Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

Sponsor
University of Birmingham
Study ID
NCT05848765
Phase
PHASE2
Status
Recruiting
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Conditions

  • Refractory Follicular Lymphoma
  • Relapsed Follicular Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Bispecific antibody
  • Lenalidomide — DRUG
    Immunomodulatory agent
  • Rituximab — DRUG
    Monoclonal antibody
  • Obinutuzumab — DRUG
    Monoclonal antibody
  • Bendamustine — DRUG
    Alkylating agent (chemotherapy drug)
  • Vincristine — DRUG
    Antineoplastic, Vinca Alkaloid
  • Doxorubicin — DRUG
    Anthracycline
  • Cyclophosphamide — DRUG
    Alkylating agent (chemotherapy drug)
  • Prednisone — DRUG
    Corticosteroid
  • Investigation agent 2 — DRUG
    The drug used in round 2 is yet to be confirmed, round 2 is estimated to open in Q4 2025 and the record will be updated when the drug has been confirmed
  • Investigation agent 3 — DRUG
    The drug used in round 3 is yet to be confirmed, round 3 is estimated to open in Q3 2027 and the record will be updated when the drug has been confirmed

Study Details

The aim of the REFRACT clinical trial is to find new therapies with improved outcomes compared to the current standard treatment available, in patients with relapsed or refractory follicular lymphoma. This will be done by comparing patients who have received a new treatment against patients who receive standard treatment based on their response to the treatment received.

Key Dates

Start date
Sep 4, 2023
Status verified
Apr 2026
Primary completion
May 31, 2029
Completion
Nov 30, 2031

Study Design

Enrollment
284 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Round 1: Epcoritamab and lenalidomide
    Epcoritamab (weekly for cycles 1 and 2 and on day 1 of cycles 3-12 for up to 12 cycles) and lenalidomide (daily for days 1-21 of each cycle for up for 12 cycles), cycles will be 28 day cycles.
  • Experimental: Round 2
    Investigation agent 2
  • Experimental: Round 3
    Investigation agent 3
  • Active Comparator: All rounds: Investigator Choice Therapy
    Choice of therapy to be selected by the Investigator for each patient prior to randomisation. The Investigator will choose between; RCHOP, RCVP, rituximab and bendamustine, rituximab and lenalidomide or bendamustine and obinutuzumab.

Primary Outcome Measure

Complete metabolic response (CMR) [ Time Frame: 24 weeks ]

Central Contacts

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