BridgeMD
New treatment option for Diffuse Large B Cell Lymphoma
Official title Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT05348213
What this study is testing
What is Zanubrutinib plus R-ICE?
Zanubrutinib plus R-ICE is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b cell lymphoma.
Also referred to as ZR-ICE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- DLBCL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and...
- 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...
- 18≤ age ≤75 years old, male and female;
You likely can't join 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...
- people 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...
- Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure...
- Lymphoma with central nervous system (CNS) involvement;
See the full eligibility criteria
- 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...
- 18≤ 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...
- 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...
- 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...
- 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;
- people 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...
- 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...
- With severe infection;
- Substance abuse, medical, psychological, or social conditions that may interfere with the people' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.