A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
Primary Purpose
Mantle Cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RB/RBAC alternating
RB
Sponsored by
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma
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
- 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.
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RB/RBAC alternating
RB
Arm Description
Every 4 weeks for 6 cycles RB (1st, 3rd, and 5th cycles) Rituximab + Bendamustine RBAC (2nd, 4th, and 6th cycles) Rituximab + Bendamustine + Cytarabine
Every 4 weeks for 6 cycles - Rituximab + Bendamustine
Outcomes
Primary Outcome Measures
Progression-freesurvival
Secondary Outcome Measures
Overall Survival
Duration of Response
Event Free Survival
Overall response rate
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05245656
Brief Title
A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kim, Seok Jin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RB/RBAC alternating
Arm Type
Experimental
Arm Description
Every 4 weeks for 6 cycles
RB (1st, 3rd, and 5th cycles)
Rituximab + Bendamustine
RBAC (2nd, 4th, and 6th cycles)
Rituximab + Bendamustine + Cytarabine
Arm Title
RB
Arm Type
Active Comparator
Arm Description
Every 4 weeks for 6 cycles
- Rituximab + Bendamustine
Intervention Type
Drug
Intervention Name(s)
RB/RBAC alternating
Intervention Description
Patients assigned to the RB alternating with RBAC arm will receive six cycles of alternating RB (odd cycles) or RBAC (even cycles)
RB (1st, 3rd, and 5th cycles)
Rituximab 375mg/m2, IV, D1
Bendamustine 90mg/m2, IV, D1-2
RBAC (2nd, 4th, and 6th cycles)
Rituximab 375mg/m2, IV, D1
Bendamustine 70mg/m2, IV, D2-3
Cytarabine 500mg/m2, IV, D2-4
Intervention Type
Drug
Intervention Name(s)
RB
Intervention Description
Every 4 weeks for 6 cycles
Rituximab 375mg/m2, IV, D1
Bendamustine 90mg/m2, IV, D1-2
Primary Outcome Measure Information:
Title
Progression-freesurvival
Time Frame
Up to 84 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Up to 84 months
Title
Duration of Response
Time Frame
Up to 84 months
Title
Event Free Survival
Time Frame
Up to 84 months
Title
Overall response rate
Time Frame
Up to 84 months
Title
Adverse events
Time Frame
From the day 1 of the clinical trial to 28 days after last drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kim seok jin, phD
Phone
82-10-9933-1766
Email
hjds.shin@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
shin hyunjung
Phone
82-2-3410-6763
Email
hjds.shin@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok Jin Kim, Ph.D
Phone
82-2-3410-1766
Email
seokjin88.kim@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
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