A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma

Last updated: August 3, 2024
Sponsor: Kim, Seok Jin
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoproliferative Disorders

Mantle Cell Lymphoma

Treatment

RB/RBAC alternating

RB

Clinical Study ID

NCT05245656
2021-11-126
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. newly diagnosed, previously untreated, histologically confirmed CD20+ mantle celllymphoma, confirmed by WHO classification criteria

  2. age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapywith autologous stem cell transplantation.

  3. ECOG performance status 2 or less

  4. 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 basedon the Cockcroft-Gault method

  • adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times theupper 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 ifthe 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 theywere related to bone marrow involvement)

  1. Written informed consent

Exclusion

Exclusion Criteria:

  1. In-situ mantle cell lymphoma

  2. Ann Arbor stage 1 disease

  3. Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5years.

  4. Active malignancy within the past 3 years except for localized non-melanoma skincancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ,or localized prostate cancer that has been definitely treated,

  5. Central nervous system involvement

  6. HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriateprophylactic antiviral therapy using entecavir, tenofovir, and so on)

  7. History of prior hepatitis C infection (patients positive for HCV IgG will beeligible if they are negative for HCV-RNA)

  8. Known history of human immunodeficiency virus (HIV) infection

  9. any serious illness or medical conditions that are unstable or could jeopardize thesafety 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 includingdementia and seizure disorder

  • Severe chronic obstructive pulmonary disease with hypoxemia

  • Cerebrovascular disease including transient ischemic attack within the past 6months

  • Non-healing wound, ulcer, or bone fracture

  • Active uncontrolled bacterial, viral, or fungal infection requiring systemictherapy

  1. concomitant administration of any other experimental drugs under investigation

  2. Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol

  3. major surgical procedure or significant trauma within 28 days before start of studytreatment, open biopsy within 7 days before start of study treatment

  4. If the patient's partner is a woman who could possibly get pregnant, men who didn'thave a vasectomy must agree to use medically recommended methods for adequatecontraception (tubal ligation, intrauterine devices, or barriers [diaphragm,cervical cap] in the patient's partner and the use of condoms in men) when sexuallyactive.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: RB/RBAC alternating
Phase: 2
Study Start date:
October 18, 2022
Estimated Completion Date:
December 31, 2029

Study 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).

Connect with a study center

  • Samsung Medical Center

    Seoul, Gangnam-Gu 06351
    Korea, Republic of

    Active - Recruiting

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