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Trial record 14 of 15 for:    "Central Nervous System Lymphoma" | "Dexamethasone"

Bendamustine-based Combination Therapy for PCNSL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03392714
Recruitment Status : Active, not recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Deok-Hwan Yang, Chonnam National University Hospital

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).

Condition or disease Intervention/treatment Phase
PCNSL Drug: R-B(O)AD Phase 2

Detailed Description:
A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. Based on the demonstrated activity and proposed additive mechanisms of the chemotherapeutic agents included in the bendamustine-based combination regimen, the efficacy and safety of R-B(O)AD will be evaluated for treatment of relapsed/refractory (R/R) primary CNS lymphoma. Evidence from previous preclinical tissue distribution studies and single agent intravenous drug therapy trials in CNS malignancies suggests that bendamustine penetrates brain and tumor tissue, however there are no clinical data available on the PK of bendamustine in the CSF. This study will evaluate the PK of plasma and CSF drug levels through a population based nonlinear mixed-effects model approach in a R/R PCNSL cohort with the goals to define the currently unknown PK profile of bendamustine in the CSF and to further characterize the relationship between plasma and CSF drug levels, and the influence of exposure on response to therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasma and Cerebrospinal Fluid (CSF) Pharmacokinetics of Bendamustine as a Component of Salvage Therapy for Primary Central Nervous System Lymphoma (PCNSL)
Actual Study Start Date : January 20, 2016
Estimated Primary Completion Date : January 20, 2018
Estimated Study Completion Date : January 20, 2019


Arm Intervention/treatment
Experimental: R-B(O)AD
Intravenous R-B(O)AD every 4 weeks for up to 4 cycles
Drug: R-B(O)AD
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




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 2 year ]
    rate of complete or partial response (CR/PR)


Secondary Outcome Measures :
  1. Toxicity based on NCI Common Terminology Criteria version 4.0 [ Time Frame: 2 year ]
    adverse event incidence of combination regimen

  2. Progression-free survival (PFS) [ Time Frame: 2 years ]
    calculated from the time of study entry until progression, relapse, or death

  3. Overall survival (OS) [ Time Frame: 2 years ]
    calculated from the time of study entry until death

  4. Maximum concentration [Cmax] of bendamustine in plasma and CSF [ Time Frame: 6 months ]
    peak concentration of bendamustine after 1 hour IV infusion

  5. Area under the curve [AUC] of bendamustine in plasma and CSF [ Time Frame: 6 months ]
    overall exposure of bendamustine after IV infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03392714


Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
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Principal Investigator: Deok-Hwan Yang, MD Chonnam National University Hwasun Hospital, Department of Hematology-Oncology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deok-Hwan Yang, Principal Investigator, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT03392714     History of Changes
Other Study ID Numbers: CNUHH-2016-145
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Deok-Hwan Yang, Chonnam National University Hospital:
Bendamustine
CSF
Pharmacokinetics
PCNSL
Salvage therapy

Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents