Diffuse Large B Cell LymphomaPhase 2R-ICE+XNCT05348213
Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma
A Phase 2 study testing Zanubrutinib plus R-ICE, Decitabine plus R-ICE and Chidamide plus R-ICE in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Zanubrutinib plus R-ICE, Decitabine plus R-ICE and Chidamide plus R-ICE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2022to 1 Jun 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DLBCL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma);
- There are evaluable lesions detected by PET/CT;
- Life expectancy of more than 3 months;
- Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons;
- 18≤ age ≤75 years old, male and female;
- ECOG 0-2 points;
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- No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
- ① Absolute value of neutrophil count ≥1500/mm3; Platelet count ≥75,000/mm3
- ② Total bilirubin ≤2× upper limit of normal value (ULN)
- ③ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate aminotransferase [SGPT]) ≤3× upper limit of normal value (ULN)
- ④ the creatinine clearance rate was ≥60ml/min
- ⑤ No cardiac dysfunction
- If the subject is of reproductive age and requires effective contraception, he/she agrees to comply with all contraceptive requirements: 1) there are fertile women have to decide, at the same time take two reliable contraceptive methods (a kind of high efficient contraceptives - tubal ligation, intrauterine contraceptive device, hormone (birth control pills, needle, patch, vaginal ring or implants) or partner vasectomy, another effective birth control method -- men or synthetic rubber condom, diaphragm or cervical cap). 2) Unless hysterectomy, effective contraception is required even if there is a history of infertility;
- Fertile men must always use rubber or synthetic condoms when having sexual contact with fertile women during the use of this product and within 28 days of discontinuation of this product, even if they have successfully vasectomy; The subjects knew the characteristics of the disease, voluntarily joined the study, received treatment and follow-up, and the informed consent was signed by the subjects themselves or their guardians and impartial witnesses.
Who cannot join
- Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide);
- Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA > detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons;
- Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
- Bone marrow failure, defined as ANC<1500/mm3 or platelet <75,000/mm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow;
- Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction <50%;
- Lymphoma with central nervous system (CNS) involvement;
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- Those who are known to be allergic to the test drug ingredients;
- Those who have received grade II or above surgery within three weeks before treatment;
- Patients who have received organ transplants;
- Has been diagnosed with or is being treated for malignancy other than lymphoma, except for:
- ① They have received therapeutic treatment and have not had known active disease malignancy for ≥5 years prior to enrollment;
- ② Basal cell carcinoma of the skin (except melanoma) without signs of disease after adequate treatment;
- ③ Cervical carcinoma in situ without signs of disease after adequate treatment.
- With severe infection;
- Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020
Weili ZHAO, +862164370045 ext. 610707, zwl_trial@163.com
About this study
Official title: Clinical Study of Efficacy and Safety of Novel Targeted Drugs Combined With R-ICE Regimen in the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma
A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma.
Read the detailed description
Refractory recurrence of patients with diffuse large B cell lymphoma inclusion/exclusion standard subjects in a signed written informed consent, according to the results of genotyping, divided the patients into MCD, TP53, BN2, EZB, ST2, NOS, N1, a total of 7 kinds of types. New targeted drugs were added based on typing results: Zanubrutinib for MCD and BN2, Decitabine for TP53, Chidamide for EZB, Tofacitinib for ST2, and Pomalidomide for N1 and NOS. After 3 courses of treatment, PET-CT was used to evaluate the efficacy. Patients with CR/PR, aged ≤65 years, qualified and willing for transplantation, were treated with autologous hematopoietic stem cell transplantation (ASCT); Patients who did not meet the above requirements or failed to collect autologous hematopoietic stem cells were placed on new targeted drug maintenance therapy for up to 12 months; If patients were evaluated as SD and PD after 3 cycles, they were treated with other regiments. New targeted drugs combined with R-ICE and ASCT were evaluated every 3 months in the first year and every 6 months in the second and third years after treatment.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Zanubrutinib plus R-ICE, Decitabine plus R-ICE, Chidamide plus R-ICE, Tofacitinib plus R-ICE, Pomalidomide plus R-ICE
- Keywords
- Diffuse Large B Cell Lymphoma, R-ICE+X
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib plus R-ICEDrug
Also called ZR-ICE
Zanubrutinib 160mg/bid PO D1-21 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Decitabine plus R-ICEDrug
Also called DR-ICE
Decitabine 10mg/m2 IV D1-5 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Chidamide plus R-ICEDrug
Also called CR-ICE
Chidamide 20mg/d PO D1、4、8、11 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Tofacitinib plus R-ICEDrug
Also called TR-ICR
Tofacitinib 5mg/bid PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Pomalidomide plus R-ICEDrug
Also called PR-ICE
Pomalidomide 4mg/d PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
| Study group | Role | What they receive |
|---|---|---|
| R-ICE+X | Experimental | R-ICE plus novel targeted drugs Receives: Drug: Zanubrutinib plus R-ICE; Drug: Decitabine plus R-ICE; Drug: Chidamide plus R-ICE; Drug: Tofacitinib plus R-ICE; Drug: Pomalidomide plus R-ICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate after 3 cycle chemotherapy
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: At the end of cycle 3 (each cycle is 21 days)
Secondary outcomes (4)
Objective remission rate after 3 cycle chemotherapy
Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: At the end of cycle 3 (each cycle is 21 days)
2 year progression free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
2 year overall survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Chemotherapy-related adverse reactions
Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.
Measured: At the end of cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start16 May 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348213
- Sponsor's protocol ID
- R-ICE+X
- Acronym
- R-ICE+X
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Efficacy and Safety of Novel Targeted Drugs Combined With R-ICE Regimen in the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05348213
- Acronym / sponsor ID
- R-ICE+X / R-ICE+X
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse Large B Cell Lymphoma, R-ICE+X
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Apr 2022 (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.
A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma.
Detailed description
Refractory recurrence of patients with diffuse large B cell lymphoma inclusion/exclusion standard subjects in a signed written informed consent, according to the results of genotyping, divided the patients into MCD, TP53, BN2, EZB, ST2, NOS, N1, a total of 7 kinds of types. New targeted drugs were added based on typing results: Zanubrutinib for MCD and BN2, Decitabine for TP53, Chidamide for EZB, Tofacitinib for ST2, and Pomalidomide for N1 and NOS. After 3 courses of treatment, PET-CT was used to evaluate the efficacy. Patients with CR/PR, aged ≤65 years, qualified and willing for transplantation, were treated with autologous hematopoietic stem cell transplantation (ASCT); Patients who did not meet the above requirements or failed to collect autologous hematopoietic stem cells were placed on new targeted drug maintenance therapy for up to 12 months; If patients were evaluated as SD and PD after 3 cycles, they were treated with other regiments. New targeted drugs combined with R-ICE and ASCT were evaluated every 3 months in the first year and every 6 months in the second and third years after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-ICE+X | Experimental | Drug: Zanubrutinib plus R-ICE, Drug: Decitabine plus R-ICE, Drug: Chidamide plus R-ICE, Drug: Tofacitinib plus R-ICE, Drug: Pomalidomide plus R-ICER-ICE plus novel targeted drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- DLBCL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma);
- There are evaluable lesions detected by PET/CT;
- Life expectancy of more than 3 months;
- Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons;
- 18≤ age ≤75 years old, male and female;
Key exclusion criteria (15 listed)
- Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide);
- Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA > detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons;
- Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
- Bone marrow failure, defined as ANC<1500/mm3 or platelet <75,000/mm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow;
- Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction <50%;
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 |
|---|---|---|
| Zanubrutinib plus R-ICEAlso: ZR-ICEZanubrutinib 160mg/bid PO D1-21 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3 | Drug | R-ICE+X |
| Decitabine plus R-ICEAlso: DR-ICEDecitabine 10mg/m2 IV D1-5 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3 | Drug | R-ICE+X |
| Chidamide plus R-ICEAlso: CR-ICEChidamide 20mg/d PO D1、4、8、11 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3 | Drug | R-ICE+X |
| Tofacitinib plus R-ICEAlso: TR-ICRTofacitinib 5mg/bid PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3 | Drug | R-ICE+X |
| Pomalidomide plus R-ICEAlso: PR-ICEPomalidomide 4mg/d PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×[GFR(ml/min) + 25] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3 | Drug | R-ICE+X |
Primary outcome
Complete response rate after 3 cycle chemotherapy
Time frame: At the end of cycle 3 (each cycle is 21 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
4 secondary outcomes
Objective remission rate after 3 cycle chemotherapy
Time frame: At the end of cycle 3 (each cycle is 21 days)
2 year progression free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2 year overall survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Chemotherapy-related adverse reactions
Time frame: At the end of cycle 3 (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib plus R-ICE, Decitabine plus R-ICE and Chidamide plus R-ICE in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
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 14 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 23 Oct 2024. 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 ZHAO weili (64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate after 3 cycle chemotherapy (time frame: At the end of cycle 3 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.