Actively Recruiting
Radiotherapy Followed by Tiselizumab Combined With RCHOP in Previously Untreated Bulky Follicular Lymphoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-11-26
20
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This was a single center, single arm, phase II study. Patients with previously untreated follicular lymphoma were enrolled from the department of lymphoma, Tianjin Medical University Cancer Institute and Hospital. The bulky disease was received radiation (dose:18～24Gy) before RCHOP. Patients began chemoimmunotherapy 1～2 weeks later than radiation. Treatment included Tiselizumab (200 mg iv d1) plus R-CHOP (rituximab 375 mg/m2 intravenous \[IV\] day 2, cyclophosphamide 750 mg/m2 IV day 3, doxorubicin 50 mg/m2 IV day 3, vincristine 1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3, and prednisone 100 mg oral days 3-7, 21～28 days for one cycle ) for six cycles. Rituximab was given every 2 months to patients who were complete metabolic response /partial metabolic response（CMR/PMR）after first-line chemo until 2 years. Response was assessed by PET/CT scan after cycle 4 and cycle 6.
CONDITIONS
Official Title
Radiotherapy Followed by Tiselizumab Combined With RCHOP in Previously Untreated Bulky Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD20 positive follicular lymphoma, grade 1, 2, or 3a, with bulky disease (mass diameter �3E�3D 7 cm)
- No prior systemic treatment for lymphoma
- Meet Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for starting treatment
- Age between 18 and 75 years
- ECOG Performance Status of 0 to 2
- Stage II, III, or IV by Ann Arbor staging system
- Adequate organ function: WBC �3E�3D 3.5 x10^9/L, platelets �3E�3D 75 x10^9/L, ANC �3E�3D 1.0 x10^9/L, hemoglobin �3E�3D 80 g/L
- Renal function: creatinine clearance �3E�3D 50 mL/min
- Liver function: bilirubin �3C�3D 1.5 x upper limit of normal, AST/ALT �3C�3D 2.5 x upper limit of normal
- Females of childbearing potential must agree to use contraception or abstain from vaginal intercourse during the study and for 6 months after last dose
- Males able to father a child must agree to abstain
- Life expectancy of at least 6 months
- Provide informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Known active central nervous system lymphoma or leptomeningeal disease
- Evidence of diffuse large B-cell transformation
- Grade 3b follicular lymphoma
- Concurrent or recent malignancy within last 3 years, except certain in situ or non-treatment cancers
- Known history of HIV, active hepatitis B or C infection, or any uncontrolled active significant infection
- Known pneumonia related to idiopathic pulmonary fibrosis or drug-induced pneumonia
- Serious neurological or psychiatric conditions preventing normal study participation
- Left ventricular ejection fraction less than 50%
- New York Heart Association class 3 or 4 cardiac disease
- Investigator deems the patient ineligible for enrollment
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
H
Huilai Zhang, MD,PhD
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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