Actively Recruiting
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
Led by Sun Yat-sen University · Updated on 2024-08-26
38
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Trilaciclib in DLBCL patients treated with R-CHOP.
CONDITIONS
Official Title
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to understand the study and sign informed consent
- Age 18 years or older, any gender
- Treatment-naive, histologically confirmed DLBCL with at least one measurable tumor
- International Prognostic Index (IPI) score between 0 and 2
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- No use of prophylactic growth factors, platelet or blood transfusion within 1 week before screening
- Estimated survival greater than 3 months
- Adequate organ function
- Willing and able to comply with study visits, treatment, and laboratory exams
- Women of childbearing potential must have a negative pregnancy test within 3 days before first dose
- Participants of childbearing potential must agree to use highly effective contraception during the study and for 3 months after last dose
You will not qualify if you...
- Participation in other interventional clinical studies
- Previous or concurrent other cancers
- Lymphoma involving the bone marrow
- Symptomatic brain metastases needing immediate radiotherapy or steroid treatment
- Known allergy to study drugs or ingredients
- Previous hematopoietic stem cell or bone marrow transplant
- Active infection requiring systemic treatment
- Uncontrolled heart symptoms or diseases
- Severe active infection or unexplained fever above 38.5°C during screening or before first dose (except tumor fever)
- Radiotherapy within 2 weeks before study medication
- Use of any investigational drug within 4 weeks before study medication
- Live attenuated vaccine within 4 weeks before study medication or during study (except influenza vaccine during flu season)
- Pregnant or breastfeeding women
- Any conditions that investigators believe warrant exclusion from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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