Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma
R-ICE+X
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
1 other identifier
interventional
76
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedStudy Start
First participant enrolled
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedOctober 23, 2024
October 1, 2024
3 years
January 10, 2022
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At the end of cycle 3 (each cycle is 21 days)
Secondary Outcomes (4)
Objective remission rate after 3 cycle chemotherapy
At the end of cycle 3 (each cycle is 21 days)
2 year progression free survival
Baseline up to data cut-off (up to approximately 2 years)
2 year overall survival
Baseline up to data cut-off (up to approximately 2 years)
Chemotherapy-related adverse reactions
At the end of cycle 3 (each cycle is 21 days)
Study Arms (1)
R-ICE+X
EXPERIMENTALR-ICE plus novel targeted drugs
Interventions
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 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 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 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 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
Eligibility Criteria
You may qualify if:
- 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;
- ≤ age ≤75 years old, male and female;
- ECOG 0-2 points;
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 10, 2022
First Posted
April 27, 2022
Study Start
May 16, 2022
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share