Actively Recruiting
Phase 2 Study Evaluating Trilaciclib with R-CHOP Chemotherapy in Patients with Diffuse Large B-Cell Lymphoma
Led by Sun Yat-sen University · Updated on 2024-08-26
38
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Trilaciclib combined with chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL). This phase II, single-arm, multi-center study aims to assess whether Trilaciclib can protect bone marrow from damage caused by chemotherapy and improve treatment outcomes. The primary focus is on reducing severe neutropenia, a condition of low white blood cells that can result from chemotherapy. Participants receive Trilaciclib at a dose of 240 mg/m2 on day 1, given within four hours before each chemotherapy session. The chemotherapy regimen used is R-CHOP, which includes rituximab, cyclophosphamide, doxorubicin or epirubicin, vincristine, and prednisone. Patients undergo six treatment cycles, each lasting 21 days, with Trilaciclib administered prior to each cycle. During the study, patients will undergo regular monitoring for side effects and treatment responses. Researchers will track the occurrence of severe neutropenia and other blood-related protective effects over six months. Additional assessments include overall response rate and survival outcomes up to two years. Safety will be closely observed using standard guidelines. The total participation duration covers the treatment and follow-up periods to evaluate both short- and long-term effects.
CONDITIONS
Brief 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...
- Understand the study and agree to sign the informed consent form
- Age 18 years or older, any gender
- Newly diagnosed, untreated diffuse large B-cell lymphoma with at least one measurable tumor
- IPI score between 0 and 2
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- No use of certain supportive drugs or blood transfusions within 1 week before screening
- Estimated survival longer than 3 months
- Adequate organ function
- Willing and able to comply with study visits and procedures
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 3 months after the study
You will not qualify if you...
- Participation in other interventional clinical studies
- Previous or current other cancers
- Lymphoma invading bone marrow
- Symptomatic brain metastases needing immediate treatment
- Known allergy to study drugs or their components
- Prior hematopoietic stem cell or bone marrow transplant
- Active infections needing systemic treatment
- Uncontrolled heart symptoms or diseases
- Severe infection or unexplained fever above 38.5°C before starting treatment
- Radiotherapy within 2 weeks before study drug
- Use of investigational drugs within 4 weeks before study drug
- Live vaccines within 4 weeks before or possibly during the study (flu vaccine allowed in season)
- Pregnant or breastfeeding women
- Any other condition that investigator judges exclusion is necessary
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive Trilaciclib combined with R-CHOP chemotherapy in cycles to treat diffuse large B-cell lymphoma.
6 treatment cycles with dosing on Day 1 of each cycle and prednisone given Days 1-5 per cycle
Duration - Up to 6 months post-treatment
Participants are monitored for safety, efficacy, and adverse events after completing treatment.
Regular visits during follow-up period to assess outcomes and adverse events
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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