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

November 24, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

A Study of the Radiotherapy Followed by Tiselizumab Combined With RCHOP in the Frontline Treatment of Follicular Lymphoma Patients With Bulky Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
          • Huilai Zhang, MD,PhD
          • Phone Number: 0086-22-23359337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Radiation: radiation therapy
received radiation (dose:18～24Gy)
Drug: Tiselizumab
200 mg iv day 1
Drug: Rituximab
375 mg/m2 intravenous [IV] day 2
Drug: Cyclophosphamide
750 mg/m2 IV day 3
Drug: Doxorubicin
50 mg/m2 IV day 3
Drug: Vincristine
1.4 mg/m2 [maximum 2.0 mg total] IV day 3
Drug: Prednisone
100 mg oral days 3-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Complete response (CR) rate
Time Frame: Through completion of treatment (estimated to be 2.5 year)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response rate (ORR)
Time Frame: Through completion of treatment (estimated to be 2.5 year)
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Through completion of treatment (estimated to be 2.5 year)
2 year progression-free survival
Time Frame: 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
The date of enrollment until disease progression or death from any cause.
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
Time Frame: Up to 30 days after completion of study treatment
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Up to 30 days after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL-IIT02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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