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

NCT02840539 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-03-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Consortium for Improving Survival of Lymphoma

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Youngil Koh, MD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-11
Primary Completion
2021-03-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840539 on ClinicalTrials.gov