Radiotherapy Followed by Tiselizumab Combined With RCHOP in Previously Untreated Bulky Follicular Lymphoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06704555
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • radiation therapy — RADIATION
    received radiation (dose:18～24Gy)
  • Tiselizumab — DRUG
    200 mg iv day 1
  • Rituximab — DRUG
    375 mg/m2 intravenous \[IV\] day 2
  • Cyclophosphamide — DRUG
    750 mg/m2 IV day 3
  • Doxorubicin — DRUG
    50 mg/m2 IV day 3
  • Vincristine — DRUG
    1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3
  • Prednisone — DRUG
    100 mg oral days 3-7

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Treatment arm
    Radiation (dose:18～24Gy) ，chemoimmunotherapy 1～2 weeks later than radiation. Tiselizumab (200 mg iv d1) 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.

Primary Outcome Measure

Best Complete response (CR) rate [ Time Frame: Through completion of treatment (estimated to be 2.5 year) ]

Central Contacts

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