Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patien… (NCT03703050) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2)
Denmark, France45 participantsStarted 2019-01-02
Plain-language summary
Prospective, non-randomized, single arm phase II trial with 2 cohorts of ALK+ ALCL treated with nivolumab
Who can participate
Age range6 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All criteria from I-1 to I-10 are required for all patients, in addition of the cohort-specific criteria
I-1. Histologically confirmed evidence of relapsed/refractory ALK+ ALCL. If biopsy could not be performed, relapsed/refractory status should be confirmed by molecular analysis whenever possible (increase of MRD quantitative PCR at 2 consecutive measures qualifying for a significant increase according to the same reference laboratory, with clinical signs and symptoms suggestive of progressing disease). In this case, relapsed/refractory status must be reviewed and confirmed by the international coordinating investigator.
I-2. Age at inclusion \> 6 months
I-3. No washout needed, but patients must have recovered from acute toxic effects of all prior therapy before enrollment into the study. A short course of steroids is allowed at the beginning of Nivolumab if it is clinical indicated
I-4. Adequate organ function:
* Peripheral absolute neutrophil count (ANC) ≥750/μL in patients without bone marrow involvement and ≥500/μL in patients with bone marrow involvement (unsupported)
* Platelet count ≥75,000/μL in patients without bone marrow involvement and 50 000 in patients with bone marrow involvement (unsupported)
* Hemoglobin ≥8.0 g/dL (transfusion is allowed)
* Serum creatinine ≤1.5 x upper limit of normal (ULN) for age
* Total bilirubin ≤1.5 x ULN in patients without liver involvement and \< 2.5 ULN in patients with liver involvement
* Alanine aminotra…