Status:
RECRUITING
A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
Lead Sponsor:
Kim, Seok Jin
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, multicenter, open-label, active-controlled randomized trial to determine efficacy and safety of rituximab/bendamustine (RB) alternating with rituximab/bendamustine/cytarabine (RBAC)...
Detailed Description
Eligible patients will be randomly assigned to either the investigational treatment arm (RB alternating with RBAC) or the standard treatment arm (RB) in a 1:1 ratio. Patients will be stratified by age...
Eligibility Criteria
Inclusion
- newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria
- age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation.
- ECOG performance status 2 or less
- Adequate organ functions
- adequate heart function: LVEF ≥50% by echocardiography or MUGA
- adequate renal function: serum creatinine ≤ 2.0mg/dL or CrCl ≥40 mL/min based on the Cockcroft-Gault method
- adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times the upper limit of ALT if the elevation is attributed by underlying lymphoma) and ≤2 times the upper limit of ALT (≤3 times the upper limit of total bilirubin if the elevation is attributed by underlying lymphoma)
- adequate hematologic function: absolute neutrophil counts (ANC) ≥ 1,500/mL, platelet counts ≥ 100,000/mL (any ANC and platelet counts are allowed, if they were related to bone marrow involvement)
- Written informed consent
Exclusion
- In-situ mantle cell lymphoma
- Ann Arbor stage 1 disease
- Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years.
- Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,
- Central nervous system involvement
- HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)
- History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)
- Known history of human immunodeficiency virus (HIV) infection
- any serious illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
- Congestive heart failure ≥ NYHA class 3
- Acute coronary syndrome within 6 months (unstable angina or new-onset angina, myocardial infarct, or ventricular arrhythmia)
- History of significant neurological or psychological disorder including dementia and seizure disorder
- Severe chronic obstructive pulmonary disease with hypoxemia
- Cerebrovascular disease including transient ischemic attack within the past 6 months
- Non-healing wound, ulcer, or bone fracture
- Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- concomitant administration of any other experimental drugs under investigation
- Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol
- major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment
- If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers \[diaphragm, cervical cap\] in the patient's partner and the use of condoms in men) when sexually active.
Key Trial Info
Start Date :
October 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05245656
Start Date
October 18 2022
End Date
December 31 2029
Last Update
August 6 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, Gangnam-Gu, South Korea, 06351