Randomized Phase 2 Study Of Epcoritamab Vs Watch And Wait InPatients With Previously Untreated Low Tumor Burden FollicularLymphoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To compare the time to next treatment between patients with previously untreated, low tumor burden FL who receive the study drug epcoritamab versus those who do not receive epcoritamab and are monitored only.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically diagnosed follicular lymphoma grade 1-3a

Within 6 months from the diagnosis of follicular lymphoma

Have no prior systemic treatment for lymphoma

Stage II (non-contiguous), III or IV disease

Disqualifiers

Known active central nervous system lymphoma or leptomeningeal disease

Adequately treated localized skin cancer without evidence of disease.

Adequately treated breast cancer without evidence of disease.

Adequately treated prostate cancer or monitored with watch and wait for low risk disease without evidence of progressive disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • Epcoritamab

    Drug

    Given by Injection

  • Observation

    Other intervention

    Participant will be closely monitored until the disease gets worse and requires treatment, as determined by your treating doctor or at your request.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: EPCORI ArmExperimental treatment 1 intervention
Group B: OBS ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and adverse events (AEs).

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: