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

NCT ID: NCT06704555

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2027-12-30

Brief Summary

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

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

received radiation (dose:18～24Gy)

Tiselizumab

Intervention Type: DRUG

200 mg iv day 1

Rituximab

Intervention Type: DRUG

375 mg/m2 intravenous \[IV\] day 2

Cyclophosphamide

Intervention Type: DRUG

750 mg/m2 IV day 3

Doxorubicin

Intervention Type: DRUG

50 mg/m2 IV day 3

Vincristine

Intervention Type: DRUG

1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3

Prednisone

Intervention Type: DRUG

100 mg oral days 3-7

Interventions

radiation therapy

received radiation (dose:18～24Gy)

Intervention Type: RADIATION

Tiselizumab

200 mg iv day 1

Intervention Type: DRUG

Rituximab

375 mg/m2 intravenous \[IV\] day 2

Intervention Type: DRUG

Cyclophosphamide

750 mg/m2 IV day 3

Intervention Type: DRUG

Doxorubicin

50 mg/m2 IV day 3

Intervention Type: DRUG

Vincristine

1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3

Intervention Type: DRUG

Prednisone

100 mg oral days 3-7

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a，bulky disease (Mass diameter ≥ 7 cm)
• Have had no prior systemic treatment for lymphoma
• Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment
• Age 18-75 years
• ECOG Performance Status of 0-2 .Stage II, III, or IV by Ann Arbor staging system.
• Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.

1. Hematological: WBC≥3.5×109/L, Platelets ≥ 75×109/L,Absolute Neutrophil Count (ANC) ≥ 1.0×109/L，Hemoglobin (Hgb) ≥ 80 g/L

2. Renal: Calculated creatinine clearance ≥ 50 mL/min

3. Hepatic: Bilirubin ≤ 1.5 × upper limit of normal (ULN), AST/ALT ≤ 2.5×ULN

• Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain
• Life expectancy ≥6 months
• Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study

Exclusion Criteria

• Known active central nervous system lymphoma or leptomeningeal disease,
• Evidence of diffuse large B-cell transformation
• Grade 3b FL
• Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
• Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed John Cunningham (JC) virus infection，any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification. Or left ventricular ejection fraction <50%;
• Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection
• Known pneumonia associated with idiopathic pulmonary fibrosis, machine (for example, occlusive bronchiolitis), history of drug induced pneumonia, or screening during the chest computed tomography (CT) showed active pneumonia
• Have serious neurological or psychiatric history, can't normal study, including dementia, epilepsy, severe depression and mania
• Patients who were deemed by the investigator to be ineligible for enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huilai Zhang, MD,PhD

Role: CONTACT

18526812877@163.com

02223359337

Facility Contacts

Huilai Zhang, MD,PhD

Role: primary

0086-22-23359337

Other Identifiers

FL-IIT02

Identifier Type: -

Identifier Source: org_study_id