A Randomized Phase II Trial Comparing Rituximab/Bendamustine(RB) Alternating With Rituximab/Bendamustine/Cytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- RB/RBAC alternating
- Conditions
- Mantle Cell Lymphoma
- Sponsor
- Kim, Seok Jin
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Progression-freesurvival
- Status
- Recruiting
- Last Updated
- last year
Overview
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) compared with standard RB alone in the first-line treatment of elderly patients with mantle cell lymphoma, who are not eligible for high-dose therapy followed by autologous stem cell transplantation.
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 (≥70 years vs. 60-69), histologic morphology (blastoid/pleomorphic vs. non-blastoid/non-pleomorphic), and MIPI-C risk score (0/1 vs. 2/3).
Investigators
Kim, Seok Jin
Principal Investigator
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
RB/RBAC alternating
Every 4 weeks for 6 cycles RB (1st, 3rd, and 5th cycles) * Rituximab + Bendamustine RBAC (2nd, 4th, and 6th cycles) * Rituximab + Bendamustine + Cytarabine
Intervention: RB/RBAC alternating
RB
Every 4 weeks for 6 cycles - Rituximab + Bendamustine
Intervention: RB
Outcomes
Primary Outcomes
Progression-freesurvival
Time Frame: Up to 84 months
Secondary Outcomes
- Event Free Survival(Up to 84 months)
- Adverse events(From the day 1 of the clinical trial to 28 days after last drug administration)
- Overall response rate(Up to 84 months)
- Overall Survival(Up to 84 months)
- Duration of Response(Up to 84 months)