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

Mantle Cell Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840539
• Other study ID #: SNUH-1602-153-747
• Status: Completed
• Phase: Phase 2
• Start date: October 11, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Consortium for Improving Survival of Lymphoma

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	EORTC QLQ-C30	within 28 days after the last cycle of treatment
Other	Toxicity	NCI CTCAE version 4.03	within 28 days after the last cycle of treatment
Primary	Overall response	Lugano classification	within 28 days after the last cycle of treatment
Secondary	Complete response	Lugano classification	within 28 days after the last cycle of treatment
Secondary	Overall survival	Interval from registration to death from any cause	5 years
Secondary	Progression-free survival	Interval from registration to progression or death from any cause	5 years