NIVO-ALCL (anaplastic large cell lymphoma)
Active, not recruiting
Who can enter
Children with ALK+ anaplastic large-cell lymphoma (ALCL), in case of recurrence or progression, or in remission after a recurrence
Children 6 months of age and older
Goal
Goal
In this study, we look at the efficacy and safety of nivolumab in children with a relapse or refractory ALCL (cohort 1) or children in whom the disease is no longer apparent (in complete remission) after a relapse (cohort 2).
Background
Background
Nivolumab is a drug that activates the body's own immune system so that it can attack cancer cells. In adult patients, nivolumab has already been investigated for diseases such as bladder cancer and lung cancer. It was found that in some adults the tumor disappears. Nivolumab is being tested in many types of cancer in adults and children, including Hodgkin's lymphoma, where it has been shown to work well in children.
In children with relapsed or refractory ALCL, the disease has come back (relapse), or has not responded (well) to previous treatment (refractory). In this study, we want to investigate if nivolumab works in these children.
Children with early recurrence or refractory ALCL who are in remission after treatment normally receive a stem cell transplant. This is a heavy procedure. In this study, we want to investigate if we can replace the stem cell transplant with treatment with nivolumab.
This is an open-label study. This means that all children who take part in the study will be treated with nivolumab. The treatment lasts a maximum of two years.
This study is now closed for inclusion.
Last reviewed
Last reviewed
March 23, 2026
Study details
- Study details
Official 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) (NIVO-ALCL)Cancer type
Anaplastic large cell lymphoma (ALCL)Phase
2Maximum number of patients
43, of whom 2 are expected to participate in the NetherlandsStart date
December 22, 2022Status
Closed for inclusionLocal principal investigator
Dr. A. BeishuizenSponsor
Gustave Roussy hospital, ParisApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
ClinicalTrials.gov: NCT03703050
Clinicaltrialsregister.eu: 2018-001447-31
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.