NIVO-ALCL
Research type
Research Study
Full title
Phase II trial of nivolumab for pediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of response in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2)
IRAS ID
1004793
Contact name
Amos Burke
Contact email
Sponsor organisation
Gustave Roussy
Eudract number
2018-001447-31
Clinicaltrials.gov Identifier
Research summary
Anaplastic large cell lymphoma (ALCL) is a rare Non-Hodgkin Lymphoma, which when occurring throughout the body (systemic) can be divided into 2 groups, depending on whether the lymphoma cells produce an abnormal form of protein called anaplastic lymphoma kinase (ALK). Both groups are aggressive (fast-growing) lymphomas, but the disease course is considered different in ALK-positive (ALK+) ALCL to ALK-negative ALCL.
For a significant proportion of patients, the disease either comes back after treatment (relapse) or does not respond to treatment (refractory). NIVO-ALCL is specifically designed for relapsed/refractory ALK+ ALCL patients.
Notably, despite improvements in treatment for these patients, there remains no accepted ‘gold standard’. Furthermore most current treatments involve stem cell transplant using the patient’s own stem cells or those from a donor, and transplants are associated with some serious and long-term side-effects and can be fatal.
In NIVO-ALCL, an immunotherapy drug (nivolumab) will be used to treat the relapsed/refractory ALK+ ALCL, and it's effectiveness will be assessed according to set criteria. Nivolumab works with cells in the immune system (called T cells) that recognise and attack threats to the body, such as cancer cells.
NIVO-ALCL will recruit 2 cohorts of patients:
Cohort 1: Patients with active progressive disease after prior treatment will be treated with nivolumab alone for 24 months. Response will be assessed in terms of acceptable overall objective response within the first 24 weeks of treatment.Cohort 2: Patients with complete remission after prior relapse therapy being considered for stem cell transplant as consolidation. In NIVO-ALCL, they will instead be treated with nivolumab alone for 24 months. Response will be assessed by progression free survival rate after trial entry and avoidance of the need for transplant.
Up to 43 patients will be included in the trial across the two cohorts internationally.REC name
Wales REC 5
REC reference
22/WA/0360
Date of REC Opinion
1 Jun 2023
REC opinion
Favourable Opinion