Actively Recruiting
R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Led by oubai, MD/PhD · Updated on 2021-09-16
64
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.
CONDITIONS
Official Title
R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B
- At least one measurable lesion according to Lugano response criteria
- High tumor burden with at least one of: involvement of 3 or more nodal sites (>3 cm each), nodal or extranodal mass >7 cm, hepatomegaly or splenomegaly confirmed by PET-CT (spleen >15 cm female, >16 cm male), pleural or peritoneal effusion, LDH three times upper limit normal, or PET-CT total metabolic tumor volume >220 cm3
- No prior lymphoma treatment
- Age between 18 and 75 years
- ECOG performance status 0 to 2
- IPI score greater than 1 or extranodal mass diameter ≥7 cm
- Life expectancy of at least 6 months
- Left ventricular ejection fraction ≥50%
- Signed informed consent and willingness to comply with study visits, treatment, and tests
You will not qualify if you...
- Pregnant or breastfeeding, or childbearing women not using contraception
- Abnormal liver function: total bilirubin >1.5 times normal; ALT/AST >2.5 times normal without liver metastasis; ALT/AST >5 times normal with liver metastasis
- Abnormal kidney function: serum creatinine >1.5 times normal
- Low neutrophil count (<1.5 x 10^9/L) or low platelet count (<75 x 10^9/L)
- Allergy to any study drug or ingredients
- Significant uncontrolled cardiovascular disease or history
- Mental disorders or inability to give informed consent
- Lymphoma involvement of the central nervous system
- Previous history of other malignant tumors
- HIV infection; HBV infection with HBV-DNA >2000 IU/ml; HCV infection with HCV-RNA >200 IU/ml
- Investigator judgment deeming participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
O
Ou BAI, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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