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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05206357




Registration number
NCT05206357
Ethics application status
Date submitted
21/01/2022
Date registered
25/01/2022
Date last updated
4/06/2024

Titles & IDs
Public title
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
Scientific title
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms
Secondary ID [1] 0 0
2021-004555-16
Secondary ID [2] 0 0
M20-429
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab

Experimental: Epcoritamab - Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.


Treatment: Drugs: Epcoritamab
Subcutaneous Injection (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AE)
Timepoint [1] 0 0
Up to Approximately 3 Years
Primary outcome [2] 0 0
Maximum Observed Concentration (Cmax)
Timepoint [2] 0 0
Up to Approximately Week 37
Primary outcome [3] 0 0
Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)
Timepoint [3] 0 0
Up to Approximately Week 37
Secondary outcome [1] 0 0
Percentage of Participants who Achieve Complete Response (CR)
Timepoint [1] 0 0
Up to Approximately 1 Year
Secondary outcome [2] 0 0
Number of Participants with Event-free survival (EFS)
Timepoint [2] 0 0
Up to Approximately 3 Years
Secondary outcome [3] 0 0
Number of Participants who Achieve Overall Survival (OS)
Timepoint [3] 0 0
Up to Approximately 3 Years
Secondary outcome [4] 0 0
Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Timepoint [4] 0 0
Up to Approximately 1 Year
Secondary outcome [5] 0 0
Percentage of Participants Achieving Overall Response (OR)
Timepoint [5] 0 0
Up to Approximately 1 Year
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
Up to Approximately 1 Year
Secondary outcome [7] 0 0
Duration of CR (DOCR)
Timepoint [7] 0 0
Up to Approximately 1 Year
Secondary outcome [8] 0 0
Percentage of Participants Achieving Immunogenicity
Timepoint [8] 0 0
Up to Approximately Week 37

Eligibility
Key inclusion criteria
- Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or
Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other
aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with
Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.

- Disease pathologically confirmed (tumor tissue) by local testing.

- Relapsed or primary refractory disease meeting any of the following criteria:

- Progressive disease at any time during second-line chemoimmunotherapy (CIT).

- Best response of stable disease (SD) after a minimum of 2 cycles of second-line
CIT.

- Best response of partial response (PR) after a minimum of 3 cycles of second-line
CIT.

- Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but
unfit or ineligible for consolidation with cell therapy.

- Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line
CIT.

- Have received cell therapy (allogeneic or autologous transplant or chimeric
antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained
or maintained a CR.

- Recovery from toxic effects of prior chemoimmunotherapy.

- Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years
old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2
.

- Adequate bone marrow, hepatic, and renal function.
Minimum age
1 Year
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known central nervous system (CNS) involvement by lymphoma at screening as confirmed
by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron
emission tomography (PET) brain scans (participants with evidence of CNS disease only
in the cerebrospinal fluid (CSF) will be eligible).

- Other malignancy requiring therapy.

- Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal
therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other
investigational agents.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/11/2028
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital /ID# 240384 - Parkville
Recruitment hospital [2] 0 0
Perth Children's Hospital /ID# 240382 - Nedlands
Recruitment hospital [3] 0 0
Children's Hospital at Westmead /ID# 240091 - Westmead
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Vlaams-Brabant
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Prague
Country [14] 0 0
France
State/province [14] 0 0
Gironde
Country [15] 0 0
France
State/province [15] 0 0
Pays-de-la-Loire
Country [16] 0 0
France
State/province [16] 0 0
Val-de-Marne
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein-Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Marburg
Country [21] 0 0
Israel
State/province [21] 0 0
H_efa
Country [22] 0 0
Israel
State/province [22] 0 0
HaMerkaz
Country [23] 0 0
Israel
State/province [23] 0 0
Tel-Aviv
Country [24] 0 0
Italy
State/province [24] 0 0
Firenze
Country [25] 0 0
Italy
State/province [25] 0 0
Roma
Country [26] 0 0
Japan
State/province [26] 0 0
Aichi
Country [27] 0 0
Japan
State/province [27] 0 0
Kyoto
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei City
Country [34] 0 0
Turkey
State/province [34] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genmab
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL)
and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with
these malignancies, leaving a very small population of relapsed/refractory disease with a
poor prognosis. The purpose of this study is to assess the safety and tolerability of
epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell
neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia.
Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of
relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive
subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of
relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages
of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at
50 sites globally.

Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be
followed for a minimum of 3 years after enrollment.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, questionnaires and side effects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05206357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05206357