A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

NCT03670901 | Terminated Phase 3

• 1 other identifier: JHL-CLIN-1101-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 500 subjects will be enrolled in this study. Subjects who meet the inclusion criteria will be randomized (1:1) into two groups. The study group will receive JHL1101 in combination with CHOP regimen, and the control group will receive rituximab (MabThera) in combination with CHOP. The dose of 375 mg/m2 is given intravenously on Day 1 (D1) of each cycle, and CHOP regimen is administered after the infusion of JHL1101 or rituximab is completed. Efficacy evaluation will be performed at baseline, after 3 cycles treatment (D18± 2 of Cycle 3, before the next cycle of treatment) and after 6 cycles treatment (D21±3 of Cycle 6). Subjects evaluated as progressive disease (PD) should be withdrawn from the study treatment and their subsequent treatments will be determined by the investigator. The analysis of primary endpoint is the ORR over the 6-cycle treatment period.

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  To compare the overall response rate after 6 cycles treatment

  18 weeks

Study Arms (2)

JHL1101

EXPERIMENTAL

375 mg/m2 of JHL1101 is given intravenously on D1 of each cycle

Biological: JHL1101

MabThera

ACTIVE COMPARATOR

375 mg/m2 of Rituximab is given intravenously on D1 of each cycle

Biological: MabThera

Interventions

JHL1101 BIOLOGICAL

JHL1101, 100mg/10mL

JHL1101

MabThera BIOLOGICAL

Rituximab, 100mg/10mL

MabThera

Eligibility Criteria

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

You may qualify if:

• Previously untreated patients histopathologically or cytologically diagnosed with CD20-positive DLBCL;
• Aged ≥ 18 years and and ≤ 70 years of any gender;
• International Prognostic Index (IPI) for Lymphoma score of 0 - 2 points;
• Informed consent form has been signed before any specific study procedure is performed;
• At least one measurable lesion. Intranoal lesions are defined as: the long diameter is ≥ 1.5 cm and the short diameter is ≥ 1.0 cm; for extranodal lesions, the long diameter should be ≥ 1.0 cm;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 2;
• The left ventricular ejection fraction (LVEF) measured by echocardiography is ≥ 50%;
• The patients have sufficient organ function, including:
• Absolute neutrophil count ≥ 15,000/ul; hemoglobin ≥ 80 g/L, platelet counts ≥ 75,000/uL;
• Total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN;
• Serum creatinine level ≤ 1.5 × ULN;
• Prothrombin time (PT) or activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≤ 1.5 × ULN in the absence of anticoagulant therapy;
• Men and women of childbearing age who have not undergone sterilization surgery must agree to practice effective contraception during the treatment period and within 12 months after the last administration of the study drug;
• Have an expected survival of at least 6 months as judged by the investigator.

You may not qualify if:

• Participated in other interventional clinical trials within three months prior to enrollment. Patients participating in non-interventional trials are eligible to participate in this study;
• Have received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colonystimulating factor (GM-CSF) for treatment within 14 days before enrollment;
• Patients who are or plan to be immunized with live virus vaccine within 28 days (or within 5 half-lives of the drug) before enrollment;
• Patients who underwent or plan to undergo major surgery within 28 days before enrollment, or patients whose surgical wounds have not healed;
• Patients who are receiving continuous corticosteroid treatment, with \> 30 mg/day prednisone or equivalent dose of corticosteroids for ≥ 10 days of continuous treatment;
• Have a history of gastrointestinal perforation and/or fistula within 6 months before enrollment;
• Known to be allergic to monoclonal antibody (mAb) therapy or rituximab,or patients with known sensitivity or allergy to murine products;
• Patients who have contraindications to any component of the CHOP regimen;
• Have previously received treatment for DLBCL, including:
• chemotherapy, immunotherapy, local radiotherapy for lymphoma, surgical treatment (except for tumor or pathologic biopsy and surgical resection not for lymphoma), and any monoclonal antibody therapy within 3 months prior to enrollment;
• Have previously received cytotoxic drugs or anti-CD20 monoclonal antibody therapy for other diseases (such as rheumatoid arthritis);
• Have a history of other malignancies that may affect study protocol compliance or result analysis;
• Also suffering from severe non-malignant diseases that can affect study protocol compliance, such as severe cardiovascular diseases, uncontrolled diabetes and hypertension, peripheral nervous system or central nervous system diseases;
• Known to have uncontrollable active infectious diseases or any major infection events (other than neoplastic fever) requiring intravenous antibiotic treatment or hospitalization within four weeks prior to enrollment;
• Subjects known to be positive for human immunodeficiency virus (HIV) antibody;

Sponsors & Collaborators

• JHL Biotech, Inc.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; 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)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jun Zhu, MD/PhD

  Beijing Cancer Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: November 13, 2018
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)