemed unsuitable for inclusion by the investigator.
- A history of severe interstitial lung disease (ILD), such as pulmonary fibrosis, or baseline chest CT or MRI showing evidence of ILD;
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;
- High-risk surgery for vital organs or poor healing of other surgical wounds as determined by the investigator 6 weeks prior to screening;
- Active infection or active or uncontrolled HBV, HCV infection, HIV/AIDS (Acquired Immune Deficiency Syndrome) or other serious infectious diseases (including: active infection requiring systemic treatment; HBV/HCV/HIV qualitative detection is preferred, quantitative detection is required; HBV DNA can be included after treatment to turn negative);
- Any mental or cognitive impairment that may limit their understanding of informed consent, performance of informed consent, and compliance with the study;
- Drug and alcohol abuse;
- Women of reproductive age who are unwilling or unable to use an effective method of contraception during the entire treatment period of the trial and within 12 weeks of the last Tirelizu administration or within 12 months of the last rituximab administration, whichever is the latest [women of reproductive age include: Any woman who has menstruated and has not undergone successful artificial sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or has not been menopausal], is pregnant or breastfeeding;
- Other conditions that the investigator considers inappropriate for participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TR2-ICE
All patients eligible for inclusion were treated with TR2-ICE, and the first efficacy evaluation was conducted after the second course of treatment.
If the patient can achieve complete response (CR), partial response (PR), and disease stability (SD), the clinical benefit is considered, and the TR2-ICE treatment regimen is continued.
The second efficacy assessment was performed after the 4th course of treatment.
If patients achieved complete response (CR) or partial response (PR) compared to baseline, the clinical treatment was considered effective and the TR2-ICE treatment regimen was continued.
After the completion of six courses of induction chemotherapy, an end-of-course assessment was performed.
Patients with CR and PR can choose to undergo autologous hematopoietic stem cell transplantation consolidation therapy, or lenalidomide or Tirelarizin monotherapy or both combination maintenance therapy.
|
Rituximab 375 mg/m2 d0; Lenalidomide 25mg/d d1-10; Ifosfamide 5g/m2 d2; Carboplatin calculate according to AUC=5 (single dose ≤800 mg); Etoposide 100mg/m2 d1-3; Tirelizumab 200mg d6.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Main purpose
Time Frame: Enrollment is expected to last for one year, followed up for two years.
|
Compared with the literature data, objective response rate (ORR) and complete response rate (CR) were the primary endpoint
|
Enrollment is expected to last for one year, followed up for two years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2021
Primary Completion (ANTICIPATED)
July 30, 2022
Study Completion (ANTICIPATED)
July 30, 2023
Study Registration Dates
First Submitted
September 10, 2021
First Submitted That Met QC Criteria
September 10, 2021
First Posted (ACTUAL)
September 20, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 10, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307-947168-98
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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