Skip to main content
OpenTrials
Completed

NCT Number: NCT02840539

Trial of Bortezomib, Cytarabine, and Dexamethasone in 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

Drug

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

Primary outcomes

  1. Overall response

    Time frame: within 28 days after the last cycle of treatment

    Lugano classification

Secondary outcomes

  1. Complete response

    Time frame: within 28 days after the last cycle of treatment

    Lugano classification

  2. Overall survival

    Time frame: 5 years

    Interval from registration to death from any cause

  3. Progression-free survival

    Time frame: 5 years

    Interval from registration to progression or death from any cause

Other outcomes

  1. Quality of life

    Time frame: within 28 days after the last cycle of treatment

    EORTC QLQ-C30

  2. Toxicity

    Time frame: within 28 days after the last cycle of treatment

    NCI CTCAE version 4.03

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Consortium for Improving Survival of Lymphoma

Registry information

Official study title

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

Acronym: BATMAN

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jul 21, 2016
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.