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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RB/RBAC alternating | Experimental | Every 4 weeks for 6 cycles RB (1st, 3rd, and 5th cycles)
RBAC (2nd, 4th, and 6th cycles)
|
|
| RB | Active Comparator | Every 4 weeks for 6 cycles - Rituximab + Bendamustine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RB/RBAC alternating | Drug | 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)
RBAC (2nd, 4th, and 6th cycles)
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-freesurvival | Up to 84 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Up to 84 months | |
| Duration of Response | Up to 84 months | |
| Event Free Survival |
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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
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kim seok jin, phD | Contact | 82-10-9933-1766 | hjds.shin@samsung.com | |
| shin hyunjung | Contact | 82-2-3410-6763 | hjds.shin@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-Gu | 06351 | South Korea |
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|
| RB | Drug | Every 4 weeks for 6 cycles
|
|
| Up to 84 months |
| Overall response rate | Up to 84 months |
| Adverse events | From the day 1 of the clinical trial to 28 days after last drug administration |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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