Actively Recruiting
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2023-07-19
59
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed marginal zone lymphoma (MZL)
- Prior treatment with at least one line of systemic lymphoma therapy including immunotherapy or chemoimmunotherapy
- At least one measurable nodal lesion (>1.5 cm) or extranodal lesion (>1.0 cm) on CT or MRI
- Need for systemic therapy as assessed by the investigator
- Life expectancy of at least 3 months
- Adequate blood function: hemoglobin ≥7 g/dL, absolute neutrophil count ≥1.0 × 10^9/L, platelet count ≥50 × 10^9/L
- Normal lab values: creatinine clearance ≥30 mL/min; AST or ALT ≤2.5 × upper limit of normal; serum bilirubin ≤2 × ULN (≤3 × ULN for Gilbert's syndrome)
- Men not surgically sterile must agree to use barrier contraception during treatment and for at least 3 months after last dose; female partners must use effective contraception
- Women not surgically sterile must use two effective contraception methods before, during, and up to 12 months after treatment or as required by guidelines
You will not qualify if you...
- Refractory or resistant to lenalidomide or obinutuzumab
- History of serious allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to study drugs or murine products
- Previous grade 3 or higher allergic reactions to thalidomide
- History of severe rash or blisters from prior immunomodulatory therapy
- Histologically transformed, highly malignant or diffuse large B-cell lymphoma
- Central nervous system or meningeal lymphoma involvement
- Contraindications to study treatment
- Positive for chronic hepatitis B, hepatitis C, HIV, or HTLV1 infections
- Serious uncontrolled comorbidities affecting study compliance, such as severe heart or lung disease
- Active infections requiring intravenous antibiotics or recent major infections
- Prior malignancy other than lymphoma unless disease-free for at least 5 years
- Pregnant or lactating women
- Grade 2 or higher neuropathy
- Participation in another drug clinical trial within 28 days prior to study
- Corticosteroid use above 30 mg/day prednisone equivalent within 4 weeks
- History of progressive multifocal leukoencephalopathy (PML)
- Live vaccines within 28 days before treatment
- History of solid organ transplantation
- Any serious illness or abnormal lab results that could interfere with study participation or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tian, China, 300020
Actively Recruiting
Research Team
S
shuhua Yi, Dr
CONTACT
L
Lugui Qiu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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