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

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle cell lymphoma, Bortezomib, Cytarabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

Outcomes

Primary Outcome Measures

Overall response
Lugano classification

Secondary Outcome Measures

Complete response
Lugano classification
Overall survival
Interval from registration to death from any cause
Progression-free survival
Interval from registration to progression or death from any cause

Full Information

First Posted
July 19, 2016
Last Updated
March 16, 2023
Sponsor
Seoul National University Hospital
Collaborators
Consortium for Improving Survival of Lymphoma
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1. Study Identification

Unique Protocol Identification Number
NCT02840539
Brief Title
Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma
Acronym
BATMAN
Official Title
A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2016 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Consortium for Improving Survival of Lymphoma

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Mantle cell lymphoma, Bortezomib, Cytarabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Intervention Type
Drug
Intervention Name(s)
Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Other Intervention Name(s)
Protezomib, Cytarabine, Dexamethasone, Neulapeg
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall response
Description
Lugano classification
Time Frame
within 28 days after the last cycle of treatment
Secondary Outcome Measure Information:
Title
Complete response
Description
Lugano classification
Time Frame
within 28 days after the last cycle of treatment
Title
Overall survival
Description
Interval from registration to death from any cause
Time Frame
5 years
Title
Progression-free survival
Description
Interval from registration to progression or death from any cause
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
EORTC QLQ-C30
Time Frame
within 28 days after the last cycle of treatment
Title
Toxicity
Description
NCI CTCAE version 4.03
Time Frame
within 28 days after the last cycle of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngil Koh, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Demographics, baseline characteristics, response, survival data
Citations:
PubMed Identifier
25738670
Citation
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.
Results Reference
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Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma

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