Rituximab and Pegylated Interferon α-2b in Patients With Indolent B-cell Lymphoma

NCT04246359 | Unknown Phase 2

• 1 other identifier: RIPPLE
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 2 open label study to evaluate safety and activity of Rituximab(HLX01) in combination with Pegylated interferon α-2b in patients with newly diagnosed advanced indolent B-cell lymphoma.

Conditions

Lymphoma, B-Cell

Keywords

indolent B-cell lymphoma; Rituximab(HLX01); Pegylated Interferon α-2b; HBsAg clearance rate

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)、Complete Remission Rate (CRR)、Partial Remission Rate (PRR)

  Short-term effcacy according to Lugano 2014 Malignant Lymphoma Evaluation Criteria

  Up to 21 weeks

• HBsAg clearance rate and anti-Hbs antibody positive rate in patients with chronic hepatitis B at 72 weeks

  Evaluate HBsAg clearance rate and positive rate of anti-Hbs antibody

  Up to 72 weeks

Secondary Outcomes (5)

• Progression Free Survival (PFS) time,

  Up to 3 years

• Duration of Response (DOR)

  Up to 3 years

• Overall survival(OS)

  Up to 5 years

• Frequency and severity of adverse events (AE), frequency of Serious Adverse Event (SAE)

  Up to 2 years

• Ratio of Physical Function and Fatigue Improvement by EORTC Quality of Life Scale QLQ-C30 (V3.0) (on the first day of each course and at each follow-up, up to 60 months)

  Up to 2 years

Study Arms (1)

RP induction and maintenance

EXPERIMENTAL

1\. Induction phase: 1. Rituximab: 375mg / m2, ivd, d1; 2. Pegylated interferon α-2b: 135 μg (500,000 U), H, d1, 8 Repeated every 21 days, Maximum 6 cycles 2. Maintenance phase: 1\) Rituximab: 375mg / m2, ivd, d1; 2) Pegylated interferon α-2b: 135 μg (500,000 U), H, d1,30 Repeated every 2 months, Maximum 12 cycles

Drug: Rituximab Biosimilar; Drug: Pegylated Interferon α-2b

Interventions

Rituximab Biosimilar DRUG

To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.

Also known as: HLX01

RP induction and maintenance

Pegylated Interferon α-2b DRUG

To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.

RP induction and maintenance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age, male or female;
• Patients with a diagnosis of indolent B-cell non-Hodgkin's lymphoma (iNHL),including following subtypes：follicular lymphoma (grade Ⅰ, Ⅱ), intra-nodal and extra-mucosa-associated lymph Tissue marginal zone lymphoma (MALT), spleen marginal zone B-cell lymphoma, lymph node marginal zone lymphoma(MZL), Lymphocele lymphoma (except macroglobulinemia), small lymphocytic lymphoma(SLL);
• Treatment naive, and Lugano stage III-IV;
• Life expectancy at least 12 months;
• At least one evaluable or measurable disease that meets the Lugano 2014 criteria for malignant lymphoma \[Evaluable lesions: 18 fluorodeoxyglucose-positron emission tomography (18FDG/PET) examination showed increased local uptake of lymph nodes or extranodal nodes (higher than liver) and PET and /or Computed Tomography (CT) features consistent with lymphoma features; Measurable lesions: nodular lesions\> 15mm in diameter or extranodal lesions\> 10mm (if only one measurable lesion has previously received radiotherapy, evidence of radiographic progression after radiotherapy is required), and accompanied by 18FDG increased intake\]. It is necessary to exclude cases where there is no measurable lesion and diffuse liver 18FDG uptake is increased;
• ECOG score 0-2;
• Organs and bone marrow function normally (within 14 days prior to study drug use, without receiving blood transfusion, granulocyte colony-stimulating factors or other related medical support):
• Absolute value of neutrophils ≥1.0 × 109 / L;
• Platelets ≥50 × 109 / L;
• Hemoglobin ≥8 g / dL;
• Serum creatinine ≤ 1.5 times Upper Limit Normal (ULN), or creatinine removal rate ≥40mL / min (estimated according to Cockcroft-Gault formula);
• serum total bilirubin ≤ 1.5 times ULN;
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤ 2.5 times ULN;
• Coagulation function: International Normalized Ratio (INR)≤1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5 times ULN (unless the patient is receiving anticoagulant therapy and PT and APTT are within the expected range at the time of screening);
• Female patients of childbearing age must have a negative pregnancy test at the time of enrollment and are willing to use reliable contraceptive methods, i.e. barrier methods, oral contraceptives, implant methods, skin contraception, long-acting injection contraceptives, intrauterine devices, or tubal ligation;

You may not qualify if:

• Primary CNS lymphoma or secondary CNS involvement;
• A history of severe allergic reactions to humanized or murine monoclonal antibodies;
• Patients have active autoimmune disease that requires systemic treatment in the past two years. (hormonal replacement therapy is not considered as a systemic treatment, such as patients with type 1 diabetes, adrenal function due to hypothyroidism that only requires thyroxine replacement therapy, low or pituitary dysfunction which only requires physiological doses of glucocorticoid replacement therapy); Patients with autoimmune disease without systemic treatment in the past two years can be enrolled;
• Patients who require systemic glucocorticoid therapy or other immunosuppressive therapy within 14 days before study 【patients are permitted to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (with very low systemic absorption), to receive short-term (≤ 7 days) preventive treatment with glucocorticoids (such as contrast agent hypersensitivity) or treatment of non-autoimmune diseases (such as delayed onset of hypersensitivity caused by contact allergen】.Low-dose hormone debulking treatment due to large tumor burden is allowed (prednisone 20mg × 7 days or equivalent dose of other hormones are allowed);
• Have other malignancies in the past 5 years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix after radical treatment;
• Within 28 days before study treatment, patients receiving systemic anti-tumor treatments, including chemotherapy, immunotherapy, biotherapy (tumor vaccine, cytokine, or growth factor that controls cancer);
• Major surgery was performed within 28 days before study treatment, or radiotherapy was performed within the first 90 days;
• Within 7 days before study treatment, patients receiving anti-cancer Chinese herbal medicine or proprietary Chinese medicine treatment;
• Live vaccines (excluding influenza attenuated vaccines) within 28 days before study treatment;
• A history of Human Immunodeficiency Virus (HIV) disease Patients with viral infection and / or acquired immunodeficiency syndrome;
• Patients with active chronic hepatitis B or active hepatitis C. Patients who are Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies positive during the screening period must have the Hepatitis B Virus (HBV) DNA titer test (must not higher than 2500 copies/mL or 1000 I /mL) and HCV RNA test (not to exceed the detection limit of the assay 10,000 copies/mL). Patients can enter the study if there is no treatment require. Patients with carriers of hepatitis B virus, stable hepatitis B after treatment (DNA titers of no more than 2500 copies / mL or 1000 IU / mL), and cured hepatitis C can be enrolled;
• Any active infection requiring systemic anti-infective treatment within 14 days study treatment;
• Female patients during pregnancy or lactation;
• Patients with a history of alcohol or drug abuse;
• Suffering from uncontrollable comorbidities, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer or bleeding disorders;

Sponsors & Collaborators

• Huiqiang Huang: lead

Study Sites (1)

Department of Medical Oncology, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

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

Study Officials

• Ye Cao, Professor

  Ethics Committee of Cancer Center of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang, Professor

CONTACT

+86 020 87343350; huanghq@sysucc.org.cn

Yan Gao, Professor

CONTACT

+86 020 87343349; gaoyan@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 29, 2020
• Study Start: January 15, 2020
• Primary Completion: June 16, 2022
• Study Completion: January 16, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

CN (1)