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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

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ClinicalTrials.gov Identifier: NCT05206357
Recruitment Status : Recruiting
First Posted : January 25, 2022
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease Intervention/treatment Phase
Indolent Non-hodgkin Lymphoma Drug: Epcoritamab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms
Actual Study Start Date : June 7, 2022
Estimated Primary Completion Date : June 18, 2027
Estimated Study Completion Date : June 18, 2027


Arm Intervention/treatment
Experimental: Epcoritamab
Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 3 Years ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  2. Maximum Observed Concentration (Cmax) [ Time Frame: Up to Approximately Week 37 ]
    Maximum observed concentration.

  3. Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau) [ Time Frame: Up to Approximately Week 37 ]
    AUC from time 0 to time of last measurable concentration within the dosing interval.


Secondary Outcome Measures :
  1. Percentage of Participants who Achieve Complete Response (CR) [ Time Frame: Up to Approximately 1 Year ]
    CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).

  2. Number of Participants with Event-free survival (EFS) [ Time Frame: Up to Approximately 3 Years ]
    EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.

  3. Number of Participants who Achieve Overall Survival (OS) [ Time Frame: Up to Approximately 3 Years ]
    OS will be defined as the number of days from screening to the date of death from any cause.

  4. Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy [ Time Frame: Up to Approximately 1 Year ]
    Rate of initiation of stem cell transplantation or CAR-T therapy.

  5. Percentage of Participants Achieving Overall Response (OR) [ Time Frame: Up to Approximately 1 Year ]
    OR is assessed as the percentage of participants with an overall response.

  6. Duration of response (DOR) [ Time Frame: Up to Approximately 1 Year ]
    DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.

  7. Duration of CR (DOCR) [ Time Frame: Up to Approximately 1 Year ]
    DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.

  8. Percentage of Participants Achieving Immunogenicity [ Time Frame: Up to Approximately Week 37 ]
    Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

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): NCT05206357


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 44 study locations
Sponsors and Collaborators
AbbVie
Genmab
Investigators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05206357    
Other Study ID Numbers: M20-429
2021-004555-16 ( EudraCT Number )
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Indolent Non-hodgkin Lymphoma
ABBV-GMAB-3013
Epcoritamab
Burkitt's or Burkitt-like Lymphoma/Leukemia
Diffuse Large B-cell Lymphoma
Aggressive Mature (CD20+) B-cell Lymphoma
Cancer
Relapsed/Refractory Aggressive Mature B-cell Neoplasms
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Aggression
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms