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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Genmab
Study ID
NCT05206357
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 4, 2022
Status verified
Apr 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 3 Years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital /ID# 240854Palo AltoCalifornia94304-
Nicklaus Children's Hospital /ID# 241174MiamiFlorida33155-3009-
New York Medical College /ID# 239208ValhallaNew York10595-
Levine Children's Hospital /ID# 242765CharlotteNorth Carolina28203-
Cincinnati Childrens Hospital Medical Center /ID# 239823CincinnatiOhio45229-
Children's Hospital of Philadelphia - Main /ID# 239294PhiladelphiaPennsylvania19104-4319-
St Jude Children's Research Hospital /ID# 239184MemphisTennessee38105-
University of Texas Southwestern Medical Center /ID# 240892DallasTexas75390-7208-

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By research site
Lucile Packard Children's Hospital· Palo Alto, CANicklaus Children's Hospital· Miami, FLNew York Medical College· Valhalla, NYLevine Children's Hospital· Charlotte, NCCincinnati Childrens Hospital Medical Center· Cincinnati, OHChildren's Hospital of Philadelphia - Main· Philadelphia, PA

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