NCT03392714

Brief Summary

This pilot study will i) evaluate the efficacy and the safety of bendamustine-based combination chemotherapy and ii) investigate the pharmacokinetics (PK)of bendamustine in plasma and CSF when given as salvage treatment for patients with relapsed or refractory primary central nervous system lymphoma (PCNSL).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

December 6, 2017

Last Update Submit

January 2, 2018

Conditions

PCNSL

Keywords

BendamustineCSFPharmacokineticsPCNSLSalvage therapy

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    rate of complete or partial response (CR/PR)

    2 year

Secondary Outcomes (5)

  • Toxicity based on NCI Common Terminology Criteria version 4.0

    2 year

  • Progression-free survival (PFS)

    2 years

  • Overall survival (OS)

    2 years

  • Maximum concentration [Cmax] of bendamustine in plasma and CSF

    6 months

  • Area under the curve [AUC] of bendamustine in plasma and CSF

    6 months

Study Arms (1)

R-B(O)AD

EXPERIMENTAL

Intravenous R-B(O)AD every 4 weeks for up to 4 cycles

Drug: R-B(O)AD

Interventions

R-B(O)ADDRUG

rituximab 375 mg/m2 on day 1; vincristine 1.4 mg/m2 on day 1, omitted in patients ≥70 years of age due to risk of neurotoxicity; bendamustine 75 mg/m2 over 1 h on days 2 and 3; cytarabine 1000 mg/m2 over 3 h on days 2-4; dexamethasone 20 mg on days 1-4, administered intravenously

R-B(O)AD

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PCNSL of diffuse large B-cell lymphoma (DLBCL) with a CNS lesion by tissue biopsy
  • Age ≥ 19 years old
  • Relapsed or refractory PCNSL after frontline combined chemotherapy or radiation
  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1000/uL
  • Platelets ≥ 100,000/uL
  • Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
  • Aspartate aminotransferase (AST) ≤ 3 x ULN
  • Creatinine ≤ 2.0 x ULN

You may not qualify if:

  • PCNSL of other than DLBCL or T-cell lymphoma with a CNS lesion by tissue biopsy
  • Any of the following: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
  • Uncontrolled infection
  • Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration
  • Persistent toxicities ≥ grade 3 from prior chemotherapy or biologic therapy regardless of interval since last treatment
  • History of thromboembolic episodes ≤ 3 months prior to registration
  • Active hepatitis B or C with uncontrolled disease
  • Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
  • Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
  • Major surgery ≤ 4 weeks prior to registration or have not recovered from side effects of such therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 519-809, South Korea

Location

Related Publications (1)

  • Kim T, Choi HY, Lee HS, Jung SH, Ahn JS, Kim HJ, Lee JJ, Yoo HD, Yang DH. Clinical response and pharmacokinetics of bendamustine as a component of salvage R-B(O)AD therapy for the treatment of primary central nervous system lymphoma (PCNSL). BMC Cancer. 2018 Jul 9;18(1):729. doi: 10.1186/s12885-018-4632-y.

    PMID: 29986691DERIVED

Study Officials

  • Deok-Hwan Yang, MD

    Chonnam National University Hwasun Hospital, Department of Hematology-Oncology

    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
Principal Investigator

Study Record Dates

First Submitted

December 6, 2017

First Posted

January 8, 2018

Study Start

January 20, 2016

Primary Completion

January 20, 2018

Study Completion

January 20, 2019

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)