Age Range ≥16 Years, Gender UnlimitedPhase 2NCT05050630

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

A Phase 2 study testing TR2-ICE in people with Age Range ≥16 Years, Gender Unlimited and Histopathology Confirmed Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: 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
What is being tested?: TR2-ICE
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteChina
Study dates: 1 Aug 2021to 30 Jul 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

wenrong huang, Dr. contact

861066947169

huangwr301@163.com

Xilin Chen, Dr. contact

861066947167

chenxl307@163.com

China1 site, 1 recruiting

Hospital 307
Beijing, Beijing Municipality, 100071
Wenrong Huang, Dr., 861066947169, huangwr301@163.com
Xilin Chen, Dr., 861066947167, chenxl307@163.com
Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

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
Being tested: TR2-ICE
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TR2-ICEDrug
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.

Study groups in NCT05050630
Study group	Role	What they receive
TR2-ICE	Experimental	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. Receives: Drug: TR2-ICE

What is being measured

The primary outcome is the main question the study is designed to answer.

Main purpose
Compared with the literature data, objective response rate (ORR) and complete response rate (CR) were the primary endpoint
Measured: Enrollment is expected to last for one year, followed up for two years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202130 Jul 2023

First posted20 Sep 2021
Study start1 Aug 2021
Primary completion30 Jul 2022 (estimated)
Study completion30 Jul 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Age Range ≥16 Years, Gender UnlimitedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All patients eligible for inclusion were treated with TR2-ICE：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.
Masking: None (open label)
Enrolment: 73 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05050630
Sponsor's protocol ID: 307-947168-98
Status last verified: Sep 2021
First submitted: 10 Sep 2021
Last updated: 20 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05050630
Acronym / sponsor ID: 307-947168-98
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 73 participants (estimated)
Lead sponsor: Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
Collaborators: Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study start: 1 Aug 2021 (actual)
Primary completion: 30 Jul 2022 (estimated)
Study completion: 30 Jul 2023 (estimated)
First posted: 20 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All patients eligible for inclusion were treated with TR2-ICE：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.

Arm	Type	Receives
TR2-ICE	Experimental	Drug: TR2-ICEAll 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TR2-ICERituximab 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.	Drug	TR2-ICE

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

wenrong huang, Dr. contact

861066947169

huangwr301@163.com

Xilin Chen, Dr. contact

861066947167

chenxl307@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact wenrong huang, Dr. (861066947169, huangwr301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main purpose (time frame: Enrollment is expected to last for one year, followed up for two years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05050630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.