Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma

NCT05846750 | Recruiting Phase 2 DMC

• 1 other identifier: BDHMZL2023
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter clinical study that will enroll 59 patients with relapsed and refractory (R/R) MZL. The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma (MZL).

Conditions

Marginal Zone Lymphoma

Keywords

Obinutuzumab; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Overall Remission Rate(ORR)

  Disease response evaluation after 6 cycles will be used to determine the overall remission rate

  24 weeks

Secondary Outcomes (4)

• 2-year Progression Free Survival (PFS24):

  up to 4.5 years

• 2-year Event-Free Survival (EFS24)

  up to 4.5 years

• Complete Response Rate (CR)

  24 weeks

• Overall survival (OS)

  up to 4.5 years

Study Arms (1)

Obinutuzumab and lenalidomide

EXPERIMENTAL

Patients will be treated with obinutuzumab and lenalidomide for 6 cycles as induction, and the patients who achieve at least a partial response after 6 cycles of induction therapy will be eligible to enter the maintenance phase for 2 years

Drug: Obinutuzumab; Drug: lenalidomide

Interventions

Obinutuzumab DRUG

Induction (6 cycles, every 28 days/cycle): 1000 mg each time, administered on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 ( 8 total infusions)； Maintenance(12 cycles, every 2 months/cycle): 12 infusions of 1000 mg every 2 months for 2 years or until disease progression

Also known as: GA101

Obinutuzumab and lenalidomide

lenalidomide DRUG

Induction( 6 cycles, every 28 days/cycle): 20 mg/day, oral, Dosing on Days 2-22, every 28 days/cycle of Cycles 1-6； Maintenance(12 cycles, every 28 days/cycle):10 mg on Days 2-22 of each 28-day cycle, 12 cycles for 1 year or until disease progression

Obinutuzumab and lenalidomide

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Histologically confirmed MZL. have a definite diagnosis of MZL
• Prior treatment with at least one line of systemic lymphoma including prior immunotherapy or chemoimmunotherapy
• At least one bi-dimensionally measurable nodal lesion (\> 1.5 cm in greatest diameter on CT scan or MRI) OR at least one bi-dimensionally measurable extranodal lesion (\> 1.0 cm in greatest diameter on CT scan or MRI)
• Need for systemic therapy as assessed by the investigator
• Life expectancy ≥ 3 months
• Adequate blood function (except for abnormalities considered by the investigator to be due to the underlying disease of lymphoma), defined as follows:
• Hemoglobin ≥ 7 g/dL; Absolute neutrophil count ≥ 1.0 × 109/L; Platelet count ≥ 50 x 109/L
• Normal laboratory values:
• Creatinine clearance ≥ 30 mL/min; Glutathione transaminase(AST) or glutathione aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Serum bilirubin ≤ 2 × ULN (≤ 3 × ULN in patients with Gilbert's syndrome)
• For men who are not surgically sterile: Agree to use barrier contraception during treatment and for at least 3 months after the last dose of obinutuzumab or lenalidomide or as required by institutional guidelines, whichever is longer. In addition, male patients must agree to have their partner use an alternative method of contraception (e.g., oral contraceptive, intrauterine device, barrier method, or spermicide)
• For women who are not surgically sterile: use two appropriate methods of contraception, such as oral contraceptives, intrauterine device, or barrier methods, in combination with spermicide for at least 28 days prior to agreeing to start of study medication, during treatment and for at least 12 months after the last dose of either obinutuzumab or lenalidomide, or as required by institutional guidelines, whichever is longer -

You may not qualify if:

• History of serious allergic or anaphylactic reactions to monoclonal antibody therapy
• Known hypersensitivity to any of the study drugs
• Known sensitivity to murine products
• Previous ≥ Grade 3 allergic reactions/Hypersensitivity to thalidomide
• History of erythema multiforme, Grade 3 rash, or blisters following prior immunomodulatory derivative therapy
• Histologically transformed, highly malignant or diffuse large B-cell lymphoma
• Central nervous system or meningeal involvement by lymphoma
• Contraindications for the investigational medical product included in the study treatment regimen
• Positive test for chronic hepatitis B infection (defined as positive HBsAg serology)
• Hepatitis C positive (hepatitis C virus antibody serology)
• HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive
• Evidence of any serious, uncontrolled co-morbidities that affect compliance with the protocol or interpretation of results, including but not limited to significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina), or significant pulmonary disease (including history of obstructive pulmonary disease or bronchospasm)
• Infection caused by known active bacteria, viruses, fungi, or other microorganisms (other than fungal infection of the nail bed), or any major infection requiring intravenous antibiotics or hospitalization (completion of the entire course of antibiotics, except for neoplastic fever) within 4 weeks prior to enrollment
• Prior malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years
• Pregnant or lactating women.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tian, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

obinutuzumab; Lenalidomide

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shuhua Yi, Dr

  Institute of Hematology & Blood Diseases Hospital, Chinese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shuhua Yi, Dr

CONTACT

86-22-23909106; yishuhua@ihcams.ac.cn

Lugui Qiu, Dr

CONTACT

86-22-23909172; qiulg@ihcams.ac.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

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 19, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)