Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma (BATMAN)

A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma

The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.

Study Overview

• Status: Completed
• Conditions: Mantle Cell Lymphoma
• Intervention / Treatment: Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eunhee Park, CRN; Phone Number: 82-2-743-1453; Email: eh.park@daum.net
• Study Contact Backup: Name: Junghoon Shin, MD; Phone Number: 82-10-2015-4932; Email: freeustand@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically confirmed mantle cell lymphoma
• Relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents
• ECOG performance status 2 or less
• Adequate hematologic, hepatic, and renal function i. White blood cells ≥ 3,000 /ul ii. Absolute neutrophil count ≥ 1,000 /ul iii. Platelets ≥ 50,000 /ul iv. Hemoglobin ≥ 9.0 g/dL v. Total bilirubin < 2 times upper limit of normal vi. AST, ALT < 2.5 times upper limit of normal vii. Serum creatinine < 1.5 times upper limit of normal

Exclusion Criteria:

• Previously treated with 4 or more lines of chemotherapy with or without immunologic agents
• Previously treated with bortezomib
• Treated with a cytarabine-containing regimen as the last line and within 6 months before registration
• Other cancer diagnosed within 5 years before registration
• Uncontrolled symptomatic CNS involvement of mantle cell lymphoma
• Uncontrolled systemic infection
• Inherited immunodeficiency disease or AIDS
• Pregnancy
• Breast-feeding
• Peripheral neuropathy of grade 3 or higher
• Other health conditions considered to be inappropriate for this trial in the primary physician's opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim; Bortezomib: 1.3mg/m2 per day, SC (mixed with normal saline 1.4ml) on day 1, 4, 8, and 11 of each 28-day cycle Cytarabine: 1.5g/m2 per day, IV (in the vein) over 3 hours on day 2 and 3 of each 28-day cycle for subjects aged less than 65 and 1g/m2 with the same route and schedule for those aged 65 or older Dexamethasone: 20mg per day, IV (in the vein) or PO on day 1, 4, 8, and 11 of each 28-day cycle Pegfilgrastim: 6mg once, SC on day 13 of each 28-day cycle Number of cycles: 6 unless progression or unacceptable toxicity develops within 6 cycles; Other Names: Protezomib, Cytarabine, Dexamethasone, Neulapeg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response	Lugano classification	within 28 days after the last cycle of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response	Lugano classification	within 28 days after the last cycle of treatment
Overall survival	Interval from registration to death from any cause	5 years
Progression-free survival	Interval from registration to progression or death from any cause	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	EORTC QLQ-C30	within 28 days after the last cycle of treatment
Toxicity	NCI CTCAE version 4.03	within 28 days after the last cycle of treatment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Consortium for Improving Survival of Lymphoma
• Investigators: Principal Investigator: Youngil Koh, MD, Seoul National University Hospital

Publications and helpful links

General Publications

• Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cytarabine; Bortezomib; Mantle cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Mantle-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Bortezomib; Cytarabine
• Other Study ID Numbers: SNUH-1602-153-747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographics, baseline characteristics, response, survival data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No