Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Conditions

• Follicular Lymphoma (FL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epcoritamab — DRUG
  Subcutaneous (SC) Injection
• Prednisone — DRUG
  Oral Tablet
• Rituximab — DRUG
  Intravenous (IV) Infusion
• Lenalidomide — DRUG
  Oral Capsule
• Doxorubicin — DRUG
  IV Injection
• Vincristine — DRUG
  IV Injection
• Cyclophosphamide — DRUG
  IV Injection
• Obinutuzumab — DRUG
  IV Infusion
• Bendamustine — DRUG
  IV Infusion

Study Details

Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date

Feb 5, 2024

Status verified

Jun 2026

Primary completion

Nov 30, 2037

Completion

Nov 30, 2037

Study Design

Enrollment

1,095 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)
  Participants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
• Experimental: Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)
  Participants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
• Experimental: Arm B: Chemoimmunotherapy (CIT) Option A
  Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
• Experimental: Arm B: Chemoimmunotherapy (CIT) Option B
  Participants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.
• Experimental: Arm C: Lenalidomide and Rituximab (R2)
  Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.

Primary Outcome Measure

Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30) [ Time Frame: Up to 30 Months ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (58)

Find similar trials in Fresno, CA

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