NCT03939234

Brief Summary

This study is investigating the efficacy of PD-L1 and PD-L2 peptides in untreated CLL patients with unmutated IGHV gene status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

April 26, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

May 3, 2019

Last Update Submit

February 4, 2022

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Clinical response according to IW-CLL

    Progressive disease (PD), stable disease (SD), partial response (PR), complete response (CR) calculated on basis of changes in circulating lymphocytes and lymphnode/spleen/liver size according to criteria from the international working group on CLL (IW-CLL).

    1 year

Secondary Outcomes (2)

  • Immune response by elispot

    1 year

  • Grades of adverse events (AE)

    1 year

Study Arms (1)

Vaccination

EXPERIMENTAL

Untreated CLL patients with unmutated IgHV gene with a cut of at maximum of 2 % mutations. According to guidelines from the European Research Initiative on CLL (ERIC).

Combination Product: PD-L1, PD-L2 peptides with Montanide ISA51

Interventions

PD-L1, PD-L2 peptides with Montanide ISA51COMBINATION_PRODUCT

PD-L1: 19 amino acid sequence from the PD-L1 protein; PD-L2: 21 amino acid sequence from the PD-L2 protein; The peptides are dissolved in dimethyl sulphoxide (DMSO) and mixed with Montanide.

Also known as: IO103, IO120
Vaccination

Eligibility Criteria

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

You may qualify if:

  • CLL according to national guidelines (Lymphoma.dk).
  • Unmutated IGHV gene according to ERIC recommendations.(25)
  • No prior CLL directed treatment
  • Age ≥ 18
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • No life-threatening conditions
  • Adequate bone marrow function: Neutrophils \> 1,0 x 109/l; Platelets \> 100 x 109/l
  • Adequate renal function: Glomeruli filtration rate (eGFR)/1,73 m2 \> 50 mL/min
  • Adequate liver function: Aspartate Aminotransferase \< 100 U/L
  • For fertile women: agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
  • For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.

You may not qualify if:

  • Other active malignant diseases requiring treatment.
  • Significant medical condition per investigators judgement e.g. severe Asthma or chronic obstructive lung disease (COLD), poorly regulated heart condition, insulin dependent diabetes mellitus.
  • Acute or chronic viral/bacterial infection e.g. human immunodeficiency virus (HIV), Cytomegalo virus (CMV), Epstein-barr virus (EBV), hepatitis or tuberculosis
  • Serious known allergies or earlier anaphylactic reactions.
  • Known sensibility towards Montanide ISA51
  • Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
  • Pregnant and breastfeeding women.
  • Fertile women not using secure contraception with a failure rate less than \< 1%
  • Psychiatric disorders that according to the investigator could influence compliance.
  • Treatment with other experimental drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

  • Klausen U, Grauslund JH, Jorgensen NGD, Ahmad SM, Jonassen M, Weis-Banke SE, Martinenaite E, Pedersen LB, Lisle TL, Gang AO, Enggaard L, Hansen M, Holmstrom MO, Met O, Svane IM, Niemann CU, Pedersen LM, Andersen MH. Anti-PD-L1/PD-L2 therapeutic vaccination in untreated chronic lymphocytic leukemia patients with unmutated IgHV. Front Oncol. 2022 Nov 22;12:1023015. doi: 10.3389/fonc.2022.1023015. eCollection 2022.

    PMID: 36483037DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

montanide ISA 51

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Uffe M Klausen, MD

    Herlev Hospital

    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
SPONSOR INVESTIGATOR
PI Title
Chief Phycisian

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 6, 2019

Study Start

April 26, 2019

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)