Phase II Trial of Tirelizumab Combined With R2-ICE Regimen in the Treatment of rrDLBCL/HGBL

  • STATUS
    Recruiting
  • participants needed
    73
  • sponsor
    Affiliated Hospital to Academy of Military Medical Sciences
Send
Updated on 21 September 2021
See if I qualify

Summary

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.

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.

Details
Condition The Researchers Judged That Life Expectancy Was at Least Three Months, Histopathology Confirmed Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma, At Least One Positive Lesion According to the 2014 Lugano Criteria for Hodgkin's and Non-Hodgkin's Lymphoma, Received Prior First-line Chemotherapy for DLBCL or HGBL, Failed to Reach CR for Four Cycles, or Relapsed, Age Range ≥16 Years, Gender Unlimited, Understand and Voluntarily Sign Written Informed Consent, ECOG Physical Status Score is 0-3
Age 16years - 100years
Treatment TR2-ICE
Clinical Study IdentifierNCT05050630
SponsorAffiliated Hospital to Academy of Military Medical Sciences
Last Modified on21 September 2021

Eligibility

 Yes No Not Sure

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) 1.5109/L, platelet count (PLT) 90109/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) 1.5ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5ULN (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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.