Obinutuzumab Combined With Lenalidomide(GL) in Recurrent or Refractory Marginal Zone Lymphoma (MZL)

• Status: Recruiting
• Trial end date: 2028-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multi-center clinical study to enroll 59 patients with relapsed and refractory MZL. The study was designed to assess the efficacy and safety of the combination of obintuzumab and lenalidomide in the treatment of relapsed and refractory(R/R) marginal zone lymphoma (MZL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Lenalidomide; Obinutuzumab

Criteria

Inclusion Criteria:

1. The patient voluntarily agreed to participate in the study, signed the informed consent form and complied with the study protocol

2. Age ≥18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

4. Histologically confirmed MZL. For splenic marginal zone lymphoma (SMZL) for which histological specimens of the spleen are not available, it is required to meet the minimum diagnostic criteria for SMZL and exclude any other type of small B-cell lymphoma, that is, it is required to have a definite diagnosis of MZL

5. Prior treatment with at least one line of systemic lymphoma including prior immunotherapy or chemoimmunotherapy

6. 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)

7. Need for systemic therapy as assessed by the investigator based on tumor size and/or GELF criteria

8. Life expectancy ≥ 3 months

9. 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

10. Normal laboratory values:

Creatinine clearance ≥ 30 mL/min measured or estimated according to institutional standard methods AST or ALT ≤ 2.5 x upper limit of normal (ULN) Serum bilirubin ≤ 2 × ULN (≤ 3 × ULN in patients with Gilbert's syndrome)

11. 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)

12. 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 -

Exclusion Criteria:

1. Patients who were refractory or resistant to lenalidomide or obinutuzumab, refractory was defined as no response (PR or CR) after the start of treatment, or relapse within 6 months (≤ 2 cycles of prior lenalidomide or obinutuzumab and no exclusion of treatment change for non-refractory reasons)

2. History of serious allergic or anaphylactic reactions to monoclonal antibody therapy

3. Known hypersensitivity to any of the study drugs

4. Known sensitivity to murine products

5. Previous ≥ Grade 3 allergic reactions/Hypersensitivity to thalidomide

6. History of erythema multiforme, Grade 3 rash, or blisters following prior immunomodulatory derivative therapy

7. Histologically transformed, highly malignant or diffuse large B-cell lymphoma

8. Central nervous system or meningeal involvement by lymphoma

9. Contraindications for the investigational medical product included in the study treatment regimen

10. Positive test for chronic hepatitis B infection (defined as positive HBsAg serology)

11. Hepatitis C positive (hepatitis C virus antibody serology)

12. HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive

13. Evidence of any serious, uncontrolled co-morbidities that could 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)

14. 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

15. Prior malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years

16. Pregnant or lactating women.

17. Have ≥ Grade 2 neuropathy

18. Participation in another clinical trial using a pharmacological intervention during the trial or within 28 days prior to Cycle 1

19. Corticosteroids within 4 weeks of enrollment, unless administered at a dose equivalent to ≤ 30 mg/day prednisone (within 4 weeks)

20. Past history of progressive multifocal leukoencephalopathy (PML)

21. Live vaccines within 28 days of treatment start

22. History of solid organ transplantation

23. Presence of any serious illness or abnormality in the clinical laboratory test results that, in the opinion of the investigator, would make the patient unable to safely participate and complete this study, or affect protocol compliance or interpretation of results

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