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

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ClinicalTrials.gov Identifier: NCT02840539
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Consortium for Improving Survival of Lymphoma
Information provided by (Responsible Party):
Youngil Koh, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Actual Study Start Date : October 11, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2025


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 Name: Protezomib, Cytarabine, Dexamethasone, Neulapeg




Primary Outcome Measures :
  1. Overall response [ Time Frame: within 28 days after the last cycle of treatment ]
    Lugano classification


Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840539


Contacts
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Contact: Eunhee Park, CRN 82-2-743-1453 eh.park@daum.net
Contact: Junghoon Shin, MD 82-10-2015-4932 freeustand@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Eunhee Park, CRN    82-2-743-1453    eh.park@daum.net   
Sub-Investigator: Junghoon Shin, MD         
Sponsors and Collaborators
Seoul National University Hospital
Consortium for Improving Survival of Lymphoma
Investigators
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Principal Investigator: Youngil Koh, MD Seoul National University Hospital

Publications:
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Responsible Party: Youngil Koh, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02840539     History of Changes
Other Study ID Numbers: SNUH-1602-153-747
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Demographics, baseline characteristics, response, survival data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Youngil Koh, Seoul National University Hospital:
Mantle cell lymphoma
Bortezomib
Cytarabine

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone
Dexamethasone acetate
Bortezomib
Cytarabine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites