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

NCT06704555 | Recruiting Phase 2

• 1 other identifier: FL-IIT02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

FL; Tiselizumab

Outcome Measures

Primary Outcomes (1)

• Best Complete response (CR) rate

  Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

  Through completion of treatment (estimated to be 2.5 year)

Secondary Outcomes (3)

• Best overall response rate (ORR)

  Through completion of treatment (estimated to be 2.5 year)

• 2 year progression-free survival

  From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Percentage of Participants With Adverse Events

  Up to 30 days after completion of study treatment

Study Arms (1)

Experimental: Treatment arm

EXPERIMENTAL

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.

Radiation: radiation therapy; Drug: Tiselizumab; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

radiation therapy RADIATION

received radiation (dose:18～24Gy)

Experimental: Treatment arm

Tiselizumab DRUG

200 mg iv day 1

Experimental: Treatment arm

Rituximab DRUG

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

Experimental: Treatment arm

Cyclophosphamide DRUG

750 mg/m2 IV day 3

Experimental: Treatment arm

Doxorubicin DRUG

50 mg/m2 IV day 3

Experimental: Treatment arm

Vincristine DRUG

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

Experimental: Treatment arm

Prednisone DRUG

100 mg oral days 3-7

Experimental: Treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hematological: WBC≥3.5×109/L, Platelets ≥ 75×109/L,Absolute Neutrophil Count (ANC) ≥ 1.0×109/L，Hemoglobin (Hgb) ≥ 80 g/L
• Renal: Calculated creatinine clearance ≥ 50 mL/min
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Radiotherapy; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Huilai Zhang, MD,PhD

CONTACT

02223359337; 18526812877@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 26, 2024
• Study Start: December 20, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 26, 2024

Record last verified: 2024-10

Locations

CN (1)