NCT03241017

Brief Summary

The trial assess the progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Typical duration for phase_2

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 26, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

4 years

First QC Date

July 26, 2017

Last Update Submit

April 5, 2018

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Diffuse Large B-Cell LymphomaDouble-hit LymphomasGrey Zone LymphomasDouble or Triple Expressor LymphomasUnclassifiable Aggressive Lymphoma typesAggressive Lymphomas

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Number of Patients with Progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.

    24 months

Secondary Outcomes (5)

  • Response Rate

    24 months

  • Adverse Events

    24 months

  • Hematologic engraftment

    24 months

  • The quality of life

    24 months

  • Overall Survival

    24 months

Study Arms (1)

Durvalumab

EXPERIMENTAL

Durvalumab 1500 mg (day 1) given every 4 weeks for a total of 12 applications (1 year).

Drug: Durvalumab

Interventions

DurvalumabDRUG

Immunotherapy with Durvalumab after ASCT

Durvalumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with any types of DLBCL (de novo or transformed), including double-hit lymphomas, grey zone lymphomas, double or triple expressor lymphomas, unclassifiable aggressive lymphoma types or aggressive lymphomas.
  • Lymphoma patients (as listed above) in first remission considered as high-risk and defined as lymphoma patients not achieving a complete first remission after induction treatment before subsequent ASCT; or patients in second remission considered as high-risk and defined as lymphoma patients relapsing within 12 months after first-line treatment or lymphoma patients not achieving a complete second remission after salvage treatment before subsequent ASCT.
  • ECOG 0-2
  • Age 18-75 years
  • Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to study treatment, and they must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months.
  • Patients must have given voluntary written informed consent.

You may not qualify if:

  • Other types of malignant lymphomas
  • Previous treatment with antibodies against PD-(L)1
  • Symptomatic CNS (Central Nervous System) involvement by lymphoma
  • Active infection requiring antibiotic/antifungal treatment
  • Lack of patient cooperation to allow study treatment as outlined in this protocol
  • Pregnancy or lactating female patients
  • Major surgery less than 30 days before start of treatment
  • Contraindications and hypersensitivity to any of the active chemotherapy compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Thomas Pabst, MD

    Departement of Medical Oncology, University Hospital Berne

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Interventional, prospective, single-center, open-label, single-arm, non-comparative and non-randomized phase II study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 7, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

April 9, 2018

Record last verified: 2018-04