Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma

NCT02840539 | Completed Phase 2 DMC

• 1 other identifier: SNUH-1602-153-747
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma; Bortezomib; Cytarabine

Outcome Measures

Primary Outcomes (1)

• Overall response

  Lugano classification

  within 28 days after the last cycle of treatment

Secondary Outcomes (3)

• Complete response

  within 28 days after the last cycle of treatment

• Overall survival

  5 years

• Progression-free survival

  5 years

Other Outcomes (2)

• Quality of life

  within 28 days after the last cycle of treatment

• Toxicity

  within 28 days after the last cycle of treatment

Study Arms (1)

Experimental

EXPERIMENTAL

Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

Interventions

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

Also known as: Protezomib, Cytarabine, Dexamethasone, Neulapeg

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Consortium for Improving Survival of Lymphoma: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (2)

• 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.

  PMID: 25738670 BACKGROUND

• Shin J, Lee JY, Lee GW, Kim WS, Park Y, Do YR, Kim DS, Kim KH, Choi YS, Byun JM, Hong J, Kim I, Yoon SS, Koh Y. Phase II study of bortezomib, cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma. Br J Haematol. 2023 Sep;202(6):e54-e57. doi: 10.1111/bjh.18965. Epub 2023 Jul 5. No abstract available.

  PMID: 37408333 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Bortezomib; Cytarabine; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Youngil Koh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: October 11, 2016
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)